Takeda Announces FDA Acceptance of Oveporexton NDA for NT1

Takeda announced that the U.S. Food and Drug Administration has accepted its New Drug Application and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). The FDA has assigned a Prescription Drug User Fee Act goal date in the third quarter of this year, positioning Takeda to potentially deliver the first approved orexin agonist therapy for people living with NT1.

Andy Plump, President of R&D at Takeda, said the FDA’s acceptance of the NDA represents an important step for people with narcolepsy type 1, underscoring the significant unmet need for therapies that address the underlying orexin deficiency and marking progress toward a potential shift in the treatment paradigm through Takeda’s orexin science program.

Clinical Trial Basis

The NDA is supported by a comprehensive Phase 3 development program, including the global FirstLight (TAK-861-3001, NCT06470828) and RadiantLight (TAK-861-3002) studies. Across these trials, oveporexton demonstrated statistically significant and clinically meaningful improvements in wakefulness, excessive daytime sleepiness, cataplexy, attention, quality of life, and daily functioning. Improvements across multiple endpoints approached near-normal ranges, reflecting a broad and consistent treatment effect. Oveporexton was generally well tolerated, with the most common adverse events reported as insomnia, urinary urgency, and urinary frequency, consistent across studies.

About Oveporexton

Oveporexton is an investigational, once-daily oral orexin receptor 2–selective agonist designed to address the underlying cause of NT1. Narcolepsy type 1 is driven by a loss of orexin signalling in the brain, resulting in excessive daytime sleepiness and cataplexy. By restoring orexin signalling rather than solely managing symptoms, oveporexton represents a differentiated therapeutic approach.

Oveporexton has received multiple regulatory designations reflecting its potential clinical impact, including Breakthrough Therapy designation from the U.S. FDA for excessive daytime sleepiness in NT1, a similar designation from China’s National Medical Products Administration, and Sakigake designation from Japan’s Ministry of Health, Labour and Welfare.

Takeda stated that the NDA filing is not expected to have a material impact on its consolidated financial forecast for the fiscal year ending March 31, 2026.

Path Forward

Beyond oveporexton, Takeda continues to advance its orexin-focused development pipeline. TAK-360, a next-generation oral OX2R agonist, is being developed for narcolepsy type 2 and idiopathic hypersomnia. Additional orexin agonists, including TAK-495, remain in earlier stages of development. Collectively, these programs support Takeda’s leadership in orexin science and its potential to expand treatment options across multiple sleep-wake disorders.

About Narcolepsy Type 1

Narcolepsy type 1 is a rare, chronic neurological disorder that significantly impairs daily functioning. In addition to excessive daytime sleepiness and sudden loss of muscle tone, patients often experience long-term cognitive, emotional, and social challenges. Despite available treatments, many individuals continue to have persistent symptoms, highlighting the ongoing need for more effective and targeted therapies.

References

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, 10 February 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｜Takeda Pharmaceuticals

A Study of TAK-861 for the Treatment of Narcolepsy Type 1, ClinicalTrials.gov ID NCT06470828, https://clinicaltrials.gov/study/NCT06470828

A Study of TAK-861 in People with Narcolepsy Type 1, ClinicalTrials.gov ID NCT06505031, https://clinicaltrials.gov/study/NCT06505031