U.S. label recordDermatology

Afamelanotide

Related names in cited records: Scenesse

A melanocortin analogue. This profile cites a U.S. label record.

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Afamelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed September 15, 2026 · Review version 1.

Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.

Four selected reports cover randomized trials in erythropoietic protoporphyria (EPP), an observational EPP cohort, combination treatment in vitiligo, and an exploratory stroke study. This is a selected overview, not a completed systematic review.

What the reviewed sources report

The EPP trials reported longer pain-free sunlight exposure. Evidence in vitiligo concerns combination treatment with phototherapy; the six-person stroke study cannot establish treatment benefit or safety. Results from these different settings should not be pooled.

What remains unresolved?

  • How durable are benefits and harms in broader EPP populations, including those underrepresented in the trials?
  • What do controlled studies establish in indications beyond EPP, and how do combination treatments affect attribution?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Scenesse · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited implant label covers increased pain-free light exposure in adults with erythropoietic protoporphyria and a history of phototoxic reactions. This is not a general tanning or cosmetic indication. Label: indications and usage ↗

Which safety limits matter?

The label contraindicates severe hypersensitivity and reports postmarketing anaphylaxis. It also describes increased pigmentation and darkening of existing skin lesions, with skin monitoring addressed in the warnings. Label: contraindications, warnings and precautions ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

SCENESSE (afamelanotide) implant · SPL version 11 · published 2026-05-13

Label ZIP SHA-256: 2524c0069e687a8d327718fa17678071dd3c817a42624f569870344888f34e29. Extracted XML SHA-256: d58fc4df343aa1a49a633ed2fbfb46eb5cc94ec6d9e059a4e1d86d4dd1f43397.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Inside the official reviews

Reviewed 2026-09-16 · Preserved version 1

What did FDA find beyond the headline result?

FDA’s 2019 review supported approval for increased pain-free light exposure in adults with erythropoietic protoporphyria. In CUV039, the sponsor’s analysis gave p=0.044; FDA’s analysis including missing-data assumptions gave p=0.055. FDA considered CUV029 supportive, while CUV030’s pain-free exposure analysis was post hoc. FDA PDF pp. 19, 20, 118 ↗

More findings, study links and document coverage

Which limitations affect interpretation?

FDA described diary-design and data-handling problems, different exposure windows and follow-up periods, and uncertainty about the quality-of-life instruments. Twenty-six participants from CUV030 could re-enroll in CUV039, so the trial enrollment totals do not represent entirely distinct people. FDA PDF pp. 21, 117, 118, 119 ↗

What safety work was requested?

The 2019 review requested a cardiac-repolarization study and a long-term registry addressing skin cancer, implant reactions, pregnancy and device issues. These were surveillance questions, not proof that the medicine caused those outcomes. Their current completion status has not been verified in this review. FDA PDF pp. 144, 147, 148 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Matched study identities

Protocol identifiers were matched to ClinicalTrials.gov records. This does not count extensions as new independent trials.

Document coverage

Selected sections read in 1 of 16 inventoried documents; 15 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

English PDF entries containing Scenesse in the title in the retained September 15 EMA document-feed snapshot, plus selected FDA approval-package documents. Includes candidate associations, not a complete FDA inventory, national authorizations or worldwide coverage. Live EMA page requests returned HTTP 429 on September 16; fresh page reconciliation is pending. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

Remaining work

  • Review the remaining EMA assessment, product-information, risk-management and change documents; reconcile historical applications separately.
  • Reconcile later FDA supplements and current postmarketing-study status. Earlier review conclusions are dated evidence, not a current approval-status substitute.
  • Complete full-text and correction appraisal of the related literature. Registry identity matching does not establish that all posted results or historical registry versions have been reviewed.

Open versioned document coverage and study pins →

European medicine records · 1 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

296 retrieved · 4 included · 0 excluded · 292 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Afamelanotide"[Title/Abstract] OR "NDP-MSH"[Title/Abstract] OR "melanotan I"[Title/Abstract] OR "Scenesse"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:28.501758+00:00 · HTTP 200 · SHA-256 19a0955affa52a3b9b08466c5d6eee254609a81c576baf5d4be2facbdbac6f86.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.

Showing 25 of 296 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 40082741 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: afamelanotide-PMID40082741-registry-linkage-unresolved.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 caf4351b206f34e04bf7b15cc61df01855b2aa73803e20f217c4a3b7f04ed7dc.

