Takeda (TAK.US) Class 1 New Drug Alverine Tablets is intended to be included in priority review for use in patients with type 1 narcolepsy.

The official website of China's National Medical Products Administration Drug Evaluation Center recently announced that the application for the marketing of the class 1 new drug Oveporexton tablets (TAK-861 tablets) filed by Takeda (TAK.US) is planned to be included in priority review, for the treatment of type 1 narcolepsy (NT1) patients aged 16 and above. Public information shows that this is an orally administered selective orexin 2 receptor (OX2R) agonist developed by Takeda. Two key phase 3 studies of this product for the indication of NT1 have achieved all major and minor endpoints. Type 1 narcolepsy (NT1) is a rare chronic central nervous system disorder characterized by a significant loss of orexin neurons in patients, leading to low levels of orexin peptides in the brain and cerebrospinal fluid. NT1 patients often experience excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), nocturnal sleep disturbances, hallucinations before falling asleep and upon waking, and sleep paralysis, among other clinical symptoms. Oveporexton tablets are an investigational selective OX2R agonist that selectively stimulates OX2R to restore its signaling and improve NT1 caused by orexin deficiency. In July 2025, Takeda announced that two phase 3 studies of Oveporexton tablets for NT1 had achieved all major and minor endpoints. Both primary and secondary endpoints measured in the studies showed significant and statistically meaningful improvements in patients' wakefulness, daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life, and daily functioning. Various clinical indicators of observed symptoms have improved to near-normal levels.