Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1

− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) − Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role − ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwideOSAKA, Japan & CAMBRIDGE, Mass. — Takeda ( TSE:4502/NYSE:TAK) announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1.

“We’re excited at the potential to fundamentally change how NT1 is managed across Japan and China,” said Giles Platford, president, International, Takeda. “We’ve heard from patients how ORZEYFUL has improved their daily functioning and quality of life, enormously meaningful outcomes for a condition known to impact many aspects of a person’s life, including work, education and social interactions.”^1,2,3,4,5 NT1 is a chronic, rare neurological disease driven by orexin deficiency. People experience a range of symptoms including excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms. Many patients experience challenges that may affect their quality of life and limit their independence. People with narcolepsy have approximately twice the rate of healthcare resource utilization compared with controls, including more frequent emergency department visits, hospitalizations, outpatient appointments and physician consultations.^6,7,8 ORZEYFUL is the first therapy designed to restore orexin signaling and address the biological cause of NT1. This mechanism represents a potential paradigm shift from symptom management to a disease-targeted treatment. Landmark Phase 3 studies in people with NT1 demonstrated ORZEYFUL improved the full range of NT1 symptoms and quality of life compared with placebo⁹. Results showed consistent, clinically meaningful and statistically significant improvements with ORZEYFUL compared to placebo in wakefulness, sleepiness, cataplexy, disease severity and quality of life measures (p-values of <0.001) across doses over 12 weeks. These improvements were observed at the earliest assessed timepoint for each measure and were sustained throughout the duration of the studies. ORZEYFUL was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common side effects include insomnia, urinary urgency, urinary frequency and excessive saliva.

ORZEYFUL (oveporexton) is an oral orexin receptor 2 (OX2R) agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency associated with narcolepsy type 1 (NT1). By activating OX2Rs, ORZEYFUL promotes wakefulness and reduces abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy (sudden and temporary loss of muscle tone), and address a range of daytime and nighttime symptoms as evaluated in clinical studies and consistent with the approved label.

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 regulatory bodies in China for the treatment of narcolepsy type 1(NT1) in adolescents aged 16 and older and adults as well as in the United States and Japan for adults with NT1. The company is also investigating other oral orexin agonists, including TAK-360 for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as well as TAK-495.

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.

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1. Plazzi G, Dauvilliers Y, Pizza F, et al. Effect of the Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) on Functional Impacts of Narcolepsy Type 1: Results from Two Phase 3 Studies. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.
2. Pizza F, Dauvilliers Y, Del Rio Villegas R, et al. Oveporexton (TAK-861) Improves Cognitive Symptoms in Patients with Narcolepsy Type 1: Results from Two Randomized, Placebo-controlled Phase 3 Trials. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.
3. Barateau L, Gong Y, Dauvilliers Y, et al. Effects of Treatment with Oveporexton, an Orexin Receptor 2 Agonist, on Sleep in People with Narcolepsy Type 1: Phase 3 Results. Presented at: SLEEP 2026; 14-17 June 2026; Baltimore, MD.
4. Maski K, Steinhart E, Williams D, et al. Listening to the patient voice in narcolepsy: diagnostic delay, disease burden, and treatment efficacy. J Clin Sleep Med. 2017;13(3):419-425.
5. Flores NM, Villa KF, Black J, et al. The humanistic and economic burden of narcolepsy. J Clin Sleep Med. 2016;12(03):401-407.
6. Thorpy MJ and Hiller G. The medical and economic burden of narcolepsy: implications for managed care. Am Health Drug Benefits. 2017;10(5):233-241.
7. Jennum P, Ibsen R, Petersen ER, et al. Health, social, and economic consequences of narcolepsy: a controlled national study evaluating the societal effect on patients and their partners. Sleep Med. 2012;13(8):1086–93.
8. Black J, Reaven NL, Funk SE, et al. The Burden of Narcolepsy Disease (BOND) study: health-care utilization and cost findings. Sleep Med. 2014 May;15(5):522–9.
9. Dauvilliers Y, Mignot E, Antczak J, et al. Oveporexton for Narcolepsy Type 1: Results from Two Phase 3 Trials. New England Journal of Medicine 2026.

Contacts

Christopher O’Reilly

Tsuyoshi Tada

Hannah Badri