  2. PubMed 37496004 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT04962503.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 731b17aa519b1df6a26947c5ca31db8b851762d0fecfa77c45625f3b1c6bf266.

  3. PubMed 26132941 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT00979745; NCT01605136.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 b94a37b2a147aaedfdcff20011049a0589c73cd3790c0e727e5e8a209b2d802f.

  4. PubMed 25230094 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01430195.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 8fb8fb22056577dddd61a9f7dcdc0f316a95df3119b1d7e59a20cfa17d4c3eaf.

  5. PubMed 42678656 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42621255 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42569625 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42394403 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 41999898 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 41890775 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 41885813 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 41854307 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 41793078 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 41766687 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 41758331 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 41718315 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 41547183 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 41542313 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 41489668 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 41466311 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 41165369 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 41118158 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 41002740 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 40858983 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 40817749 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"AFAMELANOTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:09.521847+00:00 · HTTP 200 · SHA-256 8e828d0e3d9c8098f57239ae142ff1afba35bb7eafea8c1e92829dd166470d89.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA210797 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: AFAMELANOTIDE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Afamelanotide", "Scenesse"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/002548 — include: EMA feed product Scenesse; reported status: Authorised. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

19 retrieved · 8 included · 0 excluded · 11 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Afamelanotide", "Scenesse"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 19 of 19 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 19438 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - All Authorised presentations
  2. EMA 25189 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Public assessment report
  3. EMA 41502 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Summary for the public
  4. EMA 69274 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Procedural steps taken and scientific information after authorisation
  5. EMA 38510 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Risk management plan
  6. EMA 33409 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  7. EMA 72369 — include: Document linked by EMA product number; content unappraised. Scenesse-PAM-0000291457 : EPAR - Assessment report
  8. EMA 4290 — include: Document linked by EMA product number; content unappraised. Scenesse : EPAR - Product Information
  9. EMA 14965 — not screened: Title-name match awaiting identity and document review. CHMP summary of positive opinion for Scenesse
  10. EMA 17497 — not screened: Title-name match awaiting identity and document review. Scenesse recommended for rare disease that causes intolerance to sunlight
  11. EMA 22343 — not screened: Title-name match awaiting identity and document review. EU/3/09/648: Public summary of positive opinion for orphan designation of afamelanotide for the treatment of solar urticaria
  12. EMA 37594 — not screened: Title-name match awaiting identity and document review. Recommendation for maintenance of orphan designation at the time of marketing authorisation: Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria
  13. EMA 41718 — not screened: Title-name match awaiting identity and document review. EU/3/14/1285: Public summary of opinion on orphan designation: Afamelanotide for the treatment of familial benign chronic pemphigus (Hailey-Hailey disease)
  14. EMA 63429 — not screened: Title-name match awaiting identity and document review. Withdrawal letter: Scenesse
  15. EMA 64302 — not screened: Title-name match awaiting identity and document review. P/0101/2024 : EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for afamelanotide (Scenesse), (EMEA-000737-PIP02-11-M03)
  16. EMA 5096 — not screened: Title-name match awaiting identity and document review. P/292/2011: EMA decision of 2 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for afamelanotide (EMEA-000737-PIP02-11)
  17. EMA 40429 — not screened: Title-name match awaiting identity and document review. P/185/2010: European Medicines Agency decision of 24 September 2010 on the granting of a product specific waiver for afamelanotide (EMEA-000737-PIP01-09)
  18. EMA 63430 — not screened: Title-name match awaiting identity and document review. Questions and answers on the withdrawal of application to change the marketing authorisation for Scenesse (afamelanotide)
  19. EMA 72863 — not screened: Title-name match awaiting identity and document review. Withdrawal assessment report for Scenesse

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

5 retrieved · 5 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Afamelanotide", "Scenesse"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 5 of 5 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/08/541 — include: EMA orphan feed identifies [Nle4, D-Phe7]-alfa-melanocyte stimulating hormone (afamelanotide); designation status: Expired. Orphan designation is not marketing authorization.
  2. EMA EU/3/24/2947 — include: EMA orphan feed identifies afamelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  3. EMA EU/3/24/2926 — include: EMA orphan feed identifies afamelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  4. EMA EU/3/09/648 — include: EMA orphan feed identifies afamelanotide; designation status: Positive. Orphan designation is not marketing authorization.
  5. EMA EU/3/14/1285 — include: EMA orphan feed identifies afamelanotide; designation status: Positive. Orphan designation is not marketing authorization.

