Tag: TAKEDA

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 […]

EnsoData and Takeda to Improve Narcolepsy
Narcolepsy Sleep Pharmaceuticals

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 WUN

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 […]

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 […]