Takeda's narcolepsy treatment shows positive phase 3 results

Takeda Pharmaceutical Company Limited announced positive results from two global phase 3 studies of oveporexton (TAK-861) for narcolepsy type 1 (NT1) at the World Sleep 2025 Congress. The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies met all primary and secondary endpoints, showing statistically significant and clinically meaningful improvements in NT1 symptoms compared to placebo. Oveporexton, a potential first-in-class oral orexin receptor 2 (OX2R)-selective agonist, aims to treat NT1 by targeting orexin deficiency.

The trials, involving 273 patients across 19 countries, showed oveporexton was generally well-tolerated, with a safety profile consistent with previous studies. Common adverse events included insomnia, urinary urgency, and frequency, predominantly mild to moderate. Oveporexton is designed to restore downstream neurotransmitter activity, alleviating symptoms such as excessive daytime sleepiness and cataplexy.

Regulatory applications for oveporexton are on track to begin in fiscal year 2025, with global peak revenue potential estimated at $2-3bn+. These results are not expected to significantly impact Takeda’s full-year consolidated forecast for the fiscal year ending March 31, 2026.