Afamelanotide | ||||
CAS NO.: | 75921-69-6 | |||
Chemical Formula: | C78H111N21O19 | |||
Molecular Weight: | 1646.8000 | |||
DMF&GMP status: | Please contact us for more details. | Description: |
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.
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Approvals | ||||
Active Ingredient | Dosage Form; Route | Strength | Proprietary Name | Applicant |
AFAMELANOTIDE | IMPLANT;SUBCUTANEOUS | 16MG | SCENESSE | CLINUVEL INC |
Patent Data | ||||
Patent No. | Patent Expiration | Drug Substance Claim | Drug Product Claim | Patent Use Code |
8334265 | 03/11/2029 | U-2638 | ||
10076555 | 02/11/2025 | U-2638 | ||
Exclusive Data | ||||
Exclusivity Code | Exclusivity Expiration | |||
NCE | 10/08/2024 | |||
ODE-270 | 10/08/2026 | |||