# FDA Approves Takeda's Orzeyful (oveporexton), First Drug to Treat Full Range of Narcolepsy Type 1 Symptoms

> fda · REPORTED · 2026-08-05

The FDA approved Orzeyful (oveporexton) tablets on August 5, 2026, as the first orexin receptor 2 agonist and the first medicine approved to treat narcolepsy type 1 as a complete disorder, addressing excessive daytime sleepiness, cataplexy, and other core symptoms. The approval was supported by two Phase 3 randomized, double-blind, placebo-controlled trials involving 273 adults.

About Takeda Pharmaceutical: Takeda Pharmaceutical is a global biopharmaceutical company; Orzeyful is its first orexin-restoring therapy targeting the root cause of narcolepsy type 1, a rare neurological sleep disorder affecting approximately 1 in 2,000 people.

- Company: Takeda Pharmaceutical
- Sector: therapeutics
- Primary source: https://aasm.org/fda-approves-orzeyful-for-narcolepsy-type-1-in-adults/

---
Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.