Takeda’s ORZEYFUL Approved in China for Narcolepsy Type 1
Takeda’s ORZEYFUL (oveporexton) Approved in China as First Orexin Agonist and Only Medicine to Treat Narcolepsy Type 1
Oveporexton Introduces a New Class of Medicine for Narcolepsy Type 1 (NT1)
Approval Supported by Robust NT1 Clinical Data Demonstrating Improvements Across the Broad Disease Spectrum
Shanghai, China — July 22, 2026 — Takeda China today announced that the National Medical Products Administration (NMPA) of China has approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adolescents aged 16 years and older and adults. Oveporexton is the first oral orexin receptor 2 (OX2R)-selective agonist approved in China and is the only approved medicine to treat NT1. In addition to securing approval in China, the new drug application is currently under priority review in the United States, where it received Breakthrough Therapy designation, and under review in Japan, where it received Sakigake designation. Additional regulatory submissions are planned throughout the year.
“As the first and only approved medicine to treat the broad spectrum of narcolepsy type 1, oveporexton has the potential to fundamentally change how the disease is managed. We sincerely appreciate the support from China’s regulatory authorities in enabling an accelerated review process, helping to address a significant unmet medical need here in China,” said Yan Liu, General Manager of Takeda China. “This milestone also marks an important step for Takeda China as we expand our local presence into neuroscience with the aim to advance care for disorders that have a profound impact on people and society.”
Narcolepsy is a chronic, rare neurological disease affecting an estimated 700,000 people in China with NT1 accounting for approximately 75–80 percent of cases. NT1 is driven by orexin deficiency, making it harder to regulate sleep and wake and stabilize transitions between them. As a result, people experience a range of daytime and nighttime symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and may also experience cognitive symptoms.
NT1 typically develops between the ages of 10 and 20. The persistent, 24-hour nature of the disease can severely impact many aspects of a person’s life, including work, education and social interactions. Furthermore, NT1 may also be associated with an increased risk of traffic accidents, as well as a higher burden of anxiety, depression and related mental health conditions.1,2 Despite the substantial disease impact, limited awareness and the complexity of symptoms can contribute to misdiagnoses and an average diagnostic delay of more than 10 years.
“For years, treatment options for narcolepsy type 1 have largely relied on symptomatic therapies to manage individual symptoms,” said Professor Han Fang, Director of the Sleep Medicine Center at Peking University People’s Hospital and Director of the Peking University Sleep Research Center. “The approval of oveporexton represents a meaningful paradigm shift in narcolepsy type 1 treatment, signaling a transition from partial symptom management to a mechanism-driven approach that can help address the many symptoms evaluated in clinical studies and may support improvements in daily functioning and quality of life.”
“Oveporexton was internally discovered and developed at Takeda and is the first approved orexin agonist in China to treat narcolepsy type 1,” said Lin Wang, R&D head of global regions and head of R&D China and the Asia-Pacific region at Takeda. “Neuroscience is a strategic focus area for Takeda, and we are committed to translating innovative science into meaningful treatment options for people living with sleep-wake disorders and other areas of unmet need where orexin plays a role.”
The approval is based on the comprehensive clinical program including the global Phase 3 FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies that showed statistically significant improvements versus placebo on prespecified endpoints across the NT1 symptoms assessed. This included improvements in excessive daytime sleepiness, cataplexy and other secondary measures evaluated in the studies. Oveporexton demonstrated a safety profile consistent with previous clinical trial data to date. The most common adverse events were insomnia, urinary urgency and urinary frequency. Learn more about the Phase 3 data results here.
About ORZEYFUL (Oveporexton)
ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.
About the FirstLight and RadiantLight Phase 3 Orexin Studies
FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (twice-daily 2mg, 1mg and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (twice-daily 2mg and placebo). The primary endpoint evaluated improvement in excessive daytime sleepiness (EDS) using the Maintenance of Wakefulness Test (MWT). Secondary endpoints included the Epworth Sleepiness Scale (ESS), Weekly Cataplexy Rate (WCR), Narcolepsy Severity Scale for Clinical Trials (NSS-CT), Psychomotor Vigilance Test (PVT), Patient Global Impression of Change (PGI-C), Functional Impacts of Narcolepsy Instrument (FINI) and 36-Item Short Form Survey (SF-36), as well as treatment-emergent adverse events (TEAEs).
About Takeda’s Orexin Franchise
Takeda is the leader in orexin science with a tailored portfolio of investigational orexin agonists in pre-clinical and clinical stages for multiple-sleep wake disorders and other indications where orexin plays a role including respiration, mood and metabolism. Oveporexton is the lead orexin receptor 2 (OX2R) agonist in Takeda’s orexin franchise and has been approved by the National Medical Products Administration in China for the treatment of narcolepsy type 1 in adolescents aged 16 years and older and adults. TAK-360 is the next oral OX2R agonist in Takeda’s orexin franchise being developed for individuals with NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Additional orexin agonists are also in development, including TAK-495.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
Indication
ORZEYFUL is indicated for the treatment of narcolepsy type 1 in adolescents aged 16 years and older and adults. For important safety information, please refer to the package insert.
Contacts
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References
- Tzeng N, et al. The Risk of Hospitalization for Motor Vehicle Accident Injury in Narcolepsy and the Benefits of Stimulant Use: A Nationwide Cohort Study in Taiwan (2019). Journal of Clinical Sleep Medicine. J Clin Sleep Med. 2019 Jun 15;15(6):881-889. doi: 10.5664/jcsm.7842.
- Biscarini Francesco, et al. Co-occurrence of anxiety and depressive symptoms, suicidal thoughts, and hopelessness in patients with narcolepsy type 1 (2024). Journal of Sleep Medicine. 2024 Dec:124:141-145. doi: 10.1016/j.sleep.2024.09.023.