NDAORALPOWDER
Approved
Jul 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
SEPHIENCE (sepiapterin) by PTC Therapeutics. Approved for phenylketonuria. First approved in 2025.
Drug data last refreshed 19h ago
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (1)
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
Started Mar 2024
56 enrolled
Phenylketonuria
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.