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Experience 2.0

Melanocortin peptide analog

Afamelanotide

Afamelanotide is a melanocortin peptide analog. The research record considers pigmentation biology and clinical outcomes in erythropoietic protoporphyria, alongside distinct exploratory questions such as UV responses and vitiligo. These settings should be kept separate.

Record status

Traceability partial

Last meaningful update: 9/26/2026

Evidence searched through:
Not recorded
Assessment updated:
9/26/2026
Documented human review:
No documented human review recorded
Automated scientific assessment:
9/26/2026
AI source check:
9/26/2026

Published source links and profile text pass separate gates. Only a documented human review is labelled as human review; an automated scientific assessment applies deterministic checks, and an AI source check confirms only that a source exists and matches its identifiers. A source count alone does not establish a review.

Evidence coverage has three distinct layers. The corpus count is a transparent screening inventory, the featured set contains study-level tiering and interpretation, and the published-source count contains records promoted through the institutional publication workflow. Source validation, editorial publication, and scientific appraisal are separate decisions; these numbers must not be merged.

Ranked research corpus

151

Categorized publications with provisional ranking; scientific review remains separate.

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.

Published source records

45

Database records promoted through the governed publication workflow—not the corpus total.

Corpus generated 2026-09-18. Counts remain separately labeled so screening is not represented as completed review.

Human experience · separate evidence stream

No community pattern is displayed yet

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.

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n ≥ 20 eligible observations

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Intelligence snapshot

The state of the record

A compact view of what is represented, what remains unresolved, and how completely the record can be traced.

Ranked research corpus

151

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.

Published source records

45

Source records published through the governed workflow; this count does not certify scientific conclusions.

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

Evidence, claims, and boundaries

The project separates represented evidence from qualification, contradiction, uncertainty, and what the evidence does not establish.

Reconciled domain conclusions

6 published domain syntheses connected to 0 featured studies

Afamelanotide no longer relies on the legacy “no public claim” state. Each research domain publishes a bounded synthesis, confidence level, evidence context, limitations, geographic applicability, regulatory interpretation, and research gaps. Publication of these syntheses is separate from the scientific review status shown above.

Inspect the reconciled evidence atlas
Inspect the published evidence record45 governed records · titles, provenance, and original-source linksOpen records ↓
2015Phase 1–2 human evidence

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

Content-verified record concerning Afamelanotide: "Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial." Abstract excerpt: Narrowband UV-B (NB-UV-B) phototherapy is used extensively to treat vitiligo. Afamelanotide, an analogue of α-melanocyte-stimulating hormone, is known to induce tanning of the skin. To evaluate the efficacy and safety of combination therapy for generalized vitiligo consisting of afamelanotide implant and NB-UV-B phototherapy. This study was performed in 2 academic outpatient dermatology cent

Source
peer_reviewed_research
DOI
10.1001/jamadermatol.2014.1875
PubMed
25230094
Open original source
2024Observational human evidence

The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study.

Content-verified record concerning Afamelanotide: "The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study." Abstract excerpt: Patients with erythropoietic protoporphyria experience lifelong painful photosensitivity resulting in a lack of sunlight exposure. Previous studies have shown that 47-63% of patients with EPP suffer from vitamin D deficiency and a high prevalence of osteoporosis. An effective treatment for EPP has been available since 2016: the α-melanocyte stimulating hormone analogue afamelanotide. So far,

Source
peer_reviewed_research
DOI
10.1093/bjd/ljae148
PubMed
38634774
Open original source
2010Observational human evidence

Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria.

Content-verified record concerning Afamelanotide: "Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria." Abstract excerpt: Afamelanotide, an α-melanocyte stimulating hormone (MSH) agonistic analog is a first-in-class therapeutic. Its application to protoporphyria (PP), a disease associated with absolute sunlight-intolerance is discussed. The genetics and existing therapy of the inherited disease PP comprising both erythropoietic protoporphyria and X-linked dominant protoporphyria. The physiological and pharmacol

Source
peer_reviewed_research
DOI
10.1517/13543784.2010.535515
PubMed
21073357
Open original source
2015Observational human evidence

Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria.

Content-verified record concerning Afamelanotide: "Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria." Abstract excerpt: In erythropoietic protoporphyria (EPP), an inherited disease of porphyrin-biosynthesis, the accumulation of protoporphyrin in the skin causes severely painful phototoxic reactions. Symptom prevention was impossible until recently when afamelanotide became available. Afamelanotide-induced skin pigmentation has statistically significantly improved light-tolerance, although the clinical significance

Source
peer_reviewed_research
DOI
10.1111/bjd.13598
PubMed
25494545
Open original source
2020Observational human evidence

Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice.

