Tag: NARCOLEPSY TYPE 1

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 […]

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) […]

3 Powerful Takeaways from the 2025 WUN National Summit
WUN Advocacy/Awareness Narcolepsy

The Power of WUN

Attendees traveled from near and far to join us in person and online for the 2025 Wake Up Narcolepsy National Summit in Raleigh-Durham, N.C. Hosted in a different city each year, the summit provides a place where industry professionals, clinicians, individuals with narcolepsy, and family members can come together and […]

Research/Studies Narcolepsy

Illuminating Narcolepsy’s Neural Pathways

Sleep and wakefulness are carefully balanced by a network of brain regions. Yet for many years, scientists couldn’t pinpoint exactly which neurons regulated sleep state transitions. New research tools and a deeper understanding of brain signaling have led to new discoveries in dopamine and norepinephrine signaling, offering novel insights into […]

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

Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1

Alkermes plc today announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as […]

takeda oral orexin narcolepsy type 1
Sleep Pharmaceuticals Narcolepsy Product/Vendor Updates

First Global Phase 3 Trials of Narcolepsy Type 1 Oral Orexin Agonist

Takeda has announced positive topline results from a randomized, double-blind, placebo-controlled, multiple-dose Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence with significant unmet need despite multiple approved therapies. It is […]