{"schemaVersion":"wpf-profile-export-v1","exportedAt":"2026-09-24T04:44:34.456Z","profile":{"slug":"bremelanotide","name":"Bremelanotide","aliases":[],"category":"Melanocortin receptor agonist peptide"},"synthesis":{"mechanism":"Bremelanotide is a melanocortin receptor agonist peptide studied in sexual-desire disorders. The relevant clinical populations, outcome measures, and treatment settings must be distinguished from other melanocortin compounds.","evidence":"WPF’s atlas lists clinical-trial reviews of pharmacological options for hypoactive sexual desire disorder, as well as prescribing-pattern and formulation studies. A review or utilization trend does not by itself establish an individual treatment effect or extend findings to unstudied populations.","safety":"Trial endpoints, enrolled populations, contraindications, and adverse events require appraisal of primary and official records before a clinical or regulatory claim is made.","observationalBoundary":"WPF's separate observational archive may include contributor reports concerning bremelanotide's use for sexual-desire-related outcomes. As with every entry in that archive, these de-identified reports can suggest questions but cannot establish causation, efficacy, comparative safety, or event frequency, and should not be conflated with reports about other melanocortin compounds.","openQuestions":"Which outcomes have controlled trial support in the studied population? How do safety and tolerability compare under the actual trial designs? What regulatory indications and restrictions apply in each jurisdiction?"},"completion":{"version":"wpf-profile-v1.1","verifiedSourceCount":30,"evidenceDepth":"depth_target_met","complete":false,"checks":[{"key":"overview","passed":true,"actual":225,"required":100,"severity":"blocking"},{"key":"evidence_summary","passed":true,"actual":297,"required":100,"severity":"blocking"},{"key":"safety_summary","passed":true,"actual":173,"required":100,"severity":"blocking"},{"key":"archive_boundary","passed":true,"actual":381,"required":75,"severity":"blocking"},{"key":"open_questions","passed":true,"actual":215,"required":75,"severity":"blocking"},{"key":"verified_sources","passed":true,"actual":30,"required":1,"severity":"blocking"},{"key":"evidence_depth_target","passed":true,"actual":30,"required":25,"severity":"warning"},{"key":"reviewed_sources","passed":false,"actual":0,"required":1,"severity":"blocking"},{"key":"chemistry","passed":true,"actual":true,"required":true,"severity":"blocking"},{"key":"regulatory_context","passed":true,"actual":2,"required":2,"severity":"blocking"},{"key":"claims","passed":false,"actual":0,"required":1,"severity":"blocking"},{"key":"claim_traceability","passed":true,"actual":0,"required":0,"severity":"blocking"},{"key":"regulatory_freshness","passed":true,"actual":0,"required":0,"severity":"warning"}],"failures":["reviewed_sources","claims"]},"chemistry":{"id":"0d05fe17-22b5-4666-8f5e-2c9b7f93be86","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","molecularFormula":"C50H68N14O10","molecularWeight":1025.2,"aminoAcidSequence":null,"smiles":"CCCCC(C(=O)NC1CC(=O)NCCCCC(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC1=O)CC2=CN=CN2)CC3=CC=CC=C3)CCCN=C(N)N)CC4=CNC5=CC=CC=C54)C(=O)O)NC(=O)C","inchi":"InChI=1S/C50H68N14O10/c1-3-4-16-35(58-29(2)65)43(67)64-41-25-42(66)54-20-11-10-18-37(49(73)74)60-46(70)39(23-31-26-56-34-17-9-8-15-33(31)34)62-44(68)36(19-12-21-55-50(51)52)59-45(69)38(22-30-13-6-5-7-14-30)61-47(71)40(63-48(41)72)24-32-27-53-28-57-32/h5-9,13-15,17,26-28,35-41,56H,3-4,10-12,16,18-25H2,1-2H3,(H,53,57)(H,54,66)(H,58,65)(H,59,69)(H,60,70)(H,61,71)(H,62,68)(H,63,72)(H,64,67)(H,73,74)(H4,51,52,55)/t35-,36-,37-,38+,39-,40-,41-/m0/s1","inchikey":"FFHBJDQSGDNCIV-MFVUMRCOSA-N","structureImageUrl":"https://pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/9941379/PNG","createdAt":"2026-09-23T02:36:53.645Z","updatedAt":"2026-09-23T02:36:53.645Z"},"evidence":[{"id":"51c6f730-79d9-40e1-a685-3b40171d8c67","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/39793696/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder.\" Abstract excerpt: Hypoactive sexual desire disorder (HSDD) is the most reported sexual dysfunction among premenopausal women worldwide. Bremelanotide, trade name Vyleesi, has been approved by the United States Food and Drug Administration to treat HSDD. However, despite approval, very little is known about its neurobiological mechanism of action. In this study, we utilized a female Syrian hamster model to investiga","authors":null,"publishingOrg":null,"publicationYear":2025,"doi":"10.1016/j.neuropharm.2025.110299","pubmedId":"39793696","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=118, totalMentions=5). Imported evidence lane: preclinical_animal. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.neuropharm.2025.110299","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.747Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"6cbf0201-f722-497e-a183-48c5f88855ac","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells <i>via</i> Suppression of Survivin Expression.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/39197897/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells <i>via</i> Suppression of Survivin Expression.