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Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Sleep","country":"U.S.A","productType":"Miscellaneous","year":"2022","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Sleep","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Sleep","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Miscellaneous","year":"2020","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Miscellaneous","year":"2023","type":"Inapplicable","leadProduct":"Pitolisant Hydrochloride","moa":"Undisclosed","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Harmony Biosciences \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Undisclosed"},{"orgOrder":0,"company":"Harmony 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Biosciences","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2020","type":"Inapplicable","leadProduct":"Clemizole hydrochloride","moa":"TRPC5","graph1":"Neurology","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Solution","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Harmony Biosciences","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"U.S.A","productType":"Miscellaneous","year":"2021","type":"Inapplicable","leadProduct":"Clemizole hydrochloride","moa":"TRPC5","graph1":"Rare Diseases and Disorders","graph2":"Phase III","graph3":"Harmony Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Solution","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"10","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Epygenix Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"U.S.A","productType":"Miscellaneous","year":"2024","type":"Acquisition","leadProduct":"Clemizole hydrochloride","moa":"TRPC5","graph1":"Neurology","graph2":"Phase II","graph3":"Harmony Biosciences","amount2":0.68000000000000005,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Neurology","amount2New":0.68000000000000005,"dosageForm":"Solution","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"8","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Bioprojet Pharma","pharmaFlowCategory":"D","therapeuticArea":"Sleep","country":"FRANCE","productType":"Miscellaneous","year":"2024","type":"Licensing Agreement","leadProduct":"TPM-1116","moa":"Undisclosed","graph1":"Sleep","graph2":"Preclinical","graph3":"Harmony Biosciences","amount2":0.39000000000000001,"highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Sleep","amount2New":0.39000000000000001,"dosageForm":"Undisclosed","sponsorNew":"Harmony Biosciences \/ Harmony Biosciences","highestDevelopmentStatusID":"4","companyTruncated":"Harmony Biosciences \/ Harmony Biosciences"}]

Find Clinical Drug Pipeline Developments & Deals by Harmony Biosciences

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                          Top Deals by Deal Size (USD bn)

                          01

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : HBS-201 (Pitolisant HCl) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Narcolepsy.

                          Product Name : HBS-201

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          July 04, 2025

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase I

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          02

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : ZYN002 is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

                          Product Name : Undisclosed

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          April 16, 2025

                          Lead Product(s) : Cannabidiol

                          Therapeutic Area : Undisclosed

                          Highest Development Status : Phase I

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated for the treatment of Fragile X Syndrome.

                          Product Name : Undisclosed

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          April 08, 2025

                          Lead Product(s) : Cannabidiol

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          PREP
                          Not Confirmed
                          PREP
                          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 : Miscellaneous

                          Upfront Cash : Inapplicable

                          February 19, 2025

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.

                          Product Name : Wakix

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          June 24, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Sleep

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : The acquisition enhances Harmony's strategy by adding a rare epilepsy franchise, including EPX-100, a potent oral 5HT2 agonist, to its innovative CNS pipeline.

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : $35.0 million

                          April 30, 2024

                          Lead Product(s) : Clemizole hydrochloride

                          Therapeutic Area : Neurology

                          Highest Development Status : Phase II

                          Recipient : Epygenix Therapeutics

                          Deal Size : $680.0 million

                          Deal Type : Acquisition

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                          07

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : Pitolisant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prader-Willi Syndrome.

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          April 16, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : Through the Licensing Agreement, Bioprojet will develop, manufacture, and commercialize TPM-1116, a selective oral orexin-2 receptor agonist for narcolepsy and other sleep/wake disorders.

                          Product Name : Undisclosed

                          Product Type : Miscellaneous

                          Upfront Cash : $25.5 million

                          April 11, 2024

                          Lead Product(s) : TPM-1116

                          Therapeutic Area : Sleep

                          Highest Development Status : Preclinical

                          Recipient : Bioprojet Pharma

                          Deal Size : $393.0 million

                          Deal Type : Licensing Agreement

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                          09

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

                          Product Name : Wakix

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          April 03, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          PREP
                          Not Confirmed
                          PREP
                          Not Confirmed

                          Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

                          Product Name : Wakix

                          Product Type : Miscellaneous

                          Upfront Cash : Inapplicable

                          February 20, 2024

                          Lead Product(s) : Pitolisant Hydrochloride

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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