Japan approves Viatris sleep drug Wakix for narcolepsy and sleep apnea

Viatris Inc. (Nasdaq: VTRS) announced that Japan's Ministry of Health, Labour and Welfare has approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome and for narcolepsy types 1 and 2, according to a company press release dated Sept. 16, 2026.

Wakix is described as the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications. The drug is not classified as a controlled substance and has been designated as an orphan drug in Japan for narcolepsy.

The approval was supported by domestic Phase 3 clinical trials in Japan and multiple international studies evaluating Wakix in patients with narcolepsy and in patients with obstructive sleep apnea experiencing excessive daytime sleepiness despite continuous positive airway pressure therapy.

Wakix is an orally administered drug that modulates the brain's sleep-wake pathways. It was discovered by Bioprojet of Paris, France, and has previously received approval for narcolepsy in more than 38 countries, including the United States and countries across Europe. It has also been approved for sleep apnea-related excessive daytime sleepiness in more than 29 European countries. Viatris holds a license for the drug in the Japan market only.

"This milestone marks an important advancement for sleep medicine in Japan and brings forward a treatment option that is not classified as a controlled substance," said Philippe Martin, Viatris Chief R&D Officer.

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