Content-verified record concerning Afamelanotide: "Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice." Abstract excerpt: The effectiveness of afamelanotide treatment in patients with erythropoietic protoporphyria (EPP) in clinical practice who experience pain after light exposure that substantially impairs quality of life is unknown. To evaluate the association of afamelanotide treatment with outcomes in patients with EPP in regular practice during longer-term follow-up. This single-center, prospective postauthoriza

Source
peer_reviewed_research
DOI
10.1001/jamadermatol.2020.0352
PubMed
32186677
Open original source
2013Observational human evidence

The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo.

Content-verified record concerning Afamelanotide: "The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo." Abstract excerpt: Vitiligo is characterized by depigmented patches of skin due to loss of cutaneous melanocytes. Many recent studies have demonstrated defects in the melanocortin system in patients with vitiligo, including decreased circulating and lesional skin levels of α-melanocyte-stimulating hormone (α-MSH). Afamelanotide is a potent and longer-lasting synthetic analogue of naturally occurring &#x3

Source
peer_reviewed_research
DOI
10.1001/2013.jamadermatol.386
PubMed
23407924
Open original source
2026Observational human evidence

Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients.

Content-verified record concerning Afamelanotide: "Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients." Abstract excerpt: Erythropoietic protoporphyria (EPP) is a rare genetic disorder characterized by severe phototoxic reactions that occur within minutes of light exposure. In clinical studies, afamelanotide has been shown to prolong pain-free sun exposure, improve quality of life, and reduce the frequency and severity of phototoxic reactions. To present the real-world data of the Austrian EPP cohort treated with afa

Source
peer_reviewed_research
DOI
10.1111/ddg.15996
PubMed
41793078
Open original source
2011Observational human evidence

Pseudoleucoderma after injections of afamelanotide in a patient with atopic dermatitis.

Content-verified record concerning Afamelanotide: "Pseudoleucoderma after injections of afamelanotide in a patient with atopic dermatitis." (identity confirmed; no abstract text available to excerpt.)

Source
peer_reviewed_research
DOI
10.2340/00015555-1062
PubMed
21597671
Open original source
2023Observational human evidence

Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study.

Content-verified record concerning Afamelanotide: "Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study." (identity confirmed; no abstract text available to excerpt.)

Source
peer_reviewed_research
DOI
10.1016/j.jaad.2022.10.012
PubMed
36244556
Open original source
2024Observational human evidence

Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort.

Content-verified record concerning Afamelanotide: "Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort." Abstract excerpt: Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) are rare disorders of heme biosynthesis characterized by severe cutaneous phototoxicity. Afamelanotide, an α-melanocyte-stimulating hormone analogue, is the only approved treatment for protoporphyria and leads to increased light tolerance and improved quality of life (QoL). However, published experience with afamelanotide

Source
peer_reviewed_research
DOI
10.3390/life14060689
PubMed
38929673
Open original source
2023Observational human evidence

Erythropoietic protoporphyria in the Netherlands: Clinical features, psychosocial impact and the effect of afamelanotide.

Content-verified record concerning Afamelanotide: "Erythropoietic protoporphyria in the Netherlands: Clinical features, psychosocial impact and the effect of afamelanotide." Abstract excerpt: Erythropoietic protoporphyria (EPP) patients experience severe burning pain after light exposure, which results in a markedly reduced quality of life. However, there is limited information on the psychosocial aspects of EPP. To investigate the clinical features and social aspects of living with EPP, before and during afamelanotide treatment in the Netherlands. A single-center prospective longitudi

Source
peer_reviewed_research
DOI
10.1111/1346-8138.16690
PubMed
36579412
Open original source
2020Animal research

[Medicaments and oral healthcare. Hyperpigmentation of oral soft tissues due to afamelanotide].

