By: IPP Bureau
Last updated : August 25, 2026 6:02 pm
The company is preparing for the launch of Orzeyful in Japan, with the aim of making the treatment available to patients as soon as possible
Takeda has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adults, marking the third regulatory approval for the therapy globally.
Orzeyful is an oral orexin receptor 2 agonist discovered at Takeda’s laboratories in Japan.
The company said the therapy is currently the only treatment approved in Japan specifically targeting the underlying orexin deficiency associated with narcolepsy type 1, rather than addressing individual symptoms.
Takeda is preparing for the launch of Orzeyful in Japan, with the aim of making the treatment available to patients as soon as possible.
“Our discovery of the first orexin agonist is a successful representation of Japan-originated science that will directly impact people around the world living with narcolepsy type 1,” said Julie Kim, President and CEO, Takeda.
She said Orzeyful could help redefine the treatment of narcolepsy type 1 and represents an important validation of the company's broader orexin research strategy.
Narcolepsy type 1, also known as narcolepsy with cataplexy, is a rare chronic neurological disorder associated with a deficiency of orexin, a neurotransmitter involved in regulating wakefulness and sleep.
The Japanese approval was supported by data from Takeda’s clinical development programme, including the global Phase III FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) trials.
The studies found that oveporexton improved excessive daytime sleepiness, cataplexy and other secondary symptoms compared with placebo.
The approval in Japan follows earlier authorisations for Orzeyful in China and the United States, making Japan the therapy’s third approved market.
In the US, however, the classification of Orzeyful as a controlled substance remains under review by the Drug Enforcement Administration (DEA).