The thought of histamines might conjure up images of itchy hives or the tickling sensation just before a sneeze, but scientists have come to realize there is much more to histamines than their connection to allergies. Recent research reveals that histamines play a vital role in wakefulness. Produced by brain […]
Narcolepsy
Accelerating Narcolepsy Research Together
Since its inception in 2008, Wake Up Narcolepsy (WUN) has donated over $1.39 million to narcolepsy research. We are a nonprofit organization committed to advancing narcolepsy awareness, education, and research. A large part of our mission involves raising and allocating funding to develop improved treatments and ultimately, find a cure. […]
FDA Approves LUMRYZ for Pediatric Narcolepsy Treatment
Avadel Pharmaceuticals plc announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. “This approval represents an important milestone for the narcolepsy community, […]
Wakix Granted FDA Approval for Pediatric Patients
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 excessive daytime sleepiness (EDS) in pediatric patients six years of age and older with narcolepsy. The FDA separated the submission into two sNDAs […]
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 […]
Potential Next Generation Dual Orexin Agonist for Narcolepsy in Development
NLS Pharmaceutics Ltd., a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system (“CNS”) disorders, announced that NLS has entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company (“Aexon Labs”), […]
Jazz Pharmaceuticals Presents Latest Advancements at World Sleep 2023
Jazz Pharmaceuticals plc announced that the Company and its partners will present 14 abstracts from across its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, held October 20-25 in Rio de Janeiro, Brazil. The oral presentations include findings from the real-world TENOR study, […]
Jazz Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023
Jazz Pharmaceuticals plc announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and […]
Promising Results for Narcolepsy Type 1 Treatment, but Safety Concerns Arise
Takeda announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine. These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1. The […]













