Treats hyperphenylalaninemia (HPA). Sold as Sephience. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Sepiapterin (sold as Sephience), first approved Jul 28, 2025, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Sephience | Part D | $5.7M | New | 34 |
| Impact Of A Phe-Restricted Diet On Gut Health In Children With PKUPhenylketonuria · Birmingham Women's and Children's NHS Foundation Trust | — | Recruiting | Jul 27, 2026 |
| A Study of Sepiapterin in Participants With Phenylketonuria (PKU)Phenylketonuria · PTC Therapeutics | Phase 3 | Recruiting | Mar 8, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 28, 2025 | SephienceNDA 219666 · New molecular entity | Ptc Therap | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
