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Sepiapterin FDA Approval Status

Last updated by Judith Stewart, BPharm on Oct 30, 2024.

FDA Approved: No
Generic name: sepiapterin
Company: PTC Therapeutics, Inc.
Treatment for: Phenylketonuria

Sepiapterin is a precursor of tetrahydrobiopterin (BH4) in development to reduce blood phenylalanine levels in pediatric and adult patients living with phenylketonuria.

Development timeline for sepiapterin

DateArticle
Oct  1, 2024PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
May 17, 2023PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients

Further information

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