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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.

BioWorld Regulatory Neurology/psychiatric Small molecule Asia-Pacific China Japan U.S. FDA MHLW NDA NMPA

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