CSBio CSBio

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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":"Phase III"},{"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":"Phase III"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NLS Pharmaceutics Announces Completion of Open Label Extension Study with Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Sumitomo","sponsor":"Jazz Pharmaceuticals","pharmaFlowCategory":"D","amount":"$1,140.0 million","upfrontCash":"$50.0 million","newsHeadline":"Jazz Pharmaceuticals and Sumitomo Pharma Announce Exclusive License Agreement to Develop and Commercialize DSP-0187, a Potent, Highly Selective Oral Orexin-2 Receptor Agonist","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase I"},{"orgOrder":0,"company":"Axsome Therapeutics","sponsor":"Pharmanovia","pharmaFlowCategory":"D","amount":"$167.0 million","upfrontCash":"$66.0 million","newsHeadline":"Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi\u00ae (solriamfetol) in Europe","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Requests Final FDA Approval for LUMRYZ\u2122 (sodium oxybate) Extended Release Oral Suspension","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"RARE-X","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Zevra Therapeutics Announces Collaboration with RARE-X and the Sleep Consortium as Founding Member of New Sleep Data Initiative","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Bioprojet Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bioprojet: WAKIX\u00ae (pitolisant) Receives Approval for The Treatment of Narcolepsy in Children Over 6 Years of Age, a Rare, Under-Diagnosed Condition","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"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":"Phase III"},{"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":"Phase III"},{"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":"Phase III"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NLS Pharmaceutics Announces Open Label Extension Study Six-Month Data for Quilience(R) (Mazindol ER) in the Treatment of Narcolepsy Type 1 and Type 2","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"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":"Phase III"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"IND Enabling"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ\u2122 (sodium oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Approves Quviviq (daridorexant) for The Management of Adult Patients with Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NLS Pharmaceutics Receives Green Light from the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"IND Enabling"},{"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":"Phase III"},{"orgOrder":0,"company":"Avadel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adults Living with Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Launches Quviviq (Daridorexant) In Switzerland \u201c A First-In-Class Treatment For Chronic Insomnia Disorder To Improve Both Nighttime Symptoms And Daytime Functioning","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NLS Pharmaceutics Announces Positive Safety Data From In Vitro CYP450 and Transporter Mediated Drug-Drug Interaction Studies of Mazindol","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"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":"Phase III"},{"orgOrder":0,"company":"Elixinol Wellness","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GLOBAL CBD BRAND ELIXINOL WELLNESS INTRODUCES TWO INNOVATIVE SLEEP* PRODUCTS","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"RareStone Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China NMPA Approves RareStone's Pitolisant (Wakix) for the Treatment of Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Bioprojet Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bioprojet: European Marketing Authorisation for OZAWADE\u2122","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"RareStone Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix\u00ae (pitolisant) for narcolepsy with and without cataplexy in China","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Announces its Insomnia Medication, QUVIVIQ (daridorexant), is Now Covered by CVS","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Fortrea","sponsor":"Incannex Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Incannex Engages Fortrea to Manage its FDA IND Opening Phase 2\/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase I"},{"orgOrder":0,"company":"RespireRx Pharmaceuticals","sponsor":"ResolutionRx","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RespireRx Pharmaceuticals Inc. and ResolutionRx Ltd Enter into Bilateral Agreements to Establish ResolutionRx Ltd as an Operating Company","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"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":"Phase III"},{"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":"Phase III"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces Interim Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Ab Initio Pharma","sponsor":"ResolutionRx","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RespireRx Pharmaceuticals Inc.\u2019s Subsidiary ResolutionRx Ltd Enters into Master Services Agreement for Dronabinol Manufacturing and Related Services","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Harmony Biosciences Announces Topline Data from Phase 3 Intune Study Evaluating Pitolisant in Patients with Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"},{"orgOrder":0,"company":"Centessa Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Centessa Pharmaceuticals Announces Preclinical Data Supporting ORX750\u2019s Potential as a Best-in-Class Oral OX2R Agonist for the Treatment of Narcolepsy and Other Sleep-Wake Disorders","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"IND Enabling"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"PsychoGenics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"PsychoGenics Announces Exclusive Global License for an IND-Ready ENT1 Inhibitor for the Treatment of Neuropsychiatric Disorders","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"SWITZERLAND","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Undisclosed","graph2":"Preclinical"},{"orgOrder":0,"company":"NLS Pharmaceutics","sponsor":"Aexon Labs","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"NLS Pharmaceutics Announces Exclusive Option Agreement to Develop and Commercialize Next Generation Dual Orexin Agonist Platform of Aexon Labs, Inc.","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"SWITZERLAND","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Undisclosed","graph2":"Preclinical"},{"orgOrder":0,"company":"Apnimed","sponsor":"Shionogi","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Apnimed Announces Launch of Joint Venture with Shionogi to Develop Novel Pharmacologic Therapies for Obstructive Sleep Apnea and Other Sleep Disorders","therapeuticArea":"Sleep","highestDevelopmentStatus":"Discovery","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Discovery"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in SynAIRgy, the Second 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":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces FDA Update for Supplemental NDA for HETLIOZ\u00ae in the Treatment of Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase III"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II\/ Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"}]

