Wednesday, July 8, 2026

Drug profile · INN

afamelanotide

afamelanotide (SCENESSE) is a melanocortin receptor 1 agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved Dermatologicals (D02) D02BB02
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — afamelanotide
US status
approved
Class
Dermatologicals (D02)
Route
SUBCUTANEOUS
Patents
0
Programs
4
Data quality
0.84

Quick answer

afamelanotide (SCENESSE) is a melanocortin receptor 1 agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN afamelanotide
Brand SCENESSE
Mechanism Melanocortin receptor 1 agonist
Target Melanocyte-stimulating hormone receptor
Therapeutic class Dermatologicals (D02)
Route SUBCUTANEOUS
Formulation IMPLANT
ATC code D02BB02

Mechanism of action

Melanocortin receptor 1 agonist

Primary target: Melanocyte-stimulating hormone receptor

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. SCENESSE 16 mg implant Phase 3 · CLINUVEL PHARMACEUTICALS · Vitiligo
  2. Not the same excipients as Test, Balinatunfib Phase 2 · Sanofi-Aventis U.S · Colitis Ulcerative
  3. SCENESSE 16 mg implant Phase 2 · CLINUVEL PHARMACEUTICALS · Erythropoietic Protoporphyria (EPP)
  4. Not applicable Phase 1 · Chiesi Farmaceutici S.p.A · Non-cystic fibrosis bronchiectasis

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. dupilumab Dermatologicals (D11)
  3. imiquimod Dermatologicals (D06)
  4. lebrikizumab Dermatologicals (D11)
  5. retapamulin Dermatologicals (D06)
  6. tacrolimus Dermatologicals (D11)

Frequently asked questions

What is afamelanotide?

afamelanotide (SCENESSE) is a melanocortin receptor 1 agonist. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for afamelanotide?

SCENESSE is a marketed brand name for afamelanotide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of afamelanotide?

afamelanotide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.