Content-verified record concerning Afamelanotide: "[Medicaments and oral healthcare. Hyperpigmentation of oral soft tissues due to afamelanotide]." Abstract excerpt: The medicament afamelanotide is an analogue of endogenous ?-melanocyte-stimulating hormone. It promotes cutaneous pigmentation, providing protection from sunlight. In dermatology, afamelanotide seems to establish therapeutic results for polymorphic light eruption, solar urticaria, erythropoietic protoporphyria, Hailey-Hailey disease, vitiligo and acne vulgaris. Afamelanotide is available for non-m

Source
peer_reviewed_research
DOI
10.5177/ntvt.2020.04.19115
PubMed
32459219
Open original source
2012Animal research

Afamelanotide

Content-verified record concerning Afamelanotide: "Afamelanotide" Abstract excerpt: Afamelanotide is a melanocortin-1 receptor agonist that stimulates melanin production in the skin and is used to decrease pain and itching from light exposure in patients with erythropoietic protoporphyria and X-linked protoporphyria. Afamelanotide has not been linked to serum aminotransferase elevations during therapy nor to instances of idiosyncratic acute liver injury with symptoms and jaundice

Source
other
PubMed
38598652
Open original source
2026Animal research

Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide.

Content-verified record concerning Afamelanotide: "Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide." Abstract excerpt: Afamelanotide, also known as melanotan-1, is a synthetic 13-amino acid peptidomimetic of α-melanocyte stimulating hormone (α-MSH), and is a critical peptide orphan drug used for the management of erythropoietic protoporphyria. It contains norleucine and D-phenylalanine at positions 4 and 7, in place of methionine and L-phenylalanine, respectively as found in endogenous peptide. Therape

Source
peer_reviewed_research
DOI
10.1016/j.jpba.2026.117362
PubMed
41547183
Open original source
2013Animal research

A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyria.

Content-verified record concerning Afamelanotide: "A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyria." Abstract excerpt: The tridecapeptide afamelanotide (Scenesse®) is a congener of α-melanocyte stimulating hormone (α-MSH). Upon binding to the melanocortin 1 receptor (MC1R) on the surface of pigment cells of the skin, the melanocytes, α-MSH or afamelanotide trigger the synthesis of cAMP, which stimulates the synthesis of melanin and therefore induces skin tanning. In a recent trial, afamelano

Source
peer_reviewed_research
DOI
10.1016/j.jpba.2012.11.040
PubMed
23277150
Open original source
2017Animal research

Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders.

Content-verified record concerning Afamelanotide: "Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders." Abstract excerpt: Afamelanotide, the first α-melanocyte-stimulating hormone (MSH) analogue, synthesized in 1980, was broadly investigated in all aspects of pigmentation because its activity and stability were higher than the natural hormone. Afamelanotide binds to the melanocortin-1 receptor (MC1R), and MC1R signaling increases melanin synthesis, induces antioxidant activities, enhances DNA repair processes a

Source
peer_reviewed_research
DOI
10.1007/s40262-016-0501-5
PubMed
28063031
Open original source
2026Animal research

Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study.

Exploratory human study of acute UV response; not evidence of benefit across other conditions.

Source
peer_reviewed_research
DOI
10.1007/s43630-026-00986-x
PubMed
42678656
Open original source
2015Insufficient evidence

Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria.

Content-verified record concerning Afamelanotide: "Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria." Abstract excerpt: The application of afamelanotide, an α-melanocyte stimulating hormone agonistic analogue to protoporphyria, a disease with absolute sunlight-intolerance is discussed. The clinics, genetics and existing therapies of protoporphyria are described. The physiological receptor-mediated intracellular signaling of α-melanocyte stimulating hormone and effects of receptor variants are outlined.

Source
peer_reviewed_research
DOI
10.1586/17512433.2014.956089
PubMed
25470471
Open original source
2024Insufficient evidence

Afamelanotide in protoporphyria and other skin diseases: a review.

Content-verified record concerning Afamelanotide: "Afamelanotide in protoporphyria and other skin diseases: a review." Abstract excerpt: Afamelanotide is a synthetic alpha melanocyte stimulating hormone presenting a higher activity than natural hormones. Its main properties are related to the enhanced production of eumelanin by agonistically binding to the melanocortin-1 receptor. Since 2016 afamelanotide has been especially applied to treat cases of erythropoietic porphyria (EPP), where painful photosensitivity has been observed s

Source
systematic_review_or_meta_analysis
DOI
10.5114/ada.2024.138818
PubMed
38784937
Open original source
2023Insufficient evidence

Into the Light: Afamelanotide and the Treatment of Erythropoietic Protoporphyria in the United States.