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            Details:

            McMaster University researchers using MediPharm Labs’ CBD50 formula and CBD:THC 10:2 formulation, which has the same as MediPharm Labs’ CBD25, have received a No Objection Letter from Health Canada to begin recruiting human subjects for a placebo-controlled trial.

            Lead Product(s): Cannabidiol

            Therapeutic Area: Sleep Product Name: CBD50

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: McMaster University

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2021

            Medipharm CB

            TMF Summit 2024

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            Details:

            Three initial proposed clinical trials will evaluate the effectiveness of proprietary THC and CBD (cannabidiol) drug candidates for multiple indications including Pain, Insomnia associated with Major Depression, and Uremic Pruritus.

            Lead Product(s): Cannabidiol,Tetrahydrocannabinol

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: McMaster University

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 21, 2021

            Medipharm CB

            TMF Summit 2024

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            TAK-861 is an oral orexin agonist which is being evaluated in phase 2/3 clinical trials for the treatment of patients with Narcolepsy Type 1 & Type 2.

            Lead Product(s): TAK-861

            Therapeutic Area: Sleep Product Name: TAK-861

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 08, 2024

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            Hetlioz (tasimelteon) is a melatonin receptor agonist. It is being evaluated in Phase 3 clinical trials for the treatment of insomnia characterized by difficulties with sleep initiation.

            Lead Product(s): Tasimelteon

            Therapeutic Area: Sleep Product Name: Hetlioz

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 05, 2024

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            AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep Apnea.

            Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride

            Therapeutic Area: Sleep Product Name: AD109

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 21, 2023

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            Under the agreement, Roche obtains global development, manufacturing, and commercialization rights to RO7117997, an IND-ready ENT1 inhibitor discovered using the PsychoGenics’ AI-enabled phenotypic screening platforms.

            Lead Product(s): RO7117997

            Therapeutic Area: Sleep Product Name: RO7117997

            Highest Development Status: Preclinical Product Type: Undisclosed

            Partner/Sponsor/Collaborator: PsychoGenics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement December 01, 2023

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            Details:

            Under the agreement, NLS may acquire development and commercialization rights to Aexon Labs' dual orexin receptor agonists platform for the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders.

            Lead Product(s): Undisclosed

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Aexon Labs

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement December 01, 2023

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            Details:

            The joint venture will initially focus on accelerating the discovery, preclinical and clinical development of novel pharmacologic solutions designed to address the complex pathology of obstructive sleep apnea.

            Lead Product(s): Undisclosed

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Discovery Product Type: Small molecule

            Partner/Sponsor/Collaborator: Shionogi

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement October 31, 2023

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            Details:

            ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1).

            Lead Product(s): ORX750

            Therapeutic Area: Sleep Product Name: ORX750

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 25, 2023

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            Details:

            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.

            Lead Product(s): Pitolisant Hydrochloride

            Therapeutic Area: Sleep Product Name: Wakix

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2023

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