- 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

OSAKA, Japan & CAMBRIDGE, Mass. -- (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.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260615651327/en/

CONTACT:

Investor Relations

Christopher O’Reilly
takeda.ir.contact@takeda.com

Media Relations

Tsuyoshi Tada (Tokyo)
Toiawase_kouhou@takeda.co.jp

Kristi Bond (Boston)
Media_relations@takeda.com