- Secondary and Exploratory Endpoint Results from Phase 3 Studies Presented at SLEEP 2026 Underscore Improvements with Oveporexton Across a Broad Range of Daytime and Nighttime Symptoms
- Takeda is on Track to Bring the First and Only Orexin Agonist to People Living with Narcolepsy Type 1 with Regulatory Submissions Under Review
(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today presented additional results from two pivotal studies at SLEEP 2026, showing oveporexton (TAK-861), an oral orexin receptor 2 (OX2R)-selective agonist, improved daily functioning as well as cognitive and sleep-related symptoms associated with narcolepsy type 1 (NT1).1,2,3 Oveporexton is designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. These data, along with previously disclosed Phase 3 results, demonstrated improvement across the broad disease spectrum, supporting the potential of oveporexton to redefine the standard of care for NT1.4
"Narcolepsy type 1 is a 24-hour disease driven by orexin deficiency, and while excessive daytime sleepiness and cataplexy are the most recognized symptoms, many people experience additional bothersome symptoms such as cognitive difficulties and disrupted nighttime sleep," said Emmanuel Mignot, M.D., Ph.D., principal investigator for the FirstLight (TAK-861-3001) Phase 3 study. "Oveporexton has demonstrated significant improvement across a broad range of NT1 symptoms, daily functioning and quality of life with the potential to shift disease management beyond incremental symptom relief.”
The presentations highlighted results from secondary and exploratory endpoints from two global, multicenter, placebo-controlled studies—FirstLight (TAK-861-3001; twice-daily 2mg, 1mg and placebo) and RadiantLight (TAK-861-3002; twice-daily 2mg and placebo)—including:
Functioning: At all doses, oveporexton significantly improved daily functioning at week 12 compared to placebo (p<0.001) across the six domains of the Functional Impacts of Narcolepsy Instrument (FINI). Most patients reached or exceeded the published normative domain thresholds, underscoring oveporexton’s ability to allow individuals to manage their everyday lives.5 FINI reflects the domains that are of highest impact for NT1 including tiredness, cognitive functioning, cataplexy, social activities, everyday activities and everyday responsibilities.
Cognition: Oveporexton improved cognitive symptoms associated with NT1 compared to placebo, as measured using objective neuropsychological tests of attention, executive function and memory along with patient-reported measures. On the FINI Cognitive Function domain, approximately 70% of patients across all doses reported no significant cognitive difficulties compared to approximately 15% of patients in the placebo arm.
Nighttime Sleep: Exploratory endpoints demonstrated that oveporexton improved quality of sleep across both studies. Across all doses, most patients reported no hallucinations or sleep paralysis and most patients on the 2/2mg dose reported meaningful reductions in disturbed nighttime sleep from baseline. Additionally, the timing and pattern of rapid eye movement (REM) sleep shifted toward those seen in healthy controls.
"Narcolepsy type 1 is not defined by a single symptom, which is why we designed a comprehensive Phase 3 program to evaluate the effect of oveporexton on the broad disease impact,” said Sarah Sheikh, M.Sc., B.M., B.Ch., MRCP, Head, Neuroscience Therapeutic Area Unit and Global Development at Takeda. “We are grateful to the patients, caregivers and healthcare providers who have been a part of this journey. With oveporexton under review by multiple regulatory agencies, we are on the cusp of bringing the first and only orexin agonist to the narcolepsy type 1 community, with the potential to redefine the standard of care if approved.”
Takeda will present additional data at the conference, including pooled analyses from previously presented Phase 3 results, data evaluating the impact of oveporexton in reducing microsleeps and an evaluation of the holistic symptom impact of NT1 in the United States.
About Oveporexton (TAK-861)
Oveporexton (TAK-861) is an investigational 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 broad spectrum of daytime and nighttime symptoms. The United States Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for oveporexton, with a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Regulatory submissions for oveporexton are also under review in China and Japan, with additional submissions planned throughout the year. Oveporexton is an investigational compound that has not been approved for use by any regulatory authority.
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). More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study.
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.
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References
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 The topline results of these studies were shared on September 8, 2025, in “Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025.”
5 Crawford S, et al. Sleep 2024;47(suppl 1):A288.
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