Viatris wins Japanese approval for Wakix in narcolepsy and obstructive sleep apnoea
Viatris has received Japanese approval for Wakix to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea.
Wakix, or pitolisant, is the first histamine H3 receptor antagonist and inverse agonist approved in Japan for these indications and provides a non-stimulant approach to improving wakefulness.
The approval expands the international reach of Wakix and introduces a new mechanism of action for patients in Japan with disabling excessive daytime sleepiness.
Field | Content |
Alert Type | Approval |
Drug Name | Pitolisant |
Brand Name | Wakix |
Company | Viatris |
Regulatory Authority | Japanese regulatory authorities |
Approval Type | Marketing approval |
Indication | Narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea |
Therapy Area(s) | Neurology; sleep medicine |
Technology or Modality | Histamine H3 receptor antagonist/inverse agonist |
Geography | Japan |
What Happened | Viatris received Japanese approval for Wakix for narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea. |
Why It Matters | Wakix introduces a first-in-class, non-stimulant wake-promoting mechanism to the Japanese market for patients affected by significant daytime sleepiness. |
Supporting Context | Pitolisant enhances histaminergic activity in the brain through H3 receptor antagonism and inverse agonism and is already used in other international markets. |
Key Takeaway | Wakix becomes Japan's first approved H3 receptor antagonist/inverse agonist for narcolepsy and excessive daytime sleepiness associated with OSA. |
What to Watch | Japanese commercial launch, reimbursement, prescribing patterns and adoption across sleep-medicine centres. |
Primary Source | Viatris |
Relevant Date | 16 September 2026 |
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