[{"orgOrder":0,"company":"Jazz Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Jazz Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218 ","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension\/Switch Study of Investigational Once-Nightly FT218","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daridorexant Phase 3 Results In Insomnia to be Presented at Sleep 2020","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Japan Confirms Daridorexant Dose Response in Japanese Patients with Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Syneos Health","sponsor":"Syneos Health","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Idorsia Selects Syneos Health as Commercialization Partner to Launch Daridorexant in the United States","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Syneos Health"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$632.0 million","upfrontCash":"Undisclosed","newsHeadline":"Idorsia Announces Capital Increase to Prepare for the Launch of Daridorexant and Further Fund Its Diversified Pipeline","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$592.3 million","upfrontCash":"Undisclosed","newsHeadline":"Idorsia Successfully Completes Capital Increase with Gross Proceeds of CHF 535.5 Million","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia to Present New Phase 3 Data on Daridorexant in Insomnia at Sleep 2021","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Presents New Data Supporting Clinical Benefit with Once-at-Bedtime FT218 and Preference for Once-Nightly Dosing in Patients with Narcolepsy at CHEST 2021","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Announces New Positive Data for Once-at-Bedtime FT218 for Narcolepsy and Once-Nightly Dosing Preference Among Patients and Clinicians at World Sleep 2022","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Interim Data from the Open-Label RESTORE Study at the 2022 American Academy of Neurology Annual Meeting","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Initiates Phase 3 Trial of Pitolisant in Adult Patients With Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ (sodium oxybate) Extended-Release Oral Suspension","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces Notice Of Opportunity For An Fda Hearing On The Snda For Hetlioz\u00ae In Jet Lag Disorder","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Vanda Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Favorable Ruling on Motion to Delist REMS Patent from FDA\u2019s Orange Book","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidental Dosing Errors with Immediate-Release Twice-Nightly Oxybates","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Aculys Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aculys Pharma Initiates Phase 3 Trial of Pitolisant Treating Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Aculys Pharma"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ Ahead of Anticipated Final Approval Decision","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Jefferies LLC","pharmaFlowCategory":"D","amount":"$125.0 million","upfrontCash":"Undisclosed","newsHeadline":"Avadel Pharmaceuticals Announces Pricing of Public Offering of ADSs and Series B Preferred Shares","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"RTW Investments","pharmaFlowCategory":"D","amount":"$75.0 million","upfrontCash":"Undisclosed","newsHeadline":"Avadel Pharmaceuticals Enters into Royalty Agreement with RTW Investments for up to $75 Million","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Avadel Pharmaceuticals"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Announces Accelerated Timeline for Phase 3 Intune Study in Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Completes Enrollment Of Phase 3 Registrational Intune Study In Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NLS Pharmaceutics to Proceed with Phase 3 Clinical Program (AMAZE) for Mazindol ER for the Treatment of Narcolepsy Following FDA Review and IRB Approval of the Full Study Protocol","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"NLS Pharmaceutics"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Announces US Food & Drug Administration Orphan Drug Designation for Pitolisant for Treatment of Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in LunAIRo, the First Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Apnimed"}]
Find Drugs for Sleep in Phase III Clinical Development
AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
NLS-2 (mazindol ER) is a triple monoamine reuptake inhibitor and partial Orexin-2 receptor agonist. It is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders.
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
The offering will be used for obtaining FDA approval of company's lead candidate, Lumryz, an investigational, extended-release formulation of sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy.
The financing will support the potential commercialization of Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
BF2.649 (pitolisant hydrochloride) is an antagonist/inverse agonist that binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm.