Takeda gains Japan approval for ORZEYFUL narcolepsy drug

• Takeda received approval from Japan’s Ministry of Health, Labour and Welfare for ORZEYFUL (oveporexton) to treat narcolepsy type 1 in adults.
• The approval marks the third global approval for ORZEYFUL after approvals in China and the United States.
• Takeda stated that it is preparing for launch and plans to make ORZEYFUL available in Japan as quickly as possible.

Takeda (NYSE:TAK) announced that Japan’s Ministry of Health, Labour and Welfare approved ORZEYFUL (oveporexton) for adults with narcolepsy type 1, making it the company’s third global approval for the treatment.

The approval follows results from Takeda’s Phase 3 FirstLight and RadiantLight studies, which showed statistically significant improvements across multiple narcolepsy type 1 symptoms, including excessive daytime sleepiness and cataplexy.

ORZEYFUL is an oral orexin receptor 2 agonist designed to target orexin deficiency linked to narcolepsy type 1, and Takeda stated it is preparing for launch following the Japanese approval.

Takeda stated that ORZEYFUL could provide a broader treatment approach for narcolepsy type 1.

Takeda developed ORZEYFUL through research conducted in Japan and stated that the medicine represents part of its broader orexin research strategy focused on neurological conditions.

Narcolepsy type 1 is a chronic neurological disorder caused by orexin deficiency and can involve excessive daytime sleepiness, cataplexy, disrupted nighttime sleep, sleep paralysis, hallucinations, and cognitive symptoms.