Afamelanotide acetate is under clinical development by Clinuvel Pharmaceuticals and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Afamelanotide acetate’s likelihood of approval (LoA) and phase transition for Acute Ischemic Stroke took place on 29 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Afamelanotide acetate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Afamelanotide acetate overview

Afamelanotide (Scenesse) is an analog of the peptide hormone alpha-melanocyte stimulating hormone (alpha-MSH) that tends to induce skin tanning. It is formulated as Implant administered through subcutaneous route. Scenesse is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Afamelanotide acetate is under development for the treatment of  moderate acne vulgaris, vitiligo, acute arterial ischaemic stroke (AIS), erythropoietic protoporphyria, variegate porphyria related skin disease and xeroderma pigmentosum (genetic disorder). It was also under development for chronic urticaria, actinic (solar) keratosis, squamous cell carcinoma, Hailey-Hailey disease (benign familial pemphigus), polymorphous light eruption and unspecified dermatological disorders.

Clinuvel Pharmaceuticals overview

Clinuvel Pharmaceuticals is a biopharmaceutical company which focuses on the development of drugs for the treatment of light related severe skin disorders. The company’s lead product candidate, Scenesse (afamelanotide) is a first-in-class drug targeting erythropoietic protoporphyria (EPP) and is approved in Europe, Australia and the US for treating adult EPP patients. Its other products under development includes CUV9900 and VLRX001 among others. Clinuvel Pharmaceuticals also focused on developing a pediatric formulation of Scenesse for EPP and OTC products for general photoprotective application. The company through its subsidiaries has operations in Australia, Switzerland, Ireland, the UK, the US, and Singapore. Clinuvel Pharmaceuticals is headquartered in Melbourne, Victoria, Australia.

Quick View Afamelanotide acetate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Afamelanotide acetate
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Genetic Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.