Content-verified record concerning Afamelanotide: "Into the Light: Afamelanotide and the Treatment of Erythropoietic Protoporphyria in the United States." Abstract excerpt: Erythropoietic protoporphyria (EPP) is a rare disease that causes disabling cutaneous photosensitivity with pain and burning sensations. In 2019, afamelanotide, an α-melanocyte-stimulating hormone analogue, was approved in the United States for treatment of EPP. In this study, patients receiving afamelanotide filled out questionnaires assessing the benefit of treatment. Outcomes measured inc

Source
peer_reviewed_research
DOI
10.36849/jdd.7126
PubMed
37683058
Open original source
2023Insufficient evidence

A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial.

Content-verified record concerning Afamelanotide: "A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial." Abstract excerpt: Neuroprotective agents have the potential to improve the outcomes of revascularisation therapies in acute ischemic stroke patients (AIS) and in those unable to receive revascularisation. Afamelanotide, a synthetic α-melanocyte stimulating hormone analogue, is a potential novel neuroprotective agent. We set out to assess the feasibility and safety of afamelanotide for the first time in AIS pa

Source
peer_reviewed_research
DOI
10.1186/s12883-023-03338-9
PubMed
37496004
Open original source
2013Insufficient evidence

A review and update on melanocyte stimulating hormone therapy: afamelanotide.

Content-verified record concerning Afamelanotide: "A review and update on melanocyte stimulating hormone therapy: afamelanotide." Abstract excerpt: Afamelanotide ([Nle4-D-Phe7]-alpha-MSH) is an analog of alpha-melanocyte stimulating hormone given as a subcutaneous injection. Afamelanotide is currently undergoing phase II and III trials in Europe and the US for skin diseases including vitiligo, erythropoietic protoporphyria, polymorphic light eruption and prevention of actinic keratoses in organ transplant recipients. Unregulated analogs and c

Source
peer_reviewed_research
PubMed
23884489
Open original source
2015Insufficient evidence

Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies.

Content-verified record concerning Afamelanotide: "Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies." Abstract excerpt: Afamelanotide is an α-melanocyte-stimulating hormone (α-MSH) agonist with proven efficacy in photodermatoses such as erythropoietic protoporphyria (EPP). This peptide drug, repeatedly administered over prolonged time, may induce anti-drug antibodies (ADA). Here, we describe a new ELISA method developed to monitor the occurrence of ADA against afamelanotide as well as against α-MS

Source
peer_reviewed_research
DOI
10.1159/000362174
PubMed
25402764
Open original source
2025Insufficient evidence

German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP).

Content-verified record concerning Afamelanotide: "German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP)." Abstract excerpt: Afamelanotide 16 mg (SCENESSE) is the first approved treatment for erythropoietic protoporphyria (EPP). EPP is a rare autosomal recessive inherited disorder of the haem biosynthesis pathway, where patients experience severe and debilitating acute phototoxicity. It affects at least one in 140,000 of the European population. A postauthorisation safety study (PASS) and a disease registry were imposed

Source
peer_reviewed_research
DOI
10.1111/phpp.13012
PubMed
40082741
Open original source
2020Insufficient evidence

Increased phototoxic burn tolerance time and quality of life in patients with erythropoietic protoporphyria treated with afamelanotide - a three years observational study.

Content-verified record concerning Afamelanotide: "Increased phototoxic burn tolerance time and quality of life in patients with erythropoietic protoporphyria treated with afamelanotide - a three years observational study." Abstract excerpt: Erythropoietic protoporphyria (EPP) is an ultra-rare genetic disorder (prevalence 1:150`000) characterized by instant painful phototoxic burn reactions in skin exposed to visible light. Afamelanotide is the first clinically tested therapy effectively increasing the time EPP patients can spend in direct sunlight without developing symptoms and reducing the number and severity of phototoxic reaction

Source
peer_reviewed_research
DOI
10.1186/s13023-020-01505-6
PubMed
32811524
Open original source
2020Insufficient evidence

Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians.

Content-verified record concerning Afamelanotide: "Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians." (identity confirmed; no abstract text available to excerpt.)

Source
peer_reviewed_research
DOI
10.1016/j.jaad.2020.01.035
PubMed
31987791
Open original source
2024Insufficient evidence

Erythropoietic protoporphyria and afamelanotide: a patient's perspective.

Content-verified record concerning Afamelanotide: "Erythropoietic protoporphyria and afamelanotide: a patient's perspective." (identity confirmed; no abstract text available to excerpt.)

Source
peer_reviewed_research
DOI
10.1093/ced/llad346
PubMed
37831089
Open original source
2021Insufficient evidence

Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria.

