Drug Profile

Sapropterin dihydrochloride oral suspension - APR Applied Pharma Research

Alternative Names: APR-OD032; RLF-OD032

Latest Information Update: 06 Nov 2025

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At a glance

Originator Meta Healthcare
Developer RELIEF THERAPEUTICS Holding
Class
Mechanism of Action Undefined mechanism

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Phase I Phenylketonuria

Most Recent Events

29 Oct 2025 Relief Therapeutics announces intention to submit NDA to US FDA for Phenylketonuria in early 2026
29 Oct 2025 Adverse events and pharmacokinetics data from a phase-I trial in Phenylketonuria released by Relief Therapeutics
23 May 2025 APR Applied Pharma Research plans a phase I bioequivalence trial in Healthy volunteers (PO, Suspension), in June 2025 (NCT06987773)

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