The China Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) recently announced that the marketing application for Takeda Pharmaceutical Co Ltd's (TAK.US) new Class 1 drug, Oveporexton tablets (TAK-861 tablets), has been recommended for priority review. This drug is intended for the treatment of patients aged 16 and above with Type 1 Narcolepsy (NT1).

Public information indicates this is an oral selective orexin receptor 2 (OX2R) agonist developed by Takeda. Two pivotal Phase 3 studies for the NT1 indication have already met all primary and secondary endpoints.

Type 1 Narcolepsy (NT1) is a rare, chronic central nervous system disorder characterized by a significant loss of orexin-producing neurons, leading to low levels of orexin neuropeptides in the brain and cerebrospinal fluid. Patients with NT1 often experience clinical symptoms such as excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hypnagogic and hypnopompic hallucinations, and sleep paralysis.

Oveporexton tablets are an investigational selective OX2R agonist designed to selectively stimulate the OX2R to restore its signaling and improve NT1 symptoms caused by orexin deficiency.

In July 2025, Takeda announced that two Phase 3 studies of Oveporexton tablets for NT1 had achieved all primary and secondary endpoints. Measurements across these endpoints demonstrated statistically significant and substantial improvements for patients in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life, and daily functioning. The observed clinical metrics for a range of symptoms improved to near-normal levels.