# Afamelanotide

Afamelanotide has 22 registered human trials. It is marketed for 3 different uses.

**In short**

- 22 registered human trials exist for Afamelanotide.
- Afamelanotide is FDA-approved — FDA-approved (Scenesse, 2019) to increase pain-free light exposure in adults with erythropoietic protoporphyria. Not approved for tanning..
- What has actually been studied: erythropoietic protoporphyria, vitiligo, actinic keratoses.
- Last checked against ClinicalTrials.gov on 2026-07-27.

## What it is sold for

- Tanning
- Photoprotection
- Skin pigmentation

## What has actually been tested

- Erythropoietic Protoporphyria
- Vitiligo
- Actinic Keratoses
- Carcinoma, Squamous Cell
- Organ Transplant Recipients
- Healthy
- Acne Vulgaris
- Polymorphic Light Eruption
- Variegate Porphyria
- Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
- Arterial Ischemic Stroke
- Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
- Xeroderma Pigmentosum
- Solar Urticaria

## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT00979745](https://clinicaltrials.gov/study/NCT00979745) | Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Phase 3 | COMPLETED | 74 |
| [NCT04525157](https://clinicaltrials.gov/study/NCT04525157) | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) | Vitiligo | Phase 2 | COMPLETED | 21 |
| [NCT01382589](https://clinicaltrials.gov/study/NCT01382589) | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo | Vitiligo | Phase 2 | COMPLETED | 15 |
| [NCT06388642](https://clinicaltrials.gov/study/NCT06388642) | Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients | Erythropoietic Protoporphyria | Phase 2 | COMPLETED | 28 |
| [NCT00829192](https://clinicaltrials.gov/study/NCT00829192) | Phase II AK Study in Organ Transplant Patients | Actinic Keratoses, Carcinoma, Squamous Cell | Phase 2 | UNKNOWN | 200 |
| [NCT03634137](https://clinicaltrials.gov/study/NCT03634137) | Implant Pharmacokinetic and Pharmacodynamic Study | Healthy | Phase 1 | COMPLETED | 24 |
| [NCT01097044](https://clinicaltrials.gov/study/NCT01097044) | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Phase 2 | COMPLETED | 77 |
| [NCT04053270](https://clinicaltrials.gov/study/NCT04053270) | Multicentre Phase III Erythropoietic Protoporphyria Study | Erythropoietic Protoporphyria | Phase 3 | COMPLETED | 100 |
| [NCT01430195](https://clinicaltrials.gov/study/NCT01430195) | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) | Vitiligo | Phase 1 | COMPLETED | 56 |
| [NCT04943159](https://clinicaltrials.gov/study/NCT04943159) | Afamelanotide in Patients Suffering With Acne Vulgaris | Acne Vulgaris | Phase 2 | COMPLETED | 3 |
| [NCT04578496](https://clinicaltrials.gov/study/NCT04578496) | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Phase 3 | COMPLETED | 16 |
| [NCT04704713](https://clinicaltrials.gov/study/NCT04704713) | Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) | Polymorphic Light Eruption | Phase 3 | COMPLETED | 31 |
| [NCT05854784](https://clinicaltrials.gov/study/NCT05854784) | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) | Variegate Porphyria | Phase 2 | COMPLETED | 6 |
| [NCT05368857](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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 |
| [NCT06109649](https://clinicaltrials.gov/study/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 | ACTIVE_NOT_RECRUITING | 200 |
| [NCT04425746](https://clinicaltrials.gov/study/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 |
| [NCT05159752](https://clinicaltrials.gov/study/NCT05159752) | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) | Xeroderma Pigmentosum | Phase 2 | UNKNOWN | 6 |
| [NCT01605136](https://clinicaltrials.gov/study/NCT01605136) | Phase III Confirmatory Study in Erythropoietic Protoporphyria | Erythropoietic Protoporphyria | Phase 3 | COMPLETED | 93 |
| [NCT05370235](https://clinicaltrials.gov/study/NCT05370235) | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V | Xeroderma Pigmentosum | Phase 2 | UNKNOWN | 6 |
| [NCT00859534](https://clinicaltrials.gov/study/NCT00859534) | Phase II Solar Urticaria (SU) Pilot Study | Solar Urticaria | Phase 2 | COMPLETED | 5 |
| [NCT05210582](https://clinicaltrials.gov/study/NCT05210582) | A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face | Vitiligo | Phase 2 | UNKNOWN | 6 |

## Common questions

**How many human trials does Afamelanotide have?**
22, each listed above with a link to its original record.

**Is Afamelanotide FDA approved?**
Yes — FDA-approved (Scenesse, 2019) to increase pain-free light exposure in adults with erythropoietic protoporphyria. Not approved for tanning.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/afamelanotide*