\" Abstract excerpt: Glioblastoma is the most aggressive form of brain tumor and has a dismal prognosis; therefore, novel therapeutic approaches based on the mechanisms underlying its aggressive nature are urgently required. A growing body of evidence suggests that neurotransmitters play a key role in modulating the biology of glioblastoma; however, the role of melanocortins remains unclear. The effects of bremelanoti","authors":null,"publishingOrg":null,"publicationYear":2024,"doi":"10.21873/anticanres.17214","pubmedId":"39197897","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=389, totalMentions=6). Imported evidence lane: preclinical_animal. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.21873/anticanres.17214","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.600Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"e2addb98-725b-4662-a901-9240fafeae6e","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/36809187/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.\" Abstract excerpt: Efficacy outcomes are only informative to the extent that they are validated. We examined the measurement properties of efficacy measures from the phase III (\"RECONNECT\") bremelanotide trials for hypoactive sexual desire disorder (HSDD) in women. Continuous efficacy outcomes, including a) the Female Sexual Function Index (FSFI) and its Desire domain (FSFI-D) and b) the Female Sexual Distress Scale","authors":null,"publishingOrg":null,"publicationYear":2024,"doi":"10.1080/00224499.2023.2175192","pubmedId":"36809187","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=171, totalMentions=2). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1080/00224499.2023.2175192","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.891Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"3f229f27-b578-4636-8e22-8b2be5d4a19b","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/36242769/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder.\" Abstract excerpt: Female sexual response implies a deep intertwining between psychosocial and neurobiological mediators. Regulation of central melanocortin signaling may enhance sexual desire. In premenopausal women with hypoactive sexual desire disorder (HSDD), melanocortin receptor agonist bremelanotide (Vyleesi) has been hypothesized to trigger excitatory brain pathways. Hereby we summarize bremelanotide's propo","authors":null,"publishingOrg":null,"publicationYear":2023,"doi":"10.1080/14656566.2022.2132144","pubmedId":"36242769","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=275, totalMentions=4). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1080/14656566.2022.2132144","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.451Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"032de332-95fb-4a47-ba55-6ae7eec95e1d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/35170192/","evidenceTier":"phase_1_2","summary":"Content-verified record concerning Bremelanotide: \"Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.\" Abstract excerpt: The melanocortin 4 receptor (MC4R) plays a central role in appetite regulation, and agonistic activity at this receptor promotes satiety. Results from two randomized controlled clinical trials examine the effects of bremelanotide's agonism at MC4R on caloric intake and body weight. Premenopausal women with a body mass index &gt;30 kg/m 2 were studied in two phase 1, single-centre, randomized, doub","authors":null,"publishingOrg":null,"publicationYear":2022,"doi":"10.1111/dom.14672","pubmedId":"35170192","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=216, totalMentions=8). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1111/dom.14672","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.379Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"eb0b4845-0150-4a88-9137-9f88a2aca4e9","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/35230162/","evidenceTier":"phase_3","summary":"Content-verified record concerning Bremelanotide: \"Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.\" Abstract excerpt: Background: Hypoactive sexual desire disorder (HSDD), the most prevalent female sexual dysfunction, is characterized as persistent diminished desire for sexual activity accompanied by distress. The efficacy and safety of bremelanotide, a melanocortin receptor agonist approved by the U.S. Food and Drug Administration for treatment of acquired generalized HSDD in premenopausal women, were establishe","authors":null,"publishingOrg":null,"publicationYear":2022,"doi":"10.1089/jwh.2021.0225","pubmedId":"35230162","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=221, totalMentions=8). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1089/jwh.2021.0225","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:47.110Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"90ef21a1-f637-41f8-9ec8-5f993ab680be","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Safety Profile of Bremelanotide Across the Clinical Development Program.