FDA Accepts NDA, Grants Priority Review for Oveporexton to Treat Narcolepsy Type 1

Takeda announced on February 10, 2026, that the US Food & Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review of oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1).1

Oveporexton, an investigational oral orexin receptor (OX2R)-selective agonist, addresses the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA assigned oveporexton a Prescription Drug User Fee Act (PDUFA) target date in the third quarter of 2026.

“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, MD, PhD, president of R&D at Takeda, in a statement. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling.

Patients with NT1 experience a spectrum of physical, cognitive, and psychosocial effects. Despite available treatments, most patients with this rare neurological disease continue to live with these debilitating symptoms.

The NDA is supported by pivotal phase 3 data from FirstLight and (TAK-861-3001) and RadiantLight (TAK-861-3002). Takeda had presented this phase 3 data at World Sleep 2025 in Singapore on September 8, 2026. Both FirstLight and RadiantLight met all primary and secondary endpoints.2

These trials demonstrated significant and clinically meaningful improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life, and daily functions by week 12 with either 1 mg or 2 mg of oveporexton taken twice daily (all P <.001).2 By the end of the trial, symptom levels were all near normal ranges.

The trial showed that most patients treated with oveporexton 2 mg twice a day achieved wakefulness within a normal range (≥ 20 minutes) on the Maintenance of Wakefulness Test, and nearly 85% of patients reached Epworth Sleepiness Scale scores that were comparable to healthy controls (≤ 10). Regarding cataplexy, participants had a median percent change from baseline of > 80%. Compared to placebo, the average cataplexy-free days improved from 0 days at baseline to 4 – 5 days per week at week 12.2

Furthermore, oveporexton demonstrated statistically significant changes from baseline in the narcolepsy severity score compared to placebo. More than 70% of participants reported the lowest severity levels (0 – 14). Additionally, 97% of participants treated with oveporexton reported improvements, as reflected by the self-related Patient Global Impression of Change (PGI-C) scale.2

Oveporexton significantly improved quality of life, as seen through the Short Form-36-item (SF-36) survey. Patients also experienced improvements in the EuroQol 5-Dimension 5-Level (EQ-5D-5L).2

The treatment was generally well-tolerated; common adverse events included insomnia, urinary urgency, and urinary frequency. No serious treatment-related adverse events were reported.1

The FDA had previously granted oveporexton Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1. Oveporexton had also received a Breakthrough Therapy designation from the Center for Drug Evaluation of China’s National Medical Products Administration, as well as a Sakigake designation from the Japanese Ministry of Health, Labor, and Welfare.1

“We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science,” Plump continued.1

References

1. 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. Published on February 10, 2026. Accessed on February 10, 2026. https://www.takeda.com/newsroom/newsreleases/2026/fda-accepts-nda-priority-review-oveporexton-narcolepsy-type-1/

2. Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025. Takeda. Published on September 8, 2025. Accessed on February 10, 2026. https://www.takeda.com/newsroom/newsreleases/2025/takeda-orexin-data-oveporexton-phase-3-narcolepsy-world-sleep-2025/