Takeda’s Orexin Narcolepsy Drug TAK-861 Poised for Phase III Trials After Promising Results

1. Positive Phase 2b Results: Takeda's oral orexin receptor 2 agonist, TAK-861, demonstrated statistically significant and clinically meaningful improvements in wakefulness and sleepiness in patients with narcolepsy type 1 (NT1) in a Phase 2b trial.
2. Phase III Trials Planned: Based on these results, Takeda plans to rapidly initiate global Phase III trials of TAK-861 in NT1 in the first half of fiscal year 2024.
3. Safety Profile: TAK-861 was found to be generally safe and well-tolerated in both NT1 and NT2 trials, with no treatment-related serious adverse events, hepatotoxicity, or visual disturbances reported.
4. Breakthrough Therapy Designation: The U.S. FDA granted Breakthrough Therapy designation to TAK-861 for the treatment of excessive daytime sleepiness (EDS) in NT1.
5. Market Potential: The market for narcolepsy type 1 drugs is estimated to be worth over $3 billion.
6. Orexin Franchise: Takeda is advancing multiple orexin agonists in various patient populations, including TAK-360 for narcolepsy type 2 and idiopathic hypersomnia, and danavorexton (TAK-925) for moderate to severe obstructive sleep apnea.
7. Competitive Landscape: Other companies, such as Alkermes and Jazz Pharmaceuticals, are also developing orexin-targeting therapies for sleep disorders.