Relief Therapeutics Reports Positive Outcomes in RLF-OD032 Study

Relief Therapeutics Holding SA announced promising results from a pivotal bioequivalence study of RLF-OD032, a concentrated liquid formulation of sapropterin dihydrochloride for phenylketonuria (PKU) treatment. The study confirmed RLF-OD032's bioequivalence to KUVAN® Powder, meeting primary pharmacokinetic endpoints as defined by the FDA.

This randomized, open-label, two-way crossover study demonstrated the innovative formulation's potential as a patient-friendly alternative, especially for those struggling with existing high-volume therapies. RLF-OD032's low-volume, ready-to-use formulation aims to enhance treatment adherence and quality of life for PKU patients.

With plans to submit a 505(b)(2) New Drug Application in early 2026, Relief Therapeutics is poised to advance RLF-OD032 through regulatory pathways, seeking U.S. marketing approval.