Scientific intelligence record
Experience 2.0
Melanocortin receptor agonist peptide
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.
Record status
Traceability partial
Last meaningful update: 9/23/2026
Ranked research corpus
181
Categorized publications with transparent machine-proposed ranking; human appraisal pending.
global evidence atlas
This is a deduplicated literature screening registry—not a claim that every mention directly proves efficacy or safety. Machine proposals remain visibly separate from governed human appraisal.
181 matching records · ranked 2026-09-18
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OpenAlex · 2026 · Source ID doi:10.1093/jsxmed/qdag063.057 · DOI 10.1093/jsxmed/qdag063.057
contextual-unclassified
Europe PMC · 2026 · PMID 42254382 · DOI 10.3389/fmed.2026.1789809
synthesis
Europe PMC · 2026 · PMID 42485063 · DOI 10.1039/d6ay01098a
synthesis
Europe PMC · 2026 · PMID 42041173 · DOI 10.1002/ddr.70293
preclinical-animal
Europe PMC · 2026 · PMID 40543759 · DOI 10.1016/j.jmig.2025.06.004
synthesis
Europe PMC · 2026 · PMID 42340853 · DOI 10.1021/acs.jmedchem.6c01074
preclinical-animal
Europe PMC · 2026 · PMID 42144994 · DOI 10.1080/0092623x.2026.2651862
human-interventional
Europe PMC · 2026 · PMID 41960633 · DOI 10.1097/jcp.0000000000002179
contextual-unclassified
Europe PMC · 2026 · PMID 41419078 · DOI 10.1016/j.jmig.2025.12.021
preclinical-animal
OpenAlex · 2026 · Source ID doi:10.65671/g269y606 · DOI 10.65671/g269y606
contextual-unclassified
Europe PMC · 2026 · PMID 42021992 · DOI 10.3389/fragi.2026.1790247
human-interventional
OpenAlex · 2025 · Source ID doi:10.1093/jsxmed/qdaf068.108 · DOI 10.1093/jsxmed/qdaf068.108
contextual-unclassified
OpenAlex · 2025 · Source ID doi:10.1093/jsxmed/qdaf320.390 · DOI 10.1093/jsxmed/qdaf320.390
preclinical-animal
Europe PMC · 2025 · PMID 40518469 · DOI 10.1007/s00520-025-09640-1
preclinical-animal
Europe PMC · 2025 · Source ID agr:ind609222970
preclinical-animal
Europe PMC · 2025 · PMID 40513668 · DOI 10.1016/j.jconrel.2025.113947
preclinical-animal
Europe PMC · 2025 · PMID 40678415 · DOI 10.55730/1300-0152.2741
preclinical-animal
Europe PMC · 2025 · PMID 39793696 · DOI 10.1016/j.neuropharm.2025.110299
preclinical-animal
OpenAlex · 2025 · Source ID doi:10.1053/j.ajkd.2025.02.424 · DOI 10.1053/j.ajkd.2025.02.424
contextual-unclassified
Europe PMC · 2025 · PMID 39846877 · DOI 10.1097/grf.0000000000000922
preclinical-animal
Europe PMC · 2025 · PMID 38767282 · DOI 10.1177/10600280241253273
preclinical-animal
Europe PMC · 2025 · PMID 41002740 · DOI 10.3390/diseases13090305
preclinical-animal
Europe PMC · 2025 · PMID 41088800 · DOI 10.1080/17512433.2025.2573780
human-interventional
OpenAlex · 2024 · Source ID doi:10.1093/jsxmed/qdae161.029 · DOI 10.1093/jsxmed/qdae161.029
contextual-unclassified
OpenAlex · 2024 · Source ID doi:10.1093/jsxmed/qdae001.217 · DOI 10.1093/jsxmed/qdae001.217
contextual-unclassified
governance and regulatory context
No new outcome conclusion is inferred from discovery metadata. Named accountable approval is required for governed scientific conclusions.
1 FDA structured product label record(s) were identified for this compound name in openFDA. Label presence reflects an approved product exists under that name; it is not a claim about the specific formulation, dose, or use being discussed anywhere else on this page.
No machine-proposed evidence-strength grades exist yet for this compound; all screening records are unassigned pending further review.
Bremelanotide evidence · ranking key
A tier describes the evidentiary role and design strength of a source. It is not a popularity score, proof that every conclusion is correct, or a substitute for claim-level review.
Large, well-conducted randomized trials; prespecified major outcomes; rigorous systematic reviews or meta-analyses; and major regulatory assessments.
Smaller randomized trials, strong prospective cohorts, prespecified secondary analyses, and high-quality comparative-effectiveness studies.
Retrospective cohorts, claims-database studies, pharmacovigilance analyses, mechanistic human research, and well-documented case series.
Case reports, conference abstracts, preclinical research, hypothesis-generating analyses, and expert commentary.
APA
World Peptide Foundation. (n.d.). Bremelanotide — Peptide Scientific Intelligence. World Peptide Foundation. (Updated September 23, 2026.) https://www.worldpeptidefoundation.org/directory/bremelanotide
AMA / Vancouver
World Peptide Foundation. Bremelanotide — Peptide Scientific Intelligence. World Peptide Foundation website. Updated September 23, 2026. https://www.worldpeptidefoundation.org/directory/bremelanotide
Featured tiered studies
0
Cornerstone publications with study-level interpretation, limitations, and tier disclosure.
