[{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Baclofen","moa":"GABA B receptor","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Baclofen","moa":"GABA B receptor","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"FRANCE","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Baclofen","moa":"PMP22 gene overexpression","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Currax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Naltrexone Hydrochloride","moa":"Opioid receptor","graph1":"Psychiatry\/Psychology","graph2":"Phase II","graph3":"Currax","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Extended-release Tablet","sponsorNew":"Currax \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Currax \/ Not Applicable"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Nafamstat Mesylate","moa":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I","graph3":"Ensysce Biosciences","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Ensysce Biosciences \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Ensysce Biosciences \/ Not Applicable"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Naltrexone Hydrochloride","moa":"TLR","graph1":"Infections and Infectious Diseases","graph2":"Phase I","graph3":"Statera Biopharma","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Statera Biopharma \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Statera Biopharma \/ Not Applicable"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Immune Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Agreement","leadProduct":"Naltrexone Hydrochloride","moa":"TLR","graph1":"Infections and Infectious Diseases","graph2":"Phase I","graph3":"Statera Biopharma","amount2":0.40000000000000002,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Infectious Diseases","amount2New":0.40000000000000002,"dosageForm":"Capsule","sponsorNew":"Statera Biopharma \/ Immune Therapeutics","highestDevelopmentStatusID":"6","companyTruncated":"Statera Biopharma \/ Immune Therapeutics"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Naltