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Drug

Afamelanotide

Established medicine
ClassMelanocortin receptor 1 agonistResearchOngoing clinical research

Also known as Scenesse.

RxNorm2262250ChEMBLCHEMBL441738ATCD02BB02UNIIQW68W3J66U
MC1R
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)-Related Skin Disease.

Clinical trial2025-04-27Results posted · ClinicalTrials.gov

A 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)

Clinical trial2024-06-01Primary completion · ClinicalTrials.gov

A 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)

Clinical trial2024-03-01Primary completion · ClinicalTrials.gov

A 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 Vitiligo

Clinical trial2023-09-22Results posted · ClinicalTrials.gov

A 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)

Clinical trial2023-04-11Results posted · ClinicalTrials.gov

An 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 Face

Clinical trial2023-04-01Primary completion · ClinicalTrials.gov

A 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-III

Clinical trial2023-02-01Completed · ClinicalTrials.gov

A 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 Vulgaris

Clinical trial2021-10-26Results posted · ClinicalTrials.gov

A 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)

Clinical trial2021-10-12Results posted · ClinicalTrials.gov

A 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 Sodium

Clinical trial2021-10-01Results posted · ClinicalTrials.gov

A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)

Clinical trial2021-03-19Results posted · ClinicalTrials.gov

Approval: Scenesse (EMA)

Regulatory2014-12-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Afamelanotide
Aliases & brands
Scenesse
RxNorm CUI
2262250
ChEMBL ID
CHEMBL441738
ATC codes
D02BB02
UNII
QW68W3J66U
Primary mechanism
Melanocortin receptor 1 agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Melanocyte-stimulating hormone receptor
MC1R · Q01726
AGONISTMelanocortin receptor 1 agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-12-22
Latest approval
2014-12-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2014-12-22Approval
Approval: Scenesse (EMA)

Indication: Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

19 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
19
registered trials across all phases
LATEST COMPLETION 2023
5
Late-stage (III+)
15
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 19
Phase 12Phase 212Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=162014

A Phase III, Multicentre, Double-Blind, Randomized, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=932013

A 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)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=742011

A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=312010

A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=1002009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)-Related Skin Disease.

CompletedPH IIClinuvel Pharmaceuticals Limitedn=62023

A 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-III

CompletedPH IClinuvel (UK) Ltd.n=102023

A 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)

CompletedPH IIClinuvel Pharmaceuticals Limitedn=62022

A 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 Vitiligo

CompletedPH IIClinuvel Pharmaceuticals Limitedn=212016

A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=162014

A Phase III, Multicentre, Double-Blind, Randomized, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

CompletedPH IIIClinuvel Pharmaceuticals Limitedn=932013
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.