Content-verified record concerning Afamelanotide: "Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria." Abstract excerpt: Introduction : In erythropoietic protoporphyria (EPP), an inherited disorder of heme biosynthesis, accumulation of protoporphyrin IX results in acute phototoxicity. EPP patients experience severe burning pain after light exposure, which results in a markedly reduced quality of life. Afamelanotide is the first effective approved medical treatment for EPP, acting on melanocortin-1 receptors. This ar

Source
peer_reviewed_research
DOI
10.1080/17512433.2021.1879638
PubMed
33507118
Open original source
2021Insufficient evidence

Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide.

Content-verified record concerning Afamelanotide: "Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide." Abstract excerpt: Afamelanotide (AFA) is a synthetic analogue of α-melanocyte-stimulating hormone that is approved for the treatment of patients affected by erythropoietic protoporphyria (EPP). AFA induces a "sun free" tanning and changes of acquired melanocytic nevi (AMN) that are generically described as "darkening". To assess clinical and dermoscopic AMN changes during AFA treatment. Adult EPP patients tre

Source
peer_reviewed_research
DOI
10.1007/s43630-021-00020-2
PubMed
33721252
Open original source
2021Insufficient evidence

Afamelanotide: An Orphan Drug with Potential for Broad Dermatologic Applications.

Content-verified record concerning Afamelanotide: "Afamelanotide: An Orphan Drug with Potential for Broad Dermatologic Applications." Abstract excerpt: Afamelanotide (SCENESSE®) is a synthetic analogue of α-melanocyte-stimulating hormone that is FDA-approved to increase pain-free sunlight exposure in adult patients with erythropoietic protoporphyria. Its dual photoprotective and anti-inflammatory effects also make it a promising therapy for other photosensitive dermatologic diseases that are resistant to treatment. The PubMed/MEDLINE an

Source
peer_reviewed_research
DOI
10.36849/jdd.5526
PubMed
33683075
Open original source
2016Insufficient evidence

Afamelanotide: A Review in Erythropoietic Protoporphyria.

Content-verified record concerning Afamelanotide: "Afamelanotide: A Review in Erythropoietic Protoporphyria." Abstract excerpt: Afamelanotide (SCENESSE(®)) is a synthetic α-melanocyte stimulating hormone analogue and first-in-class melanocortin-1 receptor agonist that is approved in the EU for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP). It is administered subcutaneously as a biodegradable, controlled-release implant containing 16 mg of afamelanotide. This article revi

Source
peer_reviewed_research
DOI
10.1007/s40257-016-0184-6
PubMed
26979527
Open original source
2024Insufficient evidence

Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide.

Content-verified record concerning Afamelanotide: "Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide." (identity confirmed; no abstract text available to excerpt.)

Source
peer_reviewed_research
DOI
10.1093/bjd/ljae191
PubMed
38736212
Open original source
Insufficient evidence

From darkness to light: Case report on afamelanotide-treatment in a 9-year-old child with erythropoietic protoporphyria.

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1016/j.jdcr.2025.11.022
PubMed
41542313
Open original source
Insufficient evidence

Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1093/ced/llaf306
PubMed
40692281
Open original source
Insufficient evidence

EMA , It's Time to Reconsider! 10 Years Afamelanotide for Treating Erythropoietic Protoporphyria

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1111/phpp.70039
Open original source
Insufficient evidence

461 The effects of afamelanotide on UVR-induced DNA damage, acute inflammatory and DNA repair responses in human skin

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1016/j.jid.2024.10.472
Open original source
Insufficient evidence

PD05 The effects of afamelanotide on ultraviolet radiation-induced acute inflammatory and DNA repair responses in healthy human skin

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1093/bjd/ljae090.169
Open original source
Insufficient evidence

04111 Phlebotomy and afamelanotide as an efficient combined treatment of hepatoerythropoietic porphyria

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1136/bmjgast-2024-icpp.15
Open original source
Insufficient evidence

04121 Afamelanotide for the treatment of cutaneous phototoxicity of erythropoietic protoporphyria: the Scottish experience

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1136/bmjgast-2024-icpp.33
Open original source
Insufficient evidence

PD03 Afamelanotide reduces the ultraviolet radiation erythemal response soon after application in healthy volunteers with skin phototypes II–III

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1093/bjd/ljad113.341
Open original source
Insufficient evidence

Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.3390/life13041066
PubMed
37109595
Open original source
Insufficient evidence

Clinical Experience with Afamelanotide for the Protoporphyrias in the United States

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.1182/blood-2022-163566
Open original source
Insufficient evidence

A Feasibility and Safety Study of Afamelanotide in Acute Stroke Patients – An Open Label, Proof of Concept, Phase Iia Clinical Trial

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.21203/rs.3.rs-2306958/v1
Open original source
Insufficient evidence

Cryo-EM structure of afamelanotide-MC4R-Gs_Nb35 complex

Source reference associated with Afamelanotide. Source identity and peptide connection confirmed; scientific conclusions and evidence strength have not been assessed in this source-linking step.