ClinicalTrials.gov search

ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

23 retrieved · 0 included · 0 excluded · 23 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Afamelanotide" OR "Scenesse" OR "NDP-MSH"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:24:16.542336+00:00 · HTTP 200 · SHA-256 c09faf25af379fd387f0f289eed8d46f81b3f21474723e65b0a211e218e195f1.

  • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
  • Other registries, unregistered studies and additional aliases remain outside this query.

Showing 23 of 23 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT00829192 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT04578496 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT00979745 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT01430195 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT04704713 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT06388642 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT01382589 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT00859534 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT00472901 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT04525157 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT01097044 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT06109649 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT04962503 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT04425746 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT05210582 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT01605136 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT05854784 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT05370235 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT05159752 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT05368857 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT04053270 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT04943159 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT03634137 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review

Supervised synthesis

What do selected human studies report about Afamelanotide?

Manually reviewed September 15, 2026 · version 1

Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

Four selected reports cover randomized trials in erythropoietic protoporphyria (EPP), an observational EPP cohort, combination treatment in vitiligo, and an exploratory stroke study. This is a selected overview, not a completed systematic review.1234

Bottom line from this bounded source set

The EPP trials reported longer pain-free sunlight exposure. Evidence in vitiligo concerns combination treatment with phototherapy; the six-person stroke study cannot establish treatment benefit or safety. Results from these different settings should not be pooled.1234

Reviewed study record

EPP: two placebo-controlled trials in one report

Design

Two randomized, blinded trials followed participants for six or nine months.1

Population

The European trial enrolled 74 patients with EPP and the US trial enrolled 94.1

Outcomes reported

The authors reported longer pain-free sunlight exposure and improved quality of life with afamelanotide. Adverse events were mostly mild; serious events were assessed as unrelated to treatment.1

Limitations

The report contains two trials with different follow-up periods and sunlight-exposure measurements. Their numeric exposure results should not be directly compared; limited follow-up cannot resolve uncommon long-term harms.1

Reviewed study record

EPP: German post-authorization cohort

Design

An observational registry study evaluated treated patients without an untreated comparison group.2

Population

The report describes 200 patients with EPP in the German post-authorization safety study.2

Outcomes reported

Quality-of-life scores improved relative to baseline, and 91% continued treatment at the reported cutoff. The study also collected treatment-emergent adverse events.2

Limitations

Without an untreated comparator, changes cannot establish a causal treatment effect. Treatment continuation is not proof of safety, and treatment selection can introduce bias.2

Reviewed study record

Vitiligo: afamelanotide plus phototherapy

Design

A randomized multicenter study compared afamelanotide plus narrowband UV-B with phototherapy alone.3

Population

The study enrolled 55 adults with nonsegmental vitiligo and Fitzpatrick skin phototypes III–VI.3

Outcomes reported

The combination group had greater reported repigmentation at day 168. Erythema occurred in both groups; nausea and minor infections were reported in the combination group.3

Limitations

The study does not isolate afamelanotide without phototherapy or establish results in all skin phototypes. PubMed links subsequent correspondence about the study.3

Reviewed study record

Acute stroke: early feasibility study

Design

An open-label Phase 2a study assessed safety and exploratory recovery measures without a control group.4

Population

Six patients with acute ischemic stroke who were ineligible for revascularization therapies were enrolled.4

Outcomes reported

The surviving patients showed neurological improvement. One patient died after a recurrent stroke, which investigators assessed as unrelated to the study drug.4

Limitations

Six uncontrolled observations cannot distinguish drug effects from natural recovery or establish safety. The authors called for randomized studies.4

Reviewed source set

  1. PubMed · 26132941Afamelanotide for Erythropoietic Protoporphyria. ↗PubMed PMID 26132941 · EFetch XML reviewed 2026-09-15 · payload SHA-256 b94a37b2a147aaedfdcff20011049a0589c73cd3790c0e727e5e8a209b2d802f
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa1411481. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 40082741German 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). ↗PubMed PMID 40082741 · EFetch XML reviewed 2026-09-15 · payload SHA-256 caf4351b206f34e04bf7b15cc61df01855b2aa73803e20f217c4a3b7f04ed7dc
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/phpp.13012. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  3. PubMed · 25230094Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. ↗PubMed PMID 25230094 · EFetch XML reviewed 2026-09-15 · payload SHA-256 8fb8fb22056577dddd61a9f7dcdc0f316a95df3119b1d7e59a20cfa17d4c3eaf
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1001/jamadermatol.2014.1875. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  4. PubMed · 37496004A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial. ↗PubMed PMID 37496004 · EFetch XML reviewed 2026-09-15 · payload SHA-256 731b17aa519b1df6a26947c5ca31db8b851762d0fecfa77c45625f3b1c6bf266
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1186/s12883-023-03338-9. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Afamelanotide?

