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Home/Compounds/Afamelanotide
CosmeticFDA approvedRx required

Afamelanotide

Also known as: Scenesse · Melanotan-I · CUV1647
Brands: Scenesse

Synthetic α-MSH analog approved to increase pain-free light exposure in erythropoietic protoporphyria (EPP).

A
Grade A
Multiple human RCTs
Human studies25
PubMed citations27
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Potent synthetic analog of α-melanocyte-stimulating hormone (α-MSH) that binds melanocortin-1 receptor, inducing eumelanin production.

Evidence summary

25
Human studies
27
PubMed citations
23
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
dizzinessfatiguenauseapruritusurticaria

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for erythropoietic protoporphyria (Scenesse). Not approved for cosmetic tanning.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06388642A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)Completed · Phase 1 · Erythropoietic Protoporphyria · n=28NCT06109649A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of VitiligoActive Not Recruiting · Phase 3 · Vitiligo · n=200NCT05854784Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)-Related Skin Disease.Completed · Phase 2 · Variegate Porphyria · n=6NCT04525157A Two-Arm, Randomized, Double-Blind, Phase IIb Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source With Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental Vitiligo AND A Single-Arm, Open Label, Phase IIb Study to Evaluate the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants Plus Narrow-Band Ultraviolet B (NB-UVB) Light Source in the Treatment of Nonsegmental VitiligoCompleted · Phase 2 · Vitiligo · n=21NCT05370235A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)Unknown · Phase 2 · Xeroderma Pigmentosum · n=6NCT05159752A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)Unknown · Phase 2 · Xeroderma Pigmentosum · n=6NCT04962503A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)Completed · Phase 2 · Arterial Ischemic Stroke · n=6NCT05368857A Mechanistic Study to Evaluate Impact of Subcutaneous Implants of Afamelanotide on Ultraviolet Radiation-induced DNA Damage and DNA Repair Capacity in Healthy Volunteers With Skin Types I-IIICompleted · Phase 1 · Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers · n=10NCT05210582An Open Label, Phase II Study to Assess the Changes in Pigmentation and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants in the Treatment of Vitiligo on the FaceUnknown · Phase 2 · Vitiligo · n=6NCT04943159A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne VulgarisCompleted · Phase 2 · Acne Vulgaris · n=3NCT00979745A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)Completed · Phase 3 · Erythropoietic Protoporphyria · n=74NCT04425746A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer SodiumCompleted · Phase 2 · Patients Undergoing Photodynamic Therapy Using Porfimer Sodium · n=16

Showing 12 of 23 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40817749Nkwanyana N, Kumar A et al. · Silica-Assisted Solid-Phase Peptide Synthesis (SiPPS).Journal of peptide science : an official publication of the European Peptide Society (2025)PMID 40117616Ismail IB, Bhat YJ et al. · Treatment Advances in Vitiligo: An Updated Review.Dermatology practical & conceptual (2025)HumanPMID 38929673Leaf RK, Naik H et al. · Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort.Life (Basel, Switzerland) (2025)PMID 39011756Minder AE, Kluijver LG et al. · Erythropoietic protoporphyrias: Pathogenesis, diagnosis and management.Liver international : official journal of the International Association for the Study of the Liver (2024)HumanPMID 38784937Polańska A, Wegner J et al. · Afamelanotide in protoporphyria and other skin diseases: a review.Postepy dermatologii i alergologii (2024)HumanPMID 38634774Kluijver LG, Nekouei Shahraki M et al. · The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study.The British journal of dermatology (2024)HumanPMID 38417409Ju HJ, Bae JM · Bridging Molecular Mechanism and Clinical Practice in Vitiligo Treatment: An Updated Review.Dermatology (Basel, Switzerland) (2024)HumanPMID 37683058Resnik SR, Targett D et al. · Into the Light: Afamelanotide and the Treatment of Erythropoietic Protoporphyria in the United States.Journal of drugs in dermatology : JDD (2023)HumanPMID 37298700Iwanowski T, Kołkowski K et al. · Etiopathogenesis and Emerging Methods for Treatment of Vitiligo.International journal of molecular sciences (2023)HumanPMID 37365323Sweeney P, Gimenez LE et al. · Targeting the central melanocortin system for the treatment of metabolic disorders.Nature reviews. Endocrinology (2023)HumanPMID 38139134Perez-Bootello J, Cova-Martin R et al. · Vitiligo: Pathogenesis and New and Emerging Treatments.International journal of molecular sciences (2023)HumanPMID 36579412Wensink D, Wagenmakers MAEM et al. · Erythropoietic protoporphyria in the Netherlands: Clinical features, psychosocial impact and the effect of afamelanotide.The Journal of dermatology (2023)HumanPMID 28003770Lane AM, McKay JT et al. · Advances in the management of erythropoietic protoporphyria - role of afamelanotide.The application of clinical genetics (2023)HumanPMID 34433901Zhang H, Chen LN et al. · Structural insights into ligand recognition and activation of the melanocortin-4 receptor.Cell research (2022)HumanPMID 33721252Arisi M, Rossi M et al. · Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology (2021)HumanPMID 31958256Karagaiah P, Valle Y et al. · Emerging drugs for the treatment of vitiligo.Expert opinion on emerging drugs (2021)HumanPMID 30704898Balwani M · Erythropoietic Protoporphyria and X-Linked Protoporphyria: pathophysiology, genetics, clinical manifestations, and management.Molecular genetics and metabolism (2020)HumanPMID 31753192Zubair R, Hamzavi IH · Phototherapy for Vitiligo.Dermatologic clinics (2020)HumanPMID 30328490Stölzel U, Kubisch I et al. · [Porphyrias-what is verified?].Der Internist (2019)HumanPMID 30859308Cong TX, Hao D et al. · From pathogenesis of acne vulgaris to anti-acne agents.Archives of dermatological research (2019)Human

Showing 20 of 27 papers. View all on PubMed →