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/35147466/","evidenceTier":"laboratory","summary":"Summarizes safety observations across the bremelanotide development program; population and study design limits apply.","authors":null,"publishingOrg":null,"publicationYear":2022,"doi":"10.1089/jwh.2021.0191","pubmedId":"35147466","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Upgraded from an entered/unverified draft to a content-verified citation. Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=12, totalMentions=9). Imported evidence lane: laboratory_mechanistic. Source provider: WPF seed. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":"This publication addresses Bremelanotide in the specific setting identified in its title.","supportNature":"Screened source-level context; specific outcomes and evidence tier await appraisal.","qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1089/jwh.2021.0191","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T02:12:05.138Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"2a4da544-e7cf-40f8-aef4-a7ecaad63137","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/33455598/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women.\" Abstract excerpt: Hypoactive sexual desire disorder (HSDD) is a common female sexual dysfunction and is estimated to affect approximately 10% of women in the United States. It has been suggested that HSDD is associated with an imbalance of hormone and neurotransmitter levels in the brain, resulting in decreased excitation, increased inhibition, or a combination of both. Evidence suggests neurotransmitters, includin","authors":null,"publishingOrg":null,"publicationYear":2022,"doi":"10.1017/s109285292100002x","pubmedId":"33455598","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: preclinical_animal. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1017/s109285292100002x","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.261Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"cbc2ada4-98af-4606-b85f-98aa9141607d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/34642243/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.\" Abstract excerpt: The US Food and Drug Administration (FDA) has approved two drugs for 'hypoactive sexual desire disorder' in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every t","authors":null,"publishingOrg":null,"publicationYear":2021,"doi":"10.1136/dtb.2021.000020","pubmedId":"34642243","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=147, totalMentions=3). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1136/dtb.2021.000020","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:45.860Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"e818f246-27ac-4136-b6cb-ad6ecc1a947d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Failure of a Meta-analysis: A Commentary on Glen Spielmans's \"Re-Analyzing Phase III Bremelanotide Trials for 'Hypoactive Sexual Desire Disorder in Women'\".","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/33835907/","evidenceTier":"phase_3","summary":"Content-verified record concerning Bremelanotide: \"Failure of a Meta-analysis: A Commentary on Glen Spielmans's \"Re-Analyzing Phase III Bremelanotide Trials for 'Hypoactive Sexual Desire Disorder in Women'\".\" (identity confirmed; no abstract text available to excerpt.)","authors":null,"publishingOrg":null,"publicationYear":2021,"doi":"10.1080/00224499.2021.1902926","pubmedId":"33835907","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1080/00224499.2021.1902926","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.411Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"b0775f82-58f6-4946-8737-dfb61aace05b","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/33245851/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs.\" Abstract excerpt: The spread of performance and image enhancing drugs (PIEDs) often requires forensic toxicology laboratories to identify unknown compounds without reference standards. We characterized the PIEDs melanotan II and bremelanotide, not legally marketed, in eight unknown samples confiscated by police together with anabolic steroids, hormone modulators, sexual enhancers and stimulants, intended for the bl","authors":null,"publishingOrg":null,"publicationYear":2021,"doi":"10.1002/dta.2986","pubmedId":"33245851","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: preclinical_animal. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1002/dta.2986","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.487Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"7751e766-e40c-4e75-998d-87ef12a64635","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Re-Analyzing Phase III Bremelanotide Trials for \"Hypoactive Sexual Desire Disorder\" in Women.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/33678061/","evidenceTier":"phase_3","summary":"Content-verified record concerning Bremelanotide: \"Re-Analyzing Phase III Bremelanotide Trials for \"Hypoactive Sexual Desire Disorder\" in Women.\" Abstract excerpt: Kingsberg et al. described results from two 24-week Phase III trials of bremelanotide for treating hypoactive sexual desire disorder (HSDD) in women. 