What is Melanotan I?

A synthetic melanotropin (α-MSH analog), afamelanotide, studied for pigmentation; the approved product is an implant.

Melanotan I in the library · Cosmetic & Skin Peptides · Human Trials · What are peptides?

23 registered trials · 15 indexed papers · 66 human / 14 animal studies

From the PeptideWhiz library entry. "As described" sections summarize claims made in the sources; they are not PeptideWhiz endorsements.

Evidence limits (as described)

  • Melanocortin research involving pigmentation is described as not eliminating ultraviolet risk, and a research vial cannot be assumed equivalent to material used in a controlled trial.
  • Product identity, impurities, sterility, stability, exposure and pharmacokinetics are described as requiring formulation-specific evidence.

Registered human trials (23)

TrialPhaseStatusYearEnrolled
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria PatientsPhase 1/Phase 2completed202428
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 VitiligoPhase 3active not recruiting2023200
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)Phase 2completed20236
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and VPhase 2unknown20226
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the FacePhase 2unknown20226
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy VolunteersPhase 1completed202210
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)Phase 2unknown20216
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)Phase 2completed20216
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)Phase 2completed201421
Phase III Confirmatory Study in Erythropoietic ProtoporphyriaPhase 3completed201293
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Phase 3completed201116
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental VitiligoPhase 2completed201115
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)Phase 1completed201156
Afamelanotide in Patients Suffering With Acne VulgarisPhase 2completed20103
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)Phase 3completed201031
Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)Phase 2completed201077
Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)Phase 3completed200974
Implant Pharmacokinetic and Pharmacodynamic StudyPhase 1completed200924
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer SodiumPhase 2completed200816
Phase II Solar Urticaria (SU) Pilot StudyPhase 2completed20085
Multicentre Phase III Erythropoietic Protoporphyria StudyPhase 3completed2007100
Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)completed200718
Phase II AK Study in Organ Transplant PatientsPhase 2unknown2007200

Peer-reviewed studies (15)

PaperAuthorsJournalYearType
Adjunctive use of Polypodium leucotomos extract in patients with erythropoietic protoporphyria: An exploratory studyShetty N et al.Photochemistry and photobiology2026Clinical Trial
German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide [amount hidden] (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP)Homey B et al.Photodermatology, photoimmunology & photomedicine2025Observational Study
The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort studyKluijver LG et al.The British journal of dermatology2024Observational Study
A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trialStanislaus V et al.BMC neurology2023Clinical Trial, Phase II
Increased phototoxic burn tolerance time and quality of life in patients with erythropoietic protoporphyria treated with afamelanotide - a three years observational studyBarman-Aksözen J et al.Orphanet journal of rare diseases2020Observational Study
Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in AsiansToh JJH et al.Journal of the American Academy of Dermatology2020Randomized Controlled Trial
Afamelanotide for Erythropoietic ProtoporphyriaLangendonk JG et al.The New England journal of medicine2015Randomized Controlled Trial
Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyriaBiolcati G et al.The British journal of dermatology2015Observational Study
Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodiesLengweiler S et al.Skin pharmacology and physiology2015Clinical Trial, Phase III
Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trialLim HW et al.JAMA dermatology2015Randomized Controlled Trial
Efficacy of the melanocortin analogue Nle4-D-Phe7-α-melanocyte-stimulating hormone in the treatment of patients with Hailey-Hailey diseaseBiolcati G et al.Clinical and experimental dermatology2014Clinical Trial, Phase II
Beneficial effects of the melanocortin analogue Nle4-D-Phe7-α-MSH in acne vulgarisBöhm M et al.Journal of the European Academy of Dermatology and Venereology : JEADV2014Clinical Trial, Phase II
Systemic photoprotection in solar urticaria with α-melanocyte-stimulating hormone analogue [Nle4-D-Phe7]-α-MSHHaylett AK et al.The British journal of dermatology2011Clinical Trial, Phase II
Mitigating photosensitivity of erythropoietic protoporphyria patients by an agonistic analog of alpha-melanocyte stimulating hormoneHarms JH et al.Photochemistry and photobiology2009Clinical Trial
Skin pigmentation and pharmacokinetics of melanotan-I in humansUgwu SO et al.Biopharmaceutics & drug disposition1997Randomized Controlled Trial

More cited research

Conditions researched

Related compounds

FAQ

What is Melanotan I?

A synthetic melanotropin (α-MSH analog), afamelanotide, studied for pigmentation; the approved product is an implant.

How many registered human trials study Melanotan I?

The PeptideWhiz trial index lists 23 registered trials for Melanotan I, the most recent from 2024.

How much published research exists on Melanotan I?

The PeptideWhiz paper index links 15 PubMed papers to Melanotan I; by study type, 66 human and 14 animal studies.

Which conditions is Melanotan I researched for?

Acne, Concussion, traumatic brain injury & stroke recovery, Skin, hair loss, wounds & mast-cell/histamine reactivity.

Research and education only. Not medical advice. No dosing guidance. Data: ClinicalTrials.gov registry and PubMed via the PeptideWhiz index (204,289 studies).

Reported dosing ranges from research