Research domains
6
Clinical and scientific questions synthesized independently across the evidence atlas.
Governed reviewed evidence
30
Database records promoted through the governed publication workflow—not the corpus total.
Corpus generated 2026-09-18. Counts remain separately labeled to prevent automated screening from being represented as completed human review.
Human experience · separate evidence stream
Eligible observations remain below the privacy and reliability threshold. WPF will not convert a handful of reports into a percentage, trend, or clinical claim.
Observation is valuable human context. It is not evidence of causation, efficacy, or safety.
Public display gate
n ≥ 20 eligible observations
Exact progress remains private before the threshold.
Intelligence snapshot
A compact view of what is represented, what remains unresolved, and how completely the record can be traced.
Ranked research corpus
181
Categorized screening records; proposed rankings remain pending human appraisal.
Featured tiered studies
0
Cornerstone studies with published study-level interpretation and tier disclosure.
Research domains
6
Independent evidence dossiers covering the major research questions.
Governed reviewed evidence
30
Reviewed database records promoted through the governed publication workflow.
Contradictions
0
Conflicting evidence relationships that remain visible.
Research gaps
1
Questions the current record identifies as unresolved.
Connected media
0
Media records explicitly linked to this scientific record.
What we know
The project separates represented evidence from qualification, contradiction, uncertainty, and what the evidence does not establish.
Reconciled domain conclusions
Bremelanotide no longer relies on the legacy “no public claim” state. Each research domain publishes a bounded conclusion, confidence level, evidence synthesis, limitations, geographic applicability, regulatory interpretation, and research gaps.
Inspect the reconciled evidence atlasContent-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
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
Scientific context
Existing reviewed chemistry is preserved as scientific context. Chemistry and mechanism information do not establish clinical efficacy or safety.
Chemical identity describes the recorded molecular information. It does not establish biological activity, clinical efficacy, safety, or therapeutic suitability.
Explore further
Move from this peptide record into the project's broader evidence, research, comparison, and methodology systems.
Research
Chronology, unresolved research questions, opportunities, and researcher activity remain descriptive rather than evaluative.
2004 · study · Temporal status not established
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2026 · regulatory · Temporal status not established
European Union — EMA
2026 · regulatory · Temporal status not established
United States — FDA
The represented chronology reflects records currently included in the governed dataset and does not claim to represent the entire scientific literature.
No institutional claim record is currently represented for this peptide.
Evidence is missing or not represented as studied; this is not a conclusion that the intervention does not work.
Connections
Connections appear only when they are represented by the project’s underlying records.
institution
institution
institution
Traceability
The experience makes incomplete links visible instead of presenting a false impression of perfect provenance.
Source publication state
A governed source may be verified and approved for publication while its claim-to-evidence link is still incomplete.
Reviewer provenance state
“Human scientist reviewed: no” means that specific source-path attribution is not recorded. It does not silently negate the separate publication-review state.
Domain conclusion → Evidence
Connected
Evidence → Source
Connected
Source → Original record
Connected
Traceability documents how the project connects statements to records. It does not establish that a source is scientifically valid or that a claim is clinically true.
Reconciled for 6 domain conclusions and 0 featured studies.
Detailed study-to-domain mappings and original-source paths appear in the Bremelanotide evidence-governance section.
Inspect the ranked source recordsObservational archive
Observational archive data is intentionally separated from published scientific evidence.
Observational boundary
Insufficient eligible observations are available for display under the current filters.
Insufficient eligible observations are currently represented to display aggregated findings for this peptide.
Regulatory context
Regulatory status is jurisdiction-specific and time-dependent. It is presented as context, not as a recommendation for use or a substitute for scientific evidence evaluation.
European Union — EMA
Regulator: EMA
As of: 9/23/2026 · Temporal status not established
United States — FDA
Regulator: FDA
As of: 9/23/2026 · Temporal status not established
FDA VYLEESI (bremelanotide injection) prescribing information
Research + media
Only media explicitly linked through the project’s relationship system appears here.
No scientifically connected media is currently represented for this peptide.
Sources + provenance
Generated: 9/24/2026, 4:01:25 AM
Tier classifies source design and evidentiary role. Confidence reflects risk of bias, sample size, comparator quality, outcome relevance, follow-up, missing data, directness, replication, reporting quality, and whether conclusions stay within the measured results.
Funding and conflicts are disclosed and considered, but sponsorship never automatically changes a tier. Corrections, retractions, and expressions of concern override the original rating.
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.)
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
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
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.)
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
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 >30 kg/m 2 were studied in two phase 1, single-centre, randomized, doub
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
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
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
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®), 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
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.
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
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
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.
Content-verified record concerning Bremelanotide: "Bremelanotide: First Approval." Abstract excerpt: Bremelanotide (Vyleesi™) 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
Summarizes safety observations across the bremelanotide development program; population and study design limits apply.
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
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
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
Content-verified record concerning Bremelanotide: "Bremelanotide (Vyleesi) for hypoactive sexual desire disorder." (identity confirmed; no abstract text available to excerpt.)
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
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
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
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
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
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
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
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