Tag: NARCOLEPSY

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 […]

sleep wire
Industry News

The Sleep Wire 

EnsoData Raises $20M to Accelerate Commercialization of AI-powered Sleep Solutions EnsoData, an innovator in AI healthtech solutions, announced a $20 million Series B financing led by Questa Capital. This new capital will enable EnsoData to accelerate adoption of its AI-powered sleep medicine solutions, improving the sleep care pathway for, in […]

Takeda's ORZEYFUL Approved in China for Narcolepsy Type 1
Pharmacological 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
Narcolepsy Patient Advocacy & Awareness

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 […]

EnsoData and Takeda to Improve Narcolepsy
Narcolepsy Pharmacological

EnsoData, Takeda to Improve Narcolepsy Type 1 Diagnosis Using AI Tools and Technology

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

Breakthroughs Ahead

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 […]

Alkermes Announces Initiation of Phase 3 Brilliance Studies Evaluating Alixorexton for the Treatment of Narcolepsy Type 1 and Type 2
Pharmacological 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 […]