accessnewswire.com · Oct 29, 2025
Relief Therapeutics Announces Positive Results from Pivotal Bioequivalence Study of RLF-OD032
RLF-OD032 demonstrated bioequivalence to KUVAN® Powder Study results support planned 505(b)(2) NDA submission in early 2026 GENEVA, SWITZERLAND / ACCESS Newswire / October 29, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced positive results from its pivotal bioequivalence clinical study evaluating RLF-OD032, Relief's innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU). The pivotal study achieved its primary pharmacokinetic endpoints, demonstrating that RLF-OD032 is bioequivalent to KUVAN ® Powder, the reference listed drug, as defined by the U.S. Food and Drug Administration.