Source
other
DOI
10.2210/pdb7f54/pdb
Open original source
2015Insufficient evidence

Afamelanotide for Erythropoietic Protoporphyria.

Content-verified record concerning Afamelanotide: "Afamelanotide for Erythropoietic Protoporphyria." Abstract excerpt: Erythropoietic protoporphyria is a severe photodermatosis that is associated with acute phototoxicity. Patients with this condition have excruciating pain and a markedly reduced quality of life. We evaluated the safety and efficacy of an α-melanocyte-stimulating hormone analogue, afamelanotide, to decrease pain and improve quality of life. We conducted two multicenter, randomized, double-bli

Source
peer_reviewed_research
DOI
10.1056/nejmoa1411481
PubMed
26132941
Open original source

Scientific context

Chemistry and represented biological context

Existing reviewed chemistry is preserved as scientific context. Chemistry and mechanism information do not establish clinical efficacy or safety.

Open chemistry and biological context ↓
Chemical identity

Molecular and structural record

Structured record
Molecular formula
C78H111N21O19
Molecular weight (Da)
1646.8
SMILES
CCCCC(C(=O)NC(CCC(=O)O)C(=O)NC(CC1=CN=CN1)C(=O)NC(CC2=CC=CC=C2)C(=O)NC(CCCNC(=N)N)C(=O)NC(CC3=CNC4=CC=CC=C43)C(=O)NCC(=O)NC(CCCCN)C(=O)N5CCCC5C(=O)NC(C(C)C)C(=O)N)NC(=O)C(CO)NC(=O)C(CC6=CC=C(C=C6)O)NC(=O)C(CO)NC(=O)C
InChI
InChI=1S/C78H111N21O19/c1-5-6-19-52(91-75(116)61(41-101)97-72(113)57(34-46-24-26-49(103)27-25-46)94-74(115)60(40-100)88-44(4)102)68(109)92-54(28-29-64(105)106)70(111)96-59(36-48-38-83-42-87-48)73(114)93-56(33-45-16-8-7-9-17-45)71(112)90-53(22-14-31-84-78(81)82)69(110)95-58(35-47-37-85-51-20-11-10-18-50(47)51)67(108)86-39-63(104)89-55(21-12-13-30-79)77(118)99-32-15-23-62(99)76(117)98-65(43(2)3)66(80)107/h7-11,16-18,20,24-27,37-38,42-43,52-62,65,85,100-101,103H,5-6,12-15,19,21-23,28-36,39-41,79H2,1-4H3,(H2,80,107)(H,83,87)(H,86,108)(H,88,102)(H,89,104)(H,90,112)(H,91,116)(H,92,109)(H,93,114)(H,94,115)(H,95,110)(H,96,111)(H,97,113)(H,98,117)(H,105,106)(H4,81,82,84)/t52-,53-,54-,55-,56+,57-,58-,59-,60-,61-,62-,65-/m0/s1
InChIKey
UAHFGYDRQSXQEB-LEBBXHLNSA-N

Chemical identity describes the recorded molecular information. It does not establish biological activity, clinical efficacy, safety, or therapeutic suitability.

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Methodology

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Research

How the scientific record is developing

Chronology, unresolved research questions, opportunities, and researcher activity remain descriptive rather than evaluative.