U.S. label record. The cited DailyMed label identifies Afamelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

Evidence present

What records are connected here?

Evidence lanes
3
Source years
12
Drugs@FDA applications
1

These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

Coverage gaps

What remains unknown or unsupported?

PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

Explore the Evidence Map and record counts

Evidence Map v1

What kinds of records connect to Afamelanotide?

Compare collection coverage →

This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

55Selected dated records
56Connected citations
12Populated source years2009–2026
3/4Record lanes present

Registered human studies

Trial composition

2 of 16 selected trial records include at least one phase value; 2 of 16 include a status value in the retained structured contract.

57 public history versions connect to 16 of these trial records across 14 submitted years. Open the record-history collection →

3 exact source-declared trial-publication links connect selected NCT and PMID records. Open the exact graph →

PhasesPhase 1 2Phase 2 1
Status at observationCompleted 2

A phase value is unavailable here for 14 selected records; this is not counted as “no phase.”

A status value is unavailable here for 14 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

5 of 25 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 4Review 2Case Reports 1Letter 1Randomized Controlled Trial 1

Bibliography fields unavailable here for 20 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
1
FDA Federal Register documents
2
DailyMed SPL versions
11
Canonical profile
Published
Profile structured data
Published
Linked dated records
55

Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

Profile publication history and record counts

Exact identifier graph

3 trial-publication links for Afamelanotide

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These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.

Research hub

Explore the Afamelanotide evidence record

Open all 55 records →
55Dated records
3Evidence types
55Cited public sources
12Source years

Change ledger

Recently changed for Afamelanotide

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PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

Record added

Afamelanotide DailyMed SPL version 1

DailyMed lists Structured Product Labeling version 1 for the reviewed Afamelanotide label family with a published date of 2019-12-31. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

PeptideScanner change date
August 22, 2026
Cited source date
December 31, 2019
Evidence lane
Regulatory
Record added

Afamelanotide DailyMed SPL version 10

DailyMed lists Structured Product Labeling version 10 for the reviewed Afamelanotide label family with a published date of 2026-02-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

PeptideScanner change date
August 22, 2026
Cited source date
February 6, 2026
Evidence lane
Regulatory
Record added

Afamelanotide DailyMed SPL version 11

DailyMed lists Structured Product Labeling version 11 for the reviewed Afamelanotide label family with a published date of 2026-05-13. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

PeptideScanner change date
August 22, 2026
Cited source date
May 13, 2026
Evidence lane
Regulatory

Official-source collections

Source records for Afamelanotide

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PubMed25

5 with attributed title, venue, publication-date, and type metadata.

  1. From darkness to light: Case report on afamelanotide-treatment in a 9-year-old child with erythropoietic protoporphyria.JAAD case reports · 2025 11 24
  2. Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.Clinical and experimental dermatology · 2025 Oct 27
  3. Afamelanotide in protoporphyria and other skin diseases: a review.Postepy dermatologii i alergologii · 2024 04 12
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ClinicalTrials.gov16

57 public history versions across these dated registry records; status labels apply only to each cited observation.

  1. NCT06388642Registry update July 27, 2026 · completed at observation
  2. NCT04525157Registry update September 22, 2023 · completed at observation
  3. NCT04962503Registry update April 11, 2023 · completed at observation
Explore all selected trial records →Explore all public record history →
DailyMed SPL history11

Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.

  1. SPL version 11Published 2026-05-13 · ZIP SHA-256 2524c0069e68…
  2. SPL version 10Published 2026-02-06 · ZIP SHA-256 1cac8e7cf890…
  3. SPL version 9Published 2025-11-17 · ZIP SHA-256 d289cd6d2669…
  4. SPL version 8Published 2024-08-16 · ZIP SHA-256 1461dcd0568c…
  5. SPL version 7Published 2023-10-17 · ZIP SHA-256 26a1efa1358d…
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Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

Evidence types

Coverage by source year

Selected records span September 15, 2009 to July 27, 2026.