72.72% of protocol-listed outcomes were not reported by Kingsberg et al., who provided results of 15 secondary measures which were not listed in the study protocols. None of their efficacy outcomes were reported in line with CONSORT data reporting st","authors":null,"publishingOrg":null,"publicationYear":2021,"doi":"10.1080/00224499.2021.1885601","pubmedId":"33678061","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=72, totalMentions=3). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1080/00224499.2021.1885601","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.524Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"8f6e5212-06c2-4d4e-9cd3-fda6b0b43317","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/33538638/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results.\" Abstract excerpt: Background: Hypoactive sexual desire disorder (HSDD) has a significant negative impact on women's overall health and relationships with their partners. Primary analyses from the RECONNECT clinical trials demonstrated statistically significant and clinically meaningful improvements in sexual desire and related distress with bremelanotide relative to placebo in premenopausal women with HSDD. Exit su","authors":null,"publishingOrg":null,"publicationYear":2021,"doi":"10.1089/jwh.2020.8460","pubmedId":"33538638","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=325, totalMentions=5). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1089/jwh.2020.8460","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.963Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"39cd188b-d29a-43b2-844a-99aaaac76e2b","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31893927/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.\" Abstract excerpt: Objective: To review data regarding bremelanotide, a recently approved therapy for hypoactive sexual desire disorder (HSDD). Data Sources: Literature search of Medline, SCOPUS, and EMBASE was performed using the search terms bremelanotide, bremelanotide injection, Vyleesi , and melanocortin 4 receptor agonist between January 1, 1996, and December 15, 2019. Reference lists from included articles we","authors":null,"publishingOrg":null,"publicationYear":2020,"doi":"10.1177/1060028019899152","pubmedId":"31893927","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: systematic review or meta-analysis. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=36, totalMentions=9). Imported evidence lane: synthesis. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"systematic_review_or_meta_analysis","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1177/1060028019899152","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.231Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"4984391d-1158-4b27-ac27-73d0c7cf228f","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Ultra-sensitive quantification of the therapeutic cyclic peptide bremelanotide utilizing UHPLC-MS/MS for evaluation of its oral plasma pharmacokinetics.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/32353679/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"Ultra-sensitive quantification of the therapeutic cyclic peptide bremelanotide utilizing UHPLC-MS/MS for evaluation of its oral plasma pharmacokinetics.\" Abstract excerpt: Bremelanotide (Vyleesi&#xae;), a cyclic heptapeptide, was recently approved for the subcutaneous treatment of premenopausal hypoactive sexual desire disorder. To foster the development of alternative routes of administration, we aimed at determining the oral plasma pharmacokinetics of bremelanotide in beagle dogs. Therefore, we established a UHPLC-MS/MS assay with an LLOQ of 10 pg/mL (9.8 pM) usin","authors":null,"publishingOrg":null,"publicationYear":2020,"doi":"10.1016/j.jpba.2020.113276","pubmedId":"32353679","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=0, totalMentions=5). Imported evidence lane: preclinical_animal. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.jpba.2020.113276","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:47.038Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"a06d6715-c304-44df-9c20-9a75bb964e8f","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide (Vyleesi) for hypoactive sexual desire disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31381550/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide (Vyleesi) for hypoactive sexual desire disorder.\" (identity confirmed; no abstract text available to excerpt.)","authors":null,"publishingOrg":null,"publicationYear":2019,"doi":null,"pubmedId":"31381550","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: systematic review or meta-analysis. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: synthesis. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"systematic_review_or_meta_analysis","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"pmid:31381550","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.108Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"32fb1c69-bc5d-4d80-b90c-7ee432ddca4c","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31599840/","evidenceTier":"phase_3","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.\" Abstract excerpt: To evaluate the safety and efficacy of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder. Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorde","authors":null,"publishingOrg":null,"publicationYear":2019,"doi":"10.1097/aog.0000000000003500","pubmedId":"31599840","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=39, totalMentions=6). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1097/aog.0000000000003500","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:45.932Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"ed5ff102-56df-4b3a-9680-981ba44d426f","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide: First Approval.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31429064/","evidenceTier":"laboratory","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide: First Approval.\" Abstract excerpt: Bremelanotide (Vyleesi&#x2122;) is a melanocortin receptor agonist recently approved in the USA for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty. It is a self-administered, on-demand subcutaneous therapy. Initially developed by Palatin Technolog","authors":null,"publishingOrg":null,"publicationYear":2019,"doi":"10.1007/s40265-019-01187-w","pubmedId":"31429064","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=0, totalMentions=4). Imported evidence lane: laboratory_mechanistic. Source provider: WPF seed. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1007/s40265-019-01187-w","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.086Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"19e6f378-a383-4a17-bb19-6439a4b1a974","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31599847/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.\" Abstract excerpt: To evaluate the long-term safety and efficacy of bremelanotide as treatment for hypoactive sexual desire disorder in premenopausal women. Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, co","authors":null,"publishingOrg":null,"publicationYear":2019,"doi":"10.1097/aog.0000000000003514","pubmedId":"31599847","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=49, totalMentions=4). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1097/aog.0000000000003514","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.675Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"1f424259-fee9-4ae5-9bc2-ce45daa1bcc7","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31277966/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.\" Abstract excerpt: Responder analyses are used to determine whether changes that occur during a clinical trial are clinically meaningful; for subjective endpoints such as those based on patient-reported outcomes (PROs), responder analyses are particularly useful. To identify the minimal clinically important difference (MCID) for selected scores on questionnaires assessing female sexual functioning and to use these d","authors":null,"publishingOrg":null,"publicationYear":2019,"doi":"10.1016/j.jsxm.2019.05.012","pubmedId":"31277966","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.jsxm.2019.05.012","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.336Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"fcf3557a-3583-4c73-8a7d-053a7479464d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/28189361/","evidenceTier":"phase_1_2","summary":"Content-verified record concerning Bremelanotide: \"Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants.\" Abstract excerpt: This was a Phase I study to evaluate the safety, tolerability, and hemodynamic and pharmacokinetic effects of bremelanotide (BMT) coadministered with ethanol to healthy male and female participants. This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study. Individuals meeting the inclusion/exclusion criteria received BMT or placebo with or without ethanol at the res","authors":null,"publishingOrg":null,"publicationYear":2017,"doi":"10.1016/j.clinthera.2017.01.018","pubmedId":"28189361","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.clinthera.2017.01.018","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.563Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"f5e12c72-70a0-421f-8f74-f2fb9aeb7b43","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/27977473/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide.\" Abstract excerpt: Melanocortin receptor agonists that bind to the melanocortin receptor 4 may cause increases in blood pressure (BP). Bremelanotide is an on-demand, subcutaneous melanocortin-receptor agonist that binds to the melanocortin receptor 4 and is being developed for the treatment of female sexual dysfunction. We studied the effects of bremelanotide administration on ambulatory BP and heart rate (HR), in a","authors":null,"publishingOrg":null,"publicationYear":2017,"doi":"10.1097/hjh.0000000000001221","pubmedId":"27977473","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=116, totalMentions=4). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1097/hjh.0000000000001221","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:47.188Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"22204493-0c09-4b74-8112-4902f68d0285","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/27181790/","evidenceTier":"phase_1_2","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.\" Abstract excerpt: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women. Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sex","authors":null,"publishingOrg":null,"publicationYear":2016,"doi":"10.2217/whe-2016-0018","pubmedId":"27181790","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.2217/whe-2016-0018","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:18.955Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"6cfa1048-594a-4123-a4c4-35095f380bb4","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Re: Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/27751477/","evidenceTier":"phase_1_2","summary":"Content-verified record concerning Bremelanotide: \"Re: Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial.\" (identity confirmed; no abstract text available to excerpt.)","authors":null,"publishingOrg":null,"publicationYear":2016,"doi":"10.1016/j.juro.2016.08.063","pubmedId":"27751477","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.juro.2016.08.063","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.184Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"8abaee3e-a952-4e61-86e4-680251b95ea9","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/34436837/","evidenceTier":"laboratory","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide.\" Abstract excerpt: Bremelanotide is a parenterally administered melanocortin receptor agonist that is used to treat female hypoactive sexual desire disorder. Bremelanotide has been reported to cause mild serum enzyme elevations during therapy and has been implicated in rare instances of clinically apparent acute liver injury.","authors":null,"publishingOrg":null,"publicationYear":2012,"doi":null,"pubmedId":"34436837","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: reference/monograph-type record (PubMed book/reference-work entry) -- real and traceable, not primary research. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=0, totalMentions=2). Imported evidence lane: laboratory_mechanistic. Source provider: WPF seed. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"other","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"pmid:34436837","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.159Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"d019259c-4e69-4c5d-bfb2-4ddb562230ab","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/18206919/","evidenceTier":"phase_1_2","summary":"Content-verified record concerning Bremelanotide: \"Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.\" Abstract excerpt: We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil. A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar reg","authors":null,"publishingOrg":null,"publicationYear":2008,"doi":"10.1016/j.juro.2007.10.063","pubmedId":"18206919","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=51, totalMentions=6). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1016/j.juro.2007.10.063","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.820Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"40425b4c-25c4-4b33-ba06-dfdd98610d0d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide: an overview of preclinical CNS effects on female sexual function.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/17958619/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide: an overview of preclinical CNS effects on female sexual function.\" Abstract excerpt: Bremelanotide is an analogue of the naturally occurring peptide alpha-melanocyte-stimulating hormone (alpha-MSH). It stimulates erection in men and male rats, and is currently in clinical trials for the treatment of erectile dysfunction. To review the effects of bremelanotide, an analogue of the naturally occurring peptide alpha-MSH, on the preclinical indices of sexual desire in female rats, and ","authors":null,"publishingOrg":null,"publicationYear":2007,"doi":"10.1111/j.1743-6109.2007.00610.x","pubmedId":"17958619","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=0, totalMentions=6). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1111/j.1743-6109.2007.00610.x","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.009Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"1f511f6b-dfd7-41ad-ad0b-a058e2718e37","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/16839319/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.\" Abstract excerpt: Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of alpha-melanocyte-stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R. To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premeno","authors":null,"publishingOrg":null,"publicationYear":2006,"doi":"10.1111/j.1743-6109.2006.00268.x","pubmedId":"16839319","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=83, totalMentions=11). Imported evidence lane: human_interventional. Source provider: Europe PMC. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"doi:10.1111/j.1743-6109.2006.00268.x","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:47.269Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"d2423cd3-e0c1-4e2a-b54e-28af9b455e3d","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"Bremelanotide.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/31369224/","evidenceTier":"insufficient","summary":"Content-verified record concerning Bremelanotide: \"Bremelanotide.