Research chronology

  1. 2010 · study · Temporal status not established

    Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria.

    peer_reviewed_research

  2. 2011 · study · Temporal status not established

    Pseudoleucoderma after injections of afamelanotide in a patient with atopic dermatitis.

    peer_reviewed_research

  3. 2012 · study · Temporal status not established

    Afamelanotide

    other

  4. 2013 · study · Temporal status not established

    The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo.

    peer_reviewed_research

  5. 2013 · study · Temporal status not established

    A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyria.

    peer_reviewed_research

  6. 2013 · study · Temporal status not established

    A review and update on melanocyte stimulating hormone therapy: afamelanotide.

    peer_reviewed_research

  7. 2015 · study · Temporal status not established

    Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

    peer_reviewed_research

  8. 2015 · study · Temporal status not established

    Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria.

    peer_reviewed_research

  9. 2015 · study · Temporal status not established

    Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria.

    peer_reviewed_research

  10. 2015 · study · Temporal status not established

    Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies.

    peer_reviewed_research

  11. 2015 · study · Temporal status not established

    Afamelanotide for Erythropoietic Protoporphyria.

    peer_reviewed_research

  12. 2016 · study · Temporal status not established

    Afamelanotide: A Review in Erythropoietic Protoporphyria.

    peer_reviewed_research

  13. 2017 · study · Temporal status not established

    Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders.

    peer_reviewed_research

  14. 2020 · study · Temporal status not established

    Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice.

    peer_reviewed_research

  15. 2020 · study · Temporal status not established

    [Medicaments and oral healthcare. Hyperpigmentation of oral soft tissues due to afamelanotide].

    peer_reviewed_research

  16. 2020 · study · Temporal status not established

    Increased phototoxic burn tolerance time and quality of life in patients with erythropoietic protoporphyria treated with afamelanotide - a three years observational study.

    peer_reviewed_research

  17. 2020 · study · Temporal status not established

    Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians.

    peer_reviewed_research

  18. 2021 · study · Temporal status not established

    Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria.

    peer_reviewed_research

  19. 2021 · study · Temporal status not established

    Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide.

    peer_reviewed_research

  20. 2021 · study · Temporal status not established

    Afamelanotide: An Orphan Drug with Potential for Broad Dermatologic Applications.

    peer_reviewed_research

  21. 2023 · study · Temporal status not established

    Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study.

    peer_reviewed_research

  22. 2023 · study · Temporal status not established

    Erythropoietic protoporphyria in the Netherlands: Clinical features, psychosocial impact and the effect of afamelanotide.

    peer_reviewed_research

  23. 2023 · study · Temporal status not established

    Into the Light: Afamelanotide and the Treatment of Erythropoietic Protoporphyria in the United States.

    peer_reviewed_research

  24. 2023 · study · Temporal status not established

    A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial.

    peer_reviewed_research

  25. 2024 · study · Temporal status not established

    The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study.

    peer_reviewed_research

  26. 2024 · study · Temporal status not established

    Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort.

    peer_reviewed_research

  27. 2024 · study · Temporal status not established

    Afamelanotide in protoporphyria and other skin diseases: a review.

    systematic_review_or_meta_analysis

  28. 2024 · study · Temporal status not established

    Erythropoietic protoporphyria and afamelanotide: a patient's perspective.

    peer_reviewed_research

  29. 2024 · study · Temporal status not established

    Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide.

    peer_reviewed_research

  30. 2025 · study · Temporal status not established

    German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP).

    peer_reviewed_research

  31. 2026 · study · Temporal status not established

    Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients.

    peer_reviewed_research

  32. 2026 · study · Temporal status not established

    Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide.

    peer_reviewed_research

  33. 2026 · study · Temporal status not established

    Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study.

    peer_reviewed_research

  34. 2026 · regulatory · Temporal status not established

    Regulatory review: approved

    European Union — EMA

  35. 2026 · regulatory · Temporal status not established

    Regulatory review: approved

    United States — FDA

  36. Date unavailable · study · Temporal status not established

    From darkness to light: Case report on afamelanotide-treatment in a 9-year-old child with erythropoietic protoporphyria.

    other

  37. Date unavailable · study · Temporal status not established

    Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.

    other

  38. Date unavailable · study · Temporal status not established

    EMA , It's Time to Reconsider! 10 Years Afamelanotide for Treating Erythropoietic Protoporphyria

    other

  39. Date unavailable · study · Temporal status not established

    461 The effects of afamelanotide on UVR-induced DNA damage, acute inflammatory and DNA repair responses in human skin

    other

  40. Date unavailable · study · Temporal status not established

    PD05 The effects of afamelanotide on ultraviolet radiation-induced acute inflammatory and DNA repair responses in healthy human skin

    other

  41. Date unavailable · study · Temporal status not established

    04111 Phlebotomy and afamelanotide as an efficient combined treatment of hepatoerythropoietic porphyria

    other

  42. Date unavailable · study · Temporal status not established

    04121 Afamelanotide for the treatment of cutaneous phototoxicity of erythropoietic protoporphyria: the Scottish experience

    other

  43. Date unavailable · study · Temporal status not established

    PD03 Afamelanotide reduces the ultraviolet radiation erythemal response soon after application in healthy volunteers with skin phototypes II–III

    other

  44. Date unavailable · study · Temporal status not established

    Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.

