The Magazine for Sleep Professionals
Friday, August 28, 2026
Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat […]
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. […]
The U.S. Food and Drug Administration today approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first to […]
Takeda China announced that the National Medical Products Administration of China has approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adolescents aged 16 years and older and adults. Oveporexton is the first oral orexin receptor 2 (OX2R)-selective agonist approved in China and is the […]
The 40th annual SLEEP meeting drew its usual crowd of clinicians, researchers, technologists, and industry representatives to Baltimore — but this year’s meeting felt different in at least one important way. The pharmaceutical presence on the exhibit floor and in sponsored symposia has grown substantially over the past decade, and […]
New data presented by Takeda at SLEEP 2026 this week continues to build the case for oveporexton (TAK-861) as a potential disease-modifying treatment for narcolepsy type 1 (NT1). Oveporexton is designed to address the root cause of the disease, targeting the underlying orexin deficiency responsible for NT1. Results from two pivotal […]
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 […]
Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore. Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]
EnsoData has announced a collaboration with Takeda to jointly develop and validate AI-based polysomnography (PSG) algorithms to support more accurate and scalable diagnosis of narcolepsy type 1 (NT1). Upon successful validation and regulatory clearance, EnsoData will pursue the clinical availability and release of AI algorithms to enable future access, use, […]
Narcolepsy research is entering an exciting phase, with promising new treatments and discoveries on the horizon. Because narcolepsy symptoms can cause daily disruptions, affecting everything from work to relationships, having effective treatments makes a meaningful difference in improving quality of life. At Wake Up Narcolepsy (WUN), we’re committed to not […]
