Tag: OVERPOREXTON

FDA Approves Takeda’s ORZEYFUL for Narcolepsy Type 1
Industry News Narcolepsy Pharmacological Sleep Disorders

U.S. FDA Approves Takeda’s ORZEYFUL (oveporexton), the First and Only Orexin Agonist for Narcolepsy Type 1

Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. […]

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Takeda's ORZEYFUL Approved in China for Narcolepsy Type 1
Narcolepsy Pharmacological

U.S. FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]

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