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Profiles with overlapping source-year coverage

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These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

Leuprolide12 shared source years215 dated records · 4 evidence typesLiraglutide12 shared source years167 dated records · 4 evidence typesOctreotide12 shared source years160 dated records · 4 evidence typesTeriparatide12 shared source years149 dated records · 3 evidence types

These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

Evidence summary

What the cited records say

The cited DailyMed label identifies Afamelanotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.

This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

Cited context

Related records

Organizations named in cited records

  • U.S. National Library of Medicine

Dated source history

Updates connected to this profile

Open the full cross-source timeline →
  1. Clinical trials

    ClinicalTrials.gov record NCT06388642

    PeptideScanner retained ClinicalTrials.gov record NCT06388642 at 2026-08-10T18:10:03.859Z. Its registry update date was 2026-07-27, and PeptideScanner's reviewed identity mapping was afamelanotide.

  2. Literature metadata

    PubMed record PMID 41547183

    PeptideScanner retained PubMed bibliographic metadata for PMID 41547183 at 2026-07-30T16:14:14.777Z. PubMed recorded a metadata revision date of 2026-06-26 and an Entrez history date of 2026-01-17. PeptideScanner associated this retained record with the identity slug afamelanotide. These dates describe PubMed metadata history, not the article's original publication date.

  3. Regulatory

    Afamelanotide DailyMed SPL version 11

    DailyMed lists Structured Product Labeling version 11 for the reviewed Afamelanotide label family with a published date of 2026-05-13. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

  4. Literature metadata

    PubMed record PMID 41793078

    PeptideScanner retained PubMed bibliographic metadata for PMID 41793078 at 2026-07-30T16:23:41.287Z. PubMed recorded a metadata revision date of 2026-03-07 and an Entrez history date of 2026-03-07. PeptideScanner associated this retained record with the identity slug afamelanotide. These dates describe PubMed metadata history, not the article's original publication date.

  5. Literature metadata

    PubMed record PMID 38634774

    PeptideScanner retained PubMed bibliographic metadata for PMID 38634774 at 2026-07-30T16:23:36.263Z. PubMed recorded a metadata revision date of 2026-03-06 and an Entrez history date of 2024-04-18. PeptideScanner associated this retained record with the identity slug afamelanotide. These dates describe PubMed metadata history, not the article's original publication date.

  6. Literature metadata

    PubMed record PMID 38736212

    PeptideScanner retained PubMed bibliographic metadata for PMID 38736212 at 2026-07-30T16:23:36.274Z. PubMed recorded a metadata revision date of 2026-03-06 and an Entrez history date of 2024-05-13. PeptideScanner associated this retained record with the identity slug afamelanotide. These dates describe PubMed metadata history, not the article's original publication date.

  7. Regulatory

    Afamelanotide DailyMed SPL version 10

    DailyMed lists Structured Product Labeling version 10 for the reviewed Afamelanotide label family with a published date of 2026-02-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

  8. Literature metadata

    PubMed record PMID 25494545

    PeptideScanner retained PubMed bibliographic metadata for PMID 25494545 at 2026-07-30T16:30:52.686Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2014-12-16. PeptideScanner associated this retained record with the identity slug afamelanotide. These dates describe PubMed metadata history, not the article's original publication date.

  9. Literature metadata

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

    PubMed lists PMID 41542313 in JAAD case reports as Case Reports, Journal Article, with publication-date metadata of 2025-11-24 (day precision). PeptideScanner associated the retained record with the identity slug afamelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  10. Regulatory

    Afamelanotide DailyMed SPL version 9

    DailyMed lists Structured Product Labeling version 9 for the reviewed Afamelanotide label family with a published date of 2025-11-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.

  11. Literature metadata

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

    PubMed lists PMID 40692281 in Clinical and experimental dermatology as Journal Article, with publication-date metadata of 2025-10-27 (day precision). PeptideScanner associated the retained record with the identity slug afamelanotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

  12. Regulatory

    Afamelanotide DailyMed SPL version 8

    DailyMed lists Structured Product Labeling version 8 for the reviewed Afamelanotide label family with a published date of 2024-08-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.