Compounds / Afamelanotide

Afamelanotide

Scenesse · Melanotan-1 · Melanotan I

Afamelanotide has 22 registered human trials — it is genuinely well studied. The question worth asking is what those trials were studying, because it is often not what the compound is sold for.

In short

  • 22 registered human trials exist for Afamelanotide.
  • No registered trial lists tanning or photoprotection as a studied condition.
  • Afamelanotide is FDA-approved — but only for a specific indication, not general use.
  • What has actually been studied: erythropoietic protoporphyria, vitiligo.
  • No study is currently open to new participants.
  • Last checked against ClinicalTrials.gov on 2026-07-27.
22
Registered human trials
1
Under way, incl. closed to enrolment
Yes
FDA approved
Pre
P1
P2
P3
Furthest stage reached

FDA-approved (Scenesse, 2019) to increase pain-free light exposure in adults with erythropoietic protoporphyria. Not approved for tanning.

What it's sold for

  • Tanning
  • Photoprotection
  • Skin pigmentation

What has actually been tested

  • Erythropoietic Protoporphyria
  • Vitiligo
  • Xeroderma Pigmentosum
  • Acne Vulgaris
  • Actinic Keratoses
  • Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
  • Arterial Ischemic Stroke
  • Carcinoma, Squamous Cell

Is it studied for what it's sold for?

Each claim below is matched against the condition and title fields of every registered trial. Not listed means no trial names it as a studied condition — not that it has been disproven, and not that no trial touches it indirectly.

Not listed Tanning
Not listed Photoprotection
Studied Skin pigmentation

Every trial on record

Every registered human study we can find for Afamelanotide. Click any ID to read the original record — we would rather you checked us than trusted us.

Trial IDTitleConditionPhaseStatusEnrolled
NCT00979745 Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) Erythropoietic Protoporphyria Phase 3 Completed 74
NCT04525157 Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) Vitiligo Phase 2 Completed 21
NCT01382589 Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Vitiligo Phase 2 Completed 15
NCT06388642 Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients Erythropoietic Protoporphyria Phase 2 Completed 28
NCT03634137 Implant Pharmacokinetic and Pharmacodynamic Study Healthy Phase 1 Completed 24
NCT01097044 Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Erythropoietic Protoporphyria Phase 2 Completed 77
NCT04053270 Multicentre Phase III Erythropoietic Protoporphyria Study Erythropoietic Protoporphyria Phase 3 Completed 100
NCT01430195 Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) Vitiligo Phase 1 Completed 56
NCT04943159 Afamelanotide in Patients Suffering With Acne Vulgaris Acne Vulgaris Phase 2 Completed 3
NCT04578496 A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) Erythropoietic Protoporphyria Phase 3 Completed 16
NCT04704713 Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) Polymorphic Light Eruption Phase 3 Completed 31
NCT05854784 Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) Variegate Porphyria Phase 2 Completed 6
NCT05368857 DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers Phase 1 Completed 10
NCT04962503 A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Arterial Ischemic Stroke Phase 2 Completed 6
NCT04425746 Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium Patients Undergoing Photodynamic Therapy Using Porfimer Sodium Phase 2 Completed 16
NCT01605136 Phase III Confirmatory Study in Erythropoietic Protoporphyria Erythropoietic Protoporphyria Phase 3 Completed 93
NCT00859534 Phase II Solar Urticaria (SU) Pilot Study Solar Urticaria Phase 2 Completed 5
NCT00829192 Phase II AK Study in Organ Transplant Patients Actinic Keratoses, Carcinoma, Squamous Cell Phase 2 Status not updated 200
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 Vitiligo Phase 3 Running, closed to new participants 200
NCT05159752 A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) Xeroderma Pigmentosum Phase 2 Status not updated 6
NCT05370235 A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V Xeroderma Pigmentosum Phase 2 Status not updated 6
NCT05210582 A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face Vitiligo Phase 2 Status not updated 6
—Read this
A trial count is not a verdict
These numbers describe how much has been formally studied in humans, not whether something works or is safe for you. A compound can be tested for one condition and sold for another — which is usually the story. This page is automated aggregation from public registries; no physician has reviewed it. Take anything here to a clinician.

Why sources disagree on this number

Different sites publish different counts for Afamelanotide because they are answering different questions. Here is every way of counting the same set of studies, so you can see which rule produces which number.

22
Registered human trials the number we publish
Interventional studies in people, listed on ClinicalTrials.gov, at any status.
17
Completed
Registered trials whose status is "completed".
1
Still running
Recruiting, not yet recruiting, or active.
0
Stopped early
Terminated, withdrawn, or suspended.
22
With a stated phase
Registered trials tagged Phase 1-4.
3
100+ participants
Registered trials enrolling at least 100 people.
1
Observational studies
Studies that watch rather than intervene.
You may see a lower number than 22.

Sources that count only completed studies get 17. We count registered trials at any status, because a trial that is recruiting is still a real trial and is the thing most likely to change this page. Neither number is wrong; they answer different questions.

Which number should you use?

For "how much human evidence exists", 22 is the honest answer, with the caveat that 17 have actually finished. Every trial is listed on this page with its ID — if you disagree with how we count, you can recount it yourself in about a minute.

Common questions about Afamelanotide

How many human trials does Afamelanotide have?

22. That is the number of registered interventional human studies we can find, each listed on this page with a link to its original record.

Is Afamelanotide FDA approved?

Yes, but read the detail: FDA-approved (Scenesse, 2019) to increase pain-free light exposure in adults with erythropoietic protoporphyria. Not approved for tanning. An approval for one condition is not an approval for everything it is marketed for.

What is Afamelanotide actually being tested for?

Registered studies cover: erythropoietic protoporphyria, vitiligo, healthy. Compare that to what it is marketed for — the two lists are often different, which is the whole point of this page.

Where does this data come from?

ClinicalTrials.gov, the US public registry of clinical studies. We count interventional human studies only — observational studies are not evidence of effect. Every trial on this page links to its original record so you can check us rather than trust us.

Get told when this changes

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