Afamelanotide
- Generic Name
- Afamelanotide
- Brand Names
- Scenesse
- Drug Type
- Small Molecule
- Chemical Formula
- C78H111N21O19
- CAS Number
- 75921-69-6
- Unique Ingredient Identifier
- QW68W3J66U
- Background
Afamelanotide is a first-in-class, synthetic, 13-amino acid peptide analogue of the endogenous alpha melanocyte-stimulating hormone (α-MSH). It differs structurally from its endogenous counterpart by only two amino acids - these structural differences improve biological efficacy by imparting a greater affinity for its target and a longer biological half-life. Afamelanotide is currently the only approved drug therapy used in the management of erythropoietic protoporphyria, having received approval in the EU in December 2014 and subsequent FDA approval in October 2019. Despite its relatively recent approval, afamelanotide has been available for use as an orphan drug in both the US and EU since 2008.
- Indication
Afamelanotide is indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
- Associated Conditions
- Phototoxicity reaction
Pharmacokinetics of Afamelanotide in EPP Patients
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- First Posted Date
- 2024-04-29
- Last Posted Date
- 2025-02-12
- Lead Sponsor
- Clinuvel Europe Limited
- Target Recruit Count
- 28
- Registration Number
- NCT06388642
- Locations
- 🇳🇱
CLINUVEL Site, Rotterdam, Netherlands
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
- Conditions
- Vitiligo
- Interventions
- Procedure: NB-UVB Light
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2025-03-04
- Lead Sponsor
- Clinuvel, Inc.
- Target Recruit Count
- 200
- Registration Number
- NCT06109649
- Locations
- 🇬🇧
CLINUVEL site, Manchester, United Kingdom
🇺🇸CLINUVEL Site, Cedar Park, Texas, United States
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
- First Posted Date
- 2023-05-11
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Clinuvel Pharmaceuticals Limited
- Target Recruit Count
- 6
- Registration Number
- NCT05854784
- Locations
- 🇳🇱
CLINUVEL investigational site, Rotterdam, Netherlands
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
- First Posted Date
- 2022-05-11
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- Clinuvel Europe Limited
- Target Recruit Count
- 6
- Registration Number
- NCT05370235
- Locations
- 🇪🇸
CLINUVEL Investigational site, Clinuvel Investigational Site, Spain
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
- Conditions
- Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
- Interventions
- First Posted Date
- 2022-05-10
- Last Posted Date
- 2023-02-09
- Lead Sponsor
- Clinuvel (UK) Ltd.
- Target Recruit Count
- 10
- Registration Number
- NCT05368857
- Locations
- 🇬🇧
CLINUVEL Investigational Site, Clinuvel Investigational Site, United Kingdom
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
- First Posted Date
- 2022-01-27
- Last Posted Date
- 2023-02-09
- Lead Sponsor
- Clinuvel, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT05210582
- Locations
- 🇺🇸
CLINUVEL Investigational site, Detroit, Michigan, United States
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)
- First Posted Date
- 2021-12-16
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- Clinuvel Europe Limited
- Target Recruit Count
- 6
- Registration Number
- NCT05159752
- Locations
- 🇩🇪
CLINUVEL investigative site, Regensburg, Germany
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
- First Posted Date
- 2021-07-15
- Last Posted Date
- 2023-04-11
- Lead Sponsor
- Clinuvel Pharmaceuticals Limited
- Target Recruit Count
- 6
- Registration Number
- NCT04962503
- Locations
- 🇦🇺
The Alfred, Melbourne, Australia
Afamelanotide in Patients Suffering With Acne Vulgaris
- First Posted Date
- 2021-06-29
- Last Posted Date
- 2021-10-26
- Lead Sponsor
- Clinuvel Pharmaceuticals Limited
- Target Recruit Count
- 3
- Registration Number
- NCT04943159
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
- First Posted Date
- 2021-01-12
- Last Posted Date
- 2021-03-19
- Lead Sponsor
- Clinuvel Pharmaceuticals Limited
- Target Recruit Count
- 31
- Registration Number
- NCT04704713
Drug Development Updates
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