Summary
Afamelanotide has reached Phase III as its most advanced recorded development stage across any indication, and the database holds no approval for Vitiligo. ClinicalTrials.gov lists 5 registered trials linking Afamelanotide to Vitiligo: 1 is active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06109649). It plans or enrolled 200 participants. Registration activity spans 2011 to 2023. The literature layer holds 3 publications for this pair: 1 systematic review and 2 randomised controlled trial publications. Publication years run from 2015 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Vitiligo ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous complete repigmentation extremely rare (<1%); partial spontaneous repigmentation possible in small lesions; progressive without treatment in most patients.
Evidence table
| Evidence tier | B · Moderate |
|---|---|
| Evidence score | 36.0 (trials 17.0, literature 9.0, tier 10, approved bonus 0.0) |
| Registered trials | 5 total: 0 recruiting, 1 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 3 (2 randomised controlled trial publications, 1 systematic review) |
| Agent type | Biologic |
| Development stage (any indication) | Phase III |
| Mechanism / class | Not recorded |
| Data sources | Open Targets |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06109649 | A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo 2023 | active, not recruiting | Phase 3 | 200 |
| NCT01382589 | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo 2011 | completed | Phase 2 | 15 |
| NCT04525157 | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) 2014 | completed | Phase 2 | 21 |
| NCT05210582 | A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face 2022 | status unknown | Phase 2 | 6 |
| NCT01430195 | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) 2011 | completed | Phase 1 | 56 |
Published literature
- Systematic review A systematic review of case series and clinical trials investigating systemic oral or injectable therapies for the treatment of vitiligoJafarzadeh A, Pour Mohammad A, Khosravi M et al. · Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2024 · PMID 38454597
- Randomized controlled trial Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in AsiansToh JJH, Chuah SY, Jhingan A et al. · Journal of the American Academy of Dermatology · 2020 · PMID 31987791
- Randomized controlled trial Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trialLim HW, Grimes PE, Agbai O et al. · JAMA dermatology · 2015 · PMID 25230094
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is B (Moderate), derived from the strength of the disease association recorded in Open Targets. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Afamelanotide approved for Vitiligo?
Afamelanotide has reached Phase III as its most advanced recorded development stage across any indication, and the database holds no approval for Vitiligo. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Afamelanotide in clinical trials for Vitiligo?
ClinicalTrials.gov lists 5 registered trials linking Afamelanotide to Vitiligo: 1 is active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06109649). It plans or enrolled 200 participants. Registration activity spans 2011 to 2023.
What does the evidence show for Afamelanotide in Vitiligo?
Afamelanotide has both completed registered trials and synthesis-level publications linked to Vitiligo. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is B (Moderate), derived from the strength of the disease association recorded in Open Targets. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.