Takeda launches oveporexton for adult narcolepsy type 1 in the US
- ORZEYFUL (oveporexton) is indicated for adults with narcolepsy type 1, including cataplexy.
- The oral medicine selectively activates orexin receptor 2 to address orexin deficiency.
- The FDA approved the medicine in August 2026; it was subsequently classified as a Schedule IV controlled substance.
- Accredo Specialty Pharmacy, part of Evernorth Health Services, will dispense the medicine across the US.
US availability and indication
Takeda says ORZEYFUL (oveporexton) is now available by prescription in the United States for adults with narcolepsy type 1 (NT1), including cataplexy. The FDA approved it in August 2026, pending controlled-substance classification; it has since been classified as Schedule IV. Accredo Specialty Pharmacy, part of Evernorth Health Services, will dispense the medicine nationwide.
Mechanism and safety
Oveporexton is an oral orexin receptor 2 (OX2R) agonist intended to restore orexin signaling. The most common adverse reactions reported in Phase 3 studies were insomnia, urinary frequency, urinary urgency and excessive saliva. The prescribing information also warns of possible creatine phosphokinase elevations. ORZEYFUL is contraindicated with strong CYP3A inhibitors, and the company advises monitoring for urinary symptoms and signs of muscle injury.
Disease context
NT1 is a chronic neurological disease associated with loss of orexin. The article estimates that it affects about 120,000 people in the United States and notes that diagnosis can take an average of 10 years.
Source: Takeda