Takeda Pharmaceutical Company has announced updates on two ongoing neuroscience clinical trials: a Phase 2 study of TAK-360 for narcolepsy and a Phase 3 study of vortioxetine for major depressive disorder in Japanese teens. Both trials are randomized, triple-blind, and currently recruiting patients.
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07646678 |
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia |
RECRUITING | PHASE2/PHASE3 |
| NCT07633301 |
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) |
RECRUITING | PHASE2 |
| NCT06952699 |
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) |
RECRUITING | PHASE2 |
| NCT06812078 |
A Study of TAK-360 in Adults With Idiopathic Hypersomnia |
RECRUITING | PHASE2 |
