Takeda Pharmaceutical Company (TAK, Financial) has announced the initiation of two international phase 3 clinical trials for TAK-861 in China, as per the registration information on China's drug clinical trial registry platform.
The first trial evaluates the efficacy and safety of TAK-861 in treating narcolepsy with cataplexy. The second trial aims to assess the long-term safety and tolerance of TAK-861 in patients with selected central hypersomnia disorders.
TAK-861 is an oral orexin receptor 2 (OX2R) agonist. It has been recognized as a breakthrough therapy for the treatment of type 1 narcolepsy (NT1) by China's National Medical Products Administration (NMPA) and has also received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for addressing excessive daytime sleepiness in NT1.
