Sepiapterin

Phase 3

PTC Therapeutics, Inc. (PTCT)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

1 competitor in Phenylketonuria

BMRNBMN 331

Phase 1/2

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Drug Information

Target Indication

Phenylketonuria

Clinical Trial

NCT06302348

Last updated: 1/2/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA6/19/2025

Sephience

Treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).

Orphan

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

PTCT

PTC Therapeutics, Inc.

Pharmaceutical Preparations•North America•NASDAQ

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