US FDA approves Takeda's sleep disorder pill

Takeda Pharmaceutical

05/08/2026 22:44

Aug 5 (Reuters) - The FDA has approved Takeda Pharmaceuticals' 4502.T oral drug for narcolepsy, the U.S. health regulator said on Wednesday, backing the first treatment that targets all the symptoms of the rare sleep disorder.

Here are more details:
The U.S. Food and Drug Administration granted approval to Orzeyful, a twice-daily pill that works by directly targeting the loss of orexin signaling that causes the disease. 
Narcolepsy type 1 is a rare sleep disorder affecting an estimated 1 in 2,000 people in the United States, the company said. It is caused by the loss of brain cells that produce orexin, a chemical messenger that regulates wakefulness, sleep, and muscle tone.
The approval was based on data from two studies in which patients taking Orzeyful showed improvements in their ability to stay awake during the day compared with those receiving placebo.
Prior to Wednesday's nod, no medicine had been approved for narcolepsy type 1 as a unified disorder, and none acted on the orexin system, the FDA said. 

 (Reporting by Sneha S K in Bengaluru)
 ((Sneha.SK@thomsonreuters.com;))