Skin & beauty

Afamelanotide

Peptilex evidence grade ABCDEUpdated 19 Oct 2026 How grades work

Type: Synthetic analogue of alpha-MSH (melanocortin receptor agonist)
Main use or focus: Prevention of light-induced pain in erythropoietic protoporphyria (EPP)
Also known as: Scenesse, melanotan I

Key studies from the book

94 adults with EPP, 6 months; median pain-free time in direct sunlight 69.4 hours versus 40.8 hours on placebo.
Langendonk JG et al., US trial – New England Journal of Medicine, 2015
74 adults with EPP, 9 months; median pain-free time 6.0 versus 0.8 hours and fewer painful light reactions (77 versus 146).
Langendonk JG et al., EU trial – same publication

All key studies, risks and open questions are in the book.

Research at a glance

Publications by typePubMed, all years

All papers104

Human studies73

Animal studies only1

Randomized trials3

Meta-analyses & systematic reviews2

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Registered trials by phaseClinicalTrials.gov · name in study title

ongoing / startingcompleted / other

Phase 12

Phase 210

Phase 32

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Trial starts per yearClinicalTrials.gov · by start date (planned starts included)

2016

2018

2020

32022

12024

2026

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Go deeper

Full profile in the book

What it is, how it acts, the key studies, risks and open questions.

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An evidence grade (A–E) and the key studies for every peptide
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Registered trials

ClinicalTrials.gov · name in study title · ongoing first

Study	Phase	Status	Participants	Start
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 NCT06109649Clinuvel, Inc.	Phase 3	Running	200	Oct 2023
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) NCT04704713Clinuvel Pharmaceuticals Limited	Phase 3	Completed	31	May 2010
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients NCT06388642Clinuvel Europe Limited	Phase 1/2	Completed	28	Mar 2024
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) NCT04525157Clinuvel Pharmaceuticals Limited	Phase 2	Completed	21	Jun 2014
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium NCT04425746Clinuvel Pharmaceuticals Limited	Phase 2	Completed	16	Aug 2008
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo NCT01382589Clinuvel Pharmaceuticals Limited	Phase 2	Completed	15	Sep 2011
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) NCT04962503Clinuvel Pharmaceuticals Limited	Phase 2	Completed	6	Jun 2021
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) NCT05854784Clinuvel Pharmaceuticals Limited	Phase 2	Completed	6	Mar 2023
Afamelanotide in Patients Suffering With Acne Vulgaris NCT04943159Clinuvel Pharmaceuticals Limited	Phase 2	Completed	3	Aug 2010
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) NCT01430195Clinuvel Pharmaceuticals Limited	Phase 1	Completed	56	Jun 2011

Show 4 moreShow fewer

Study	Phase	Status	Participants	Start
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers NCT05368857Clinuvel (UK) Ltd.	Phase 1	Completed	10	Jan 2022
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) NCT05159752Clinuvel Europe Limited	Phase 2	Status unknown	6	Oct 2021
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face NCT05210582Clinuvel, Inc.	Phase 2	Status unknown	6	Oct 2022
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V NCT05370235Clinuvel Europe Limited	Phase 2	Status unknown	6	Mar 2022

Latest key papers

PubMed · newest first

2024
A systematic review of case series and clinical trials investigating systemic oral or injectable therapies for the treatment of vitiligo
Systematic reviewJafarzadeh A et al. · Skin Research and TechnologyPMID 38454597
2023
Experimental and approved treatments for skin photosensitivity in individuals with erythropoietic protoporphyria or X-linked protoporphyria: A systematic review
Systematic reviewHeerfordt IM et al. · Biomedicine & Pharmacotherapy = Biomedecine & PharmacotherapiePMID 36525819
2020
Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians
Human RCTToh JJH et al. · Journal of the American Academy of DermatologyPMID 31987791
2015
Afamelanotide for Erythropoietic Protoporphyria
Human RCTLangendonk JG et al. · NEJMPMID 26132941
2015
Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial
Human RCTLim HW et al. · JAMA DermatologyPMID 25230094

Related peptides

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