    other

  45. Date unavailable · study · Temporal status not established

    Clinical Experience with Afamelanotide for the Protoporphyrias in the United States

    other

  46. Date unavailable · study · Temporal status not established

    A Feasibility and Safety Study of Afamelanotide in Acute Stroke Patients – An Open Label, Proof of Concept, Phase Iia Clinical Trial

    other

  47. Date unavailable · study · Temporal status not established

    Cryo-EM structure of afamelanotide-MC4R-Gs_Nb35 complex

    other

The represented chronology reflects records currently included in the governed dataset and does not claim to represent the entire scientific literature.

What still needs investigation

Claim traceability

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

Follow the scientific relationships

Connections appear only when they are represented by the project’s underlying records.

Open 3 represented connections ↓

institution

peer_reviewed_research

represented evidence source

institution

other

represented evidence source

institution

systematic_review_or_meta_analysis

represented evidence source

Traceability

Follow the record back to its source

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 Afamelanotide evidence-governance section.

Inspect the ranked source records

Observational archive

What contributors reported

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

Published jurisdictional records

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.

Research + media

Media connected to this scientific record

Only media explicitly linked through the project’s relationship system appears here.

No scientifically connected media is currently represented for this peptide.

Sources + provenance

Read the scientific record with its boundaries intact

The public record organizes reviewed evidence; it does not establish scientific truth by itself.
Association, mechanism, observation and regulatory status must not be represented as proof of clinical efficacy or safety.
Observational reports describe contributor experiences and cannot establish causation, effectiveness, safety or clinical benefit.
Contradictory and qualifying evidence must remain visible rather than being silently discarded.
Absence of represented evidence is not evidence that research does not exist.
Research gaps identify unresolved questions; they are not negative conclusions.
Regulatory status is distinct from scientific evidence quality.
Media relationships provide context and explanation; they do not increase the strength of scientific evidence.
A section with no represented records is an incomplete project record, not a scientific conclusion.
Researcher and institutional relationships are shown only when supported by represented records and must not be interpreted as rankings or endorsements.

Generated: 11/8/2026, 5:28:47 PM

global evidence atlas

Afamelanotide research, ranked and separated by purpose

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.

151Discoverable source universe
151Ranked screening records
6Research domains
0Accountably approved conclusions

151 matching records · ranked 2026-09-18

Page 1 of 7

#4Proposed tier Unassignedcontextual unclassifiedAwaiting human appraisal

Afamelanotide

OpenAlex · 2026 · Source ID doi:10.1007/s40278-026-93209-0 · DOI 10.1007/s40278-026-93209-0

contextual-unclassified

Count reconciliation: 151 discoverable source records match the peptide identity query; 151 are retained in this bounded, ranked screening view; 0 belong to the separate governed layer labeled “Accountably approved conclusions.” Domain totals overlap because one publication may inform several questions.

governance and regulatory context

Afamelanotide: what this atlas does and does not establish

Last checked
2026-09-18
Accountable publication approval
Not yet approved by a named accountable reviewer. Machine screening only.

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.

Afamelanotide evidence · ranking key

How evidence is ranked

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.

A

Practice-defining evidence

Large, well-conducted randomized trials; prespecified major outcomes; rigorous systematic reviews or meta-analyses; and major regulatory assessments.

B

Strong supporting evidence

Smaller randomized trials, strong prospective cohorts, prespecified secondary analyses, and high-quality comparative-effectiveness studies.

C

Contextual evidence

Retrospective cohorts, claims-database studies, pharmacovigilance analyses, mechanistic human research, and well-documented case series.

D

Signal-generating evidence

Case reports, conference abstracts, preclinical research, hypothesis-generating analyses, and expert commentary.

Tier and confidence answer different questions

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.

Suggested citation

  • APA

    World Peptide Foundation. (n.d.). Afamelanotide — Peptide Scientific Intelligence. World Peptide Foundation. (Updated September 26, 2026.) https://www.worldpeptidefoundation.org/directory/afamelanotide

  • AMA / Vancouver

    World Peptide Foundation. Afamelanotide — Peptide Scientific Intelligence. World Peptide Foundation website. Updated September 26, 2026. https://www.worldpeptidefoundation.org/directory/afamelanotide