Takeda presents positive data from Phase III oveporexton study

Japan’s largest drugmaker Takeda (TYO: 4502) has presented data from two global Phase III double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), at the World Sleep 2025 Congress in Singapore.

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.

The company noted that Takeda is the leader in Orexin Science and is on track to submit global regulatory applications starting in fiscal year 2025.