Central Disorders of Hypersomnolence

Alkermes Presents Additional Data From Vibrance-1 Phase 2 Study of Alixorexton in Patients with Narcolepsy Type 1 at the American Academy of Neurology (AAN) 2026 Annual Meeting
Clinical Insights Narcolepsy Sleep Pharmaceuticals

Alkermes Presents Phase 2 Alixorexton Data in Narcolepsy Type 1 at AAN 2026

Alkermes plc presents new data from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at the American Academy of Neurology (AAN) 2026 Annual Meeting, taking place April 18-22, 2026 in Chicago. Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment […]

Narcolepsy Network Announces Addition of Two New Board Members
Central Disorders of Hypersomnolence Patient Advocacy

Narcolepsy Network Announces Addition of Two New Board Members

Narcolepsy Network, a national non-profit organization for people living with narcolepsy and idiopathic hypersomnia (IH), is proud to announce the appointment of Desireé Gorbea-Finalet and Mike Heil to its Board of Directors. Both new members live with narcolepsy and will bring fresh perspectives and deep advocacy experience to the organization as it prepares to […]

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2
Narcolepsy Research/Studies Sleep Pharmaceuticals

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2

Alkermes plc, announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development […]

Harmony Biosciences Receives U.S. FDA Approval for WAKIX (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
Narcolepsy Sleep Pharmaceuticals

Harmony Biosciences Receives FDA Approval for WAKIX for the Treatment of Cataplexy in Pediatric Narcolepsy

Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]

U.S. Food and Drug Administration 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
Narcolepsy Sleep Pharmaceuticals

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 […]

U.S. Food and Drug Administration 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
Sleep Pharmaceuticals Industry News Narcolepsy

Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025

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) […]