Harmony Biosciences, has announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, […]
Tag: orexin agonist
Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025
Eisai Co., Ltd. announced today that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086 have been presented at the World Sleep 2025 congress, held in Singapore from September 5 to 10. These data demonstrate that once-daily dosing of […]
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) […]
Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (“XWPharma”) together announced that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB receptor agonist, for all indications, including the treatment of sleep disorders, such as […]
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 […]
Nxera Pharma Receives $4.8M Milestone Payment from Centessa for ORX142 Trial
Nxera Pharma Co., Ltd. today announces that it will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals pursuant to its research collaboration with Centessa. The milestones were achieved as Centessa initiated clinical development of ORX142, its second novel orexin receptor 2 (OX2R) agonist, following the recent clearance of an […]
Takeda Reports Positive NT1 Trial Results for Oveporexton
Takeda announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to restore orexin signaling to address the underlying orexin deficiency that causes NT1. Results demonstrated […]
Centessa Receives FDA Clearance for Phase 1 Clinical Trial of Promising Narcolepsy Treatment
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist […]
Harmony Biosciences to Develop Potential Best-in-Class Oral Orexin-2 Receptor Agonist for Narcolepsy
Harmony Biosciences Holdings, Inc. has announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists […]
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 […]












