Japan Approves Viatris' WAKIX (Pitolisant), First Histamine H3 Receptor Antagonist for Narcolepsy and OSA-Related Daytime Sleepiness
核心洞察
Japan's Ministry of Health, Labour and Welfare approved WAKIX (pitolisant) for narcolepsy (搜索) types 1 and 2 and for excessive daytime sleepiness (搜索) associated with obstructive sleep apnea syndrome (搜索).
WAKIX becomes the first histamine H3 receptor (搜索) antagonist/inverse agonist approved in Japan for these indications and is not classified as a controlled substance.
Approval was supported by positive domestic Phase 3 trial data in Japan plus international studies in narcolepsy (搜索) and in OSAS patients with residual sleepiness on CPAP.
Japan's Ministry of Health, Labour and Welfare has granted approval for WAKIX (pitolisant) for the treatment of excessive daytime sleepiness (搜索) (EDS) associated with obstructive sleep apnea syndrome (搜索) (OSAS) in patients receiving treatment for airway obstruction, and for narcolepsy (搜索) type 1 and type 2, with and without cataplexy (搜索). Viatris Inc. (Nasdaq: VTRS) announced the approval on Sept. 16, 2026, describing WAKIX as the first histamine H3 receptor (搜索) antagonist/inverse agonist approved in Japan for these indications.
"As Japan's first approved histamine H3 receptor (搜索) antagonist/inverse agonist for these conditions, WAKIX offers a much-needed novel treatment option for patients," said Philippe Martin, Viatris Chief R&D Officer. "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. We continue to strengthen Viatris' innovative medicines portfolio in this strategically important market by investing in differentiated therapies for patients."
Mechanism and Dosing Profile
WAKIX (pitolisant) is an orally administered histamine H3 receptor (搜索) antagonist/inverse agonist that modulates the brain's sleep–wake pathways. The drug is not classified as a controlled substance and has been designated as an orphan drug in Japan for narcolepsy (搜索).
The compound was discovered by Bioprojet (Paris, France) and is licensed to Viatris for the Japan market only. WAKIX is a registered trademark of Bioprojet Europe, Ltd., licensed to Viatris.
Unmet Need in Sleep Medicine
According to Viatris, EDS is a shared and clinically significant symptom of both OSAS and narcolepsy (搜索) and remains an area of unmet medical need in Japan. In patients with OSAS, EDS can adversely affect daily functioning, work productivity, and quality of life and may persist despite treatment of airway obstruction.
Narcolepsy (搜索) is a chronic neurological disorder characterized by EDS and an impaired ability to maintain wakefulness. The condition can also have a significant impact on patients' daily lives and is often associated with delays in diagnosis. Narcolepsy includes type 1, which is associated with cataplexy (搜索) (sudden muscle weakness), and type 2, which is not associated with cataplexy.
Evidence Base and Global Regulatory History
The approval of WAKIX in Japan was supported by positive data from domestic Phase 3 clinical trials in Japan as well as multiple international clinical studies evaluating the drug in patients with narcolepsy (搜索) and in patients with OSAS experiencing EDS despite treatment with continuous positive airway pressure (CPAP) therapy.
Outside Japan, WAKIX has previously received approvals for narcolepsy (搜索) in more than 38 countries, including the United States and countries across Europe, and for OSAS-related excessive daytime sleepiness (搜索) in more than 29 European countries.
Viatris is a global healthcare company headquartered in the United States, with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Its portfolio spans generics, value-added medicines, established brands, and innovative medicines addressing areas of significant unmet need.