Sephience
Sephience ingredients
| Active ingredient | Strength |
|---|---|
| Sepiapterin | 250 mg/1, 1000 mg/1 |
What Sephience is used for
The FDA lists the approved uses on the official label (below). In the EU, sepiapterin is approved as Sephience for:
Treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Sephience
- Generic name
- Sepiapterin
- Made by
- PTC Therapeutics Inc.
- Forms
- Powder
- Given
- Oral
- FDA approval
- New drug application (NDA) NDA219666
- On the US market since
- 2025
Official information
- Sephience prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Sepiapterin)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Sephience?
Sephience (Sepiapterin) is a specialist medicine made by PTC Therapeutics Inc., approved by the US FDA.
What are the ingredients of Sephience?
Sephience contains Sepiapterin (250 mg/1, 1000 mg/1).
Is Sephience approved in Europe?
The same active substance is approved in the EU as Sephience.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA