Otsuka Initiates Global Phase 3 Trial Of Repinatrabit For Phenylketonuria

rttnews
2025.12.19 02:35
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Otsuka Pharmaceutical Co., Ltd. has launched a global Phase 3 clinical trial for repinatrabit, an oral therapy for phenylketonuria (PKU). The trial aims to assess the efficacy, safety, and tolerability of repinatrabit, which has received orphan drug designation from the FDA. Interim data showed significant reduction in blood Phe levels and confirmed safety and tolerability.