Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms.

“The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.”

NT1 is a rare, chronic neurological disease driven by a loss of orexin and affects an estimated 120,000 people in the U.S. People with NT1 experience excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms and disrupted nighttime sleep that can severely impact multiple aspects of daily life, including work, education and social interactions.

"For those of us living with narcolepsy type 1, symptoms reshape everyday life and extend far beyond what most people understand about the condition," said Julie Flygare, President and CEO at Project Sleep and a person with NT1. "ORZEYFUL’s approval is a historic moment that expands our treatment choices and gives me great hope for the future and for our community."

“Until now, people have managed narcolepsy type 1 with treatments that target symptom relief,” said Dr. Emmanuel Mignot, M.D., Ph.D., principal U.S. investigator in the ORZEYFUL Phase 3 program. “As the first and only approved orexin therapy to treat the broad spectrum of the disease, ORZEYFUL can enable a different kind of conversation in the doctor’s office about treatment options.”

The approval is based on a comprehensive clinical program including the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies that showed oveporexton offers statistically significant improvements across the full range of symptoms of the disease. These included improvements in excessive daytime sleepiness, cataplexy and health-related quality of life. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common side effects include trouble sleeping (insomnia), urinary urgency, urinary frequency and excessive saliva. Learn more about the Phase 3 data results here.

"With this approval, we are turning scientific discovery into reality for adults living with narcolepsy type 1," said Andy Plump, M.D., Ph.D., President, Research & Development, Takeda. "ORZEYFUL is just the beginning. With orexin emerging as a powerful therapeutic pathway, Takeda is unlocking the potential of this new class of medicine for patients across a range of disorders.”

Next Steps for ORZEYFUL Availability

The controlled substance classification for ORZEYFUL is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days. After the controlled substance classification is determined, ORZEYFUL will be made available through a specialty pharmacy to U.S. healthcare providers and adults living with NT1. To sign up for updates visit ORZEYFUL.com.

The FDA approval is not expected to have a significant impact on the full year consolidated financial forecast for the fiscal year ending March 31, 2027.

*For information regarding the submission of the new drug application for oveporexton to the U.S. FDA, please refer to Takeda’s press release dated February 10, 2026, “U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1”.