Takeda launches narcolepsy drug Orzeyful in Japan and China

Takeda Pharmaceutical (NYSE: TAK) announced the simultaneous launch of Orzeyful (oveporexton) in Japan and China for the treatment of narcolepsy type 1 (NT1), making the drug available to clinicians in both markets.

Orzeyful is an oral orexin receptor 2 (OX2R) agonist designed to address the underlying orexin deficiency associated with NT1. The drug received approval from China's National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare within a month of each other, and was also approved by the U.S. Food and Drug Administration. In China, the drug is approved for adolescents aged 16 and older and adults, while approvals in Japan and the U.S. cover adults with NT1.

A U.S. launch is expected next month, pending completion of Drug Enforcement Administration scheduling.

NT1 is a chronic neurological disease characterized by symptoms including excessive daytime sleepiness, cataplexy, disrupted nighttime sleep, sleep paralysis, hallucinations, and cognitive symptoms. According to the press release, people with narcolepsy have approximately twice the rate of healthcare resource utilization compared with those without the condition.

Phase 3 clinical trials showed statistically significant improvements with Orzeyful compared to placebo across measures of wakefulness, sleepiness, cataplexy, disease severity, and quality of life, with p-values below 0.001 across doses over 12 weeks. The most commonly reported side effects include insomnia, urinary urgency, urinary frequency, and excessive saliva.

Takeda stated that additional regulatory submissions are underway in other markets. The company also has other orexin agonists in development, including TAK-360 for NT1, narcolepsy type 2, and idiopathic hypersomnia, as well as TAK-495.

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