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III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oral Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Inapplicable"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"H3 receptor","graph1":"Sleep","graph2":"Approved FDF","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oral Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Harmony Biosciences \/ Inapplicable"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"H3 receptor","graph1":"Sleep","graph2":"Approved FDF","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Harmony Biosciences \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Harmony Biosciences \/ Inapplicable"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"H3 receptor","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oral Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Inapplicable"},{"orgOrder":0,"company":"Aytu BioScience","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Controlled Substance","year":"2020","type":"Inapplicable","leadProduct":"Zolpidem Tartrate","moa":"GABA-A receptor-alpha1\/beta1\/gamma2","graph1":"Sleep","graph2":"Approved FDF","graph3":"Aytu BioScience","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oromucosal Spray","sponsorNew":"Aytu BioScience \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Aytu BioScience \/ Inapplicable"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Peptide","year":"2024","type":"Inapplicable","leadProduct":"Tirzepatide","moa":"GLP-1 receptor","graph1":"Sleep","graph2":"Phase III","graph3":"Eli Lilly","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Eli Lilly \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Eli Lilly \/ Inapplicable"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Other Small Molecule","year":"2025","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"H3 receptor","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Harmony Biosciences \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Inapplicable"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Peptide","year":"2024","type":"Inapplicable","leadProduct":"Tirzepatide","moa":"GLP-1 receptor","graph1":"Sleep","graph2":"Approved FDF","graph3":"Eli Lilly","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Eli Lilly \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Eli Lilly \/ Inapplicable"},{"orgOrder":0,"company":"Pharmanovia","sponsor":"Lindus Health","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"UNITED KINGDOM","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Chloral Hydrate","moa":"Undisclosed","graph1":"Sleep","graph2":"Phase IV","graph3":"Pharmanovia","amount2":0,"highestDevelopmentShortName":"Ph IV","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Pharmanovia \/ Lindus Health","highestDevelopmentStatusID":"11","companyTruncated":"Pharmanovia \/ Lindus Health"}]

Find Clinical Drug Pipelines for Sleep

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          Lead Product(s) : Zolpidem Tartrate

                          Therapeutic Area : Sleep

                          Study Phase : Approved FDF

                          Sponsor : Cosette Pharma

                          Deal Size : Undisclosed

                          Deal Type : Acquisition

                          Details : Cosette Pharmaceuticals Acquires Ambien (Zolpidem Tartrate) Tablet from Sanofi US. It is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

                          Product Name : Ambien

                          Product Type : Controlled Substance

                          Upfront Cash : Undisclosed

                          October 07, 2024

                          Lead Product(s) : Zolpidem Tartrate

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Cosette Pharma

                          Deal Size : Undisclosed

                          Deal Type : Acquisition

                          Sanofi Company Banner

                          02

                          Details : Ambien-Generic (zolpidem tartrate) is a small molecule, GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator. It is indicated for the treatment of insomnia.

                          Product Name : Ambien-Generic

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          August 07, 2021

                          Lead Product(s) : Zolpidem Tartrate

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Breckenridge Pharmaceutical

                          03

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details :

                          Product Name : Undisclosed

                          Product Type : Controlled Substance

                          Upfront Cash : $3.0 million

                          March 03, 2025

                          Lead Product(s) : Cannabidiol

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase III

                          Sponsor : Sandoz B2B

                          Deal Size : $19.0 million

                          Deal Type : Licensing Agreement

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                          04

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Under the agreement, Nxera will be responsible for the supply of Quviviq (Daridorexant HCl) & Holling will be responsible for regulatory, commercial activities and will hold all regulatory approvals.

                          Product Name : Quviviq

                          Product Type : Controlled Substance

                          Upfront Cash : Undisclosed

                          February 28, 2025

                          Lead Product(s) : Daridorexant HCl

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Holling Bio-Pharma

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          05

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : AEX-2 is a potential first-in-class non-sulfonamide dual orexin receptor agonist (DOXA), which is being evaluated for narcolepsy and related neurological disorders.

                          Product Name : AEX-2

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          February 27, 2025

                          Lead Product(s) : AEX-2

                          Therapeutic Area : Sleep

                          Highest Development Status : Preclinical

                          Sponsor : Aexon Labs

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of idiopathic hypersomnia.

                          Product Name : Wakix

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          February 19, 2025

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase III

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Acquiring the US rights to PROVIGIL (modafinil) and NUVIGIL (armodafinil) indicated to improve wakefulness in adult patients marks a strategic milestone for Apotex.

                          Product Name : Provigil

                          Product Type : Other Small Molecule

                          Upfront Cash : Undisclosed

                          January 09, 2025

                          Lead Product(s) : Modafinil

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Apotex Inc

                          Deal Size : Undisclosed

                          Deal Type : Acquisition

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                          08

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Neuraxpharm has acquired these products Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of EDS in adults with narcolepsy.

                          Product Name : Provigil

                          Product Type : Other Small Molecule

                          Upfront Cash : Undisclosed

                          January 07, 2025

                          Lead Product(s) : Modafinil

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Neuraxpharm

                          Deal Size : Undisclosed

                          Deal Type : Acquisition

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                          09

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Zepbound (tirzepatide) injection is a first obstructive sleep apnea in adults with obesity treatment of its kind that activates both GIP/GLP-1 hormone receptors.

                          Product Name : Zepbound

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          December 20, 2024

                          Lead Product(s) : Tirzepatide

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          AAN
                          Not Confirmed
                          AAN
                          Not Confirmed

                          Details : Quviviq (daridorexant Hcl) is a OX1R/OX2R inhibitor, small molecule drug candidate, which is currently being evaluated for the treatment of insomnia in adults.

                          Product Name : Quviviq

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          December 18, 2024

                          Lead Product(s) : Daridorexant HCl

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Shionogi

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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