ORZEYFUL (Oveporexton (TAK-861-2001))

August 5, 2026: Takeda (TAK) said the FDA approved ORZEYFUL (oveporexton), an oral orexin receptor 2 agonist, for treatment of narcolepsy type 1 with cataplexy in adults. Takeda describes it as the first approved orexin therapy in the U.S. for NT1.

The approval was based on the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies, which showed statistically significant improvements across NT1 symptoms versus placebo, including excessive daytime sleepiness, cataplexy, and health-related quality of life. The drug was generally well tolerated, with the most common adverse reactions including insomnia, urinary frequency/urgency, and excessive salivation. In pooled Phase 3 data, insomnia occurred in 60% and 55% of the 2 mg BID and 1 mg BID groups versus 1% with placebo; urinary frequency in 58% and 53% versus 5%; urinary urgency in 16% and 15% versus 1%. Asymptomatic CPK elevations >5x ULN were seen in 11% of treated patients versus 5% on placebo.

Takeda said U.S. launch preparations are underway, with DEA controlled-substance scheduling expected within 90 days before commercial availability through a specialty pharmacy. The company also referenced FDA acceptance and Priority Review of the NDA on February 10, 2026.