\" Abstract excerpt: No information is available on the clinical use of bremelanotide during breastfeeding. Because bremelanotide is a cyclic peptide molecule with a molecular weight of 1025, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, bremelanotide should be used with caution during br","authors":null,"publishingOrg":null,"publicationYear":2006,"doi":null,"pubmedId":"31369224","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: reference/monograph-type record (PubMed book/reference-work entry) -- real and traceable, not primary research. Verified by content, not title or identifier alone: abstract_confirms_peptide_as_subject (firstMentionChar=51, totalMentions=3). Imported evidence lane: synthesis. Source provider: WPF seed. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"other","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"pmid:31369224","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:28:46.306Z","updatedAt":"2026-09-23T23:29:22.566Z"},{"id":"56100523-4218-4394-8b51-bbb844d47355","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","title":"PT-141 Palatin.","sourceUrl":"https://pubmed.ncbi.nlm.nih.gov/15134289/","evidenceTier":"animal","summary":"Content-verified record concerning Bremelanotide: \"PT-141 Palatin.\" Abstract excerpt: Palatin, under license from Competitive Technology, is developing the peptide PT-141, a synthetically modified analog of PT-14, as a nasal spray for the potential treatment of erectile dysfunction (ED) and female sexual dysfunction. In September 2003, Palatin had completed a phase IIb trial in patients with ED and in February 2004, Palatin planned to start phase III trials in early 2005.","authors":null,"publishingOrg":null,"publicationYear":2004,"doi":null,"pubmedId":"15134289","jurisdiction":null,"dateAccessed":null,"editorialNotes":"Category: primary research record. Verified by content, not title or identifier alone: pubmed_curated_indexing_confirms_subject (matched: \"bremelanotide\"). Imported evidence lane: preclinical_animal. Source provider: WPF seed. Content-verified for the 13-profile directory completion effort (2026-09) using free NCBI PubMed E-utilities; no paid API used.","sourceType":"peer_reviewed_research","claimSupported":null,"supportNature":null,"qualification":null,"verificationStatus":"verified","publicationStatus":"published","addedById":null,"machineActor":"wpf-directory-completion-content-verified-2026-09","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","canonicalSourceIdentity":"pmid:15134289","sourceIdentityId":null,"sourceStatus":"active","sourceContentHash":null,"sourceVersion":1,"retrievedAt":null,"retrievalProvider":null,"retrievalPayloadRef":null,"evidenceLane":null,"extractionPayload":null,"provenancePayload":null,"validationGates":null,"engineState":"manual","engineRunId":null,"createdAt":"2026-09-23T22:43:19.032Z","updatedAt":"2026-09-23T23:29:22.566Z"}],"regulatory":[{"id":"c29f5165-0311-4f06-8bec-418a96ee40e8","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","jurisdiction":"European Union — EMA","status":"not_approved","approvedIndication":null,"rationale":"No centrally authorized EMA medicine containing bremelanotide was identified in the EMA medicines database as of 2026-09-23. Palatin Technologies licensed European rights for bremelanotide to Gedeon Richter in 2014; that licensing agreement was terminated in September 2016 with no EU marketing authorization resulting. Bremelanotide (Vyleesi) is FDA-approved in the United States only. Absence of a record in this search is not proof that no authorization exists via another regulatory pathway (e.g. national member-state authorization outside the centralized procedure). Status remains jurisdiction-, product-, and date-specific.","sourceTitle":"European Medicines Agency medicines database","sourceUrl":"https://www.ema.europa.eu/en/medicines","dateChecked":"2026-09-23T00:00:00.000Z","reviewDueAt":"2026-12-22T00:00:00.000Z","enteredById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","publicationStatus":"published","factualObservationId":null,"createdAt":"2026-09-23T02:42:17.772Z","updatedAt":"2026-09-23T23:29:22.653Z"},{"id":"35978346-76a0-48cd-9416-5da6f59bc6cf","peptideId":"57147aff-bc28-4d70-8bba-1cb41386e574","jurisdiction":"United States — FDA","status":"approved","approvedIndication":"VYLEESI (bremelanotide) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty, and not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance. Not indicated for HSDD in postmenopausal women or in men.","rationale":"FDA labeling identifies VYLEESI (bremelanotide injection) as an approved product for its labeled indication; this record does not extend approval to other populations or uses.","sourceTitle":"FDA VYLEESI (bremelanotide injection) prescribing information","sourceUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf","dateChecked":"2026-09-23T00:00:00.000Z","reviewDueAt":null,"enteredById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","reviewedById":"0bf5b853-ea8b-4aa3-bffe-2af0fdd75150","publicationStatus":"published","factualObservationId":null,"createdAt":"2026-09-23T02:14:11.710Z","updatedAt":"2026-09-23T23:29:22.653Z"}],"claims":[],"correctionHistory":[],"boundaries":{"observationsAreEvidence":false,"completionIsPublicationApproval":false,"medicalAdvice":false}}