Company: TAK
Filing Date: 2025-09-08
Form Type: 6-K
Source: 0001395064-25-000130
Chunk: 2

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-09-08
Form: 6-K
Chunk 2
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, placebo-controlled studies of oveporexton (TAK-861) 1 , a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore beginning at 3:15 p.m. SGT today.

Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies met all primary and secondary endpoints demonstrating statistically significant improvement across a broad range of NT1 symptoms compared to placebo with p-values of <0.001 across all doses (twice-daily 1mg/twice-daily 2mg) at week 12. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency.

NT1 is a chronic, rare neurological disease caused by the loss of orexin neurons in the brain that results in a range of debilitating symptoms, which can severely impact every aspect of life. Currently, the standard available therapies only partially address some of the symptoms people face. As an orexin agonist, oveporexton is designed to fully address a broad range of NT1 symptoms by targeting the underlying orexin deficiency.

“Our research has shown that the loss of orexin is the cause of narcolepsy type 1, which results in symptoms like excessive daytime sleepiness and cataplexy,” said Dr. Emmanuel Mignot, M.D., Ph.D., principal investigator for the FirstLight Phase 3 study and one of the presenting authors. “Takeda’s groundbreaking efforts targeting the orexin receptor 2 in clinical studies led to positive Phase 3 results for oveporexton, bringing us a major step closer to having the first orexin therapy that addresses the underlying cause of narcolepsy type 1—with the potential of transforming the current treatment paradigm.”

Oveporexton was discovered in our Takeda labs. The Phase 3 oveporexton program is one of the largest, most comprehensive development programs for NT1. The studies investigated 14 primary and secondary endpoints over a total of 12 weeks in 273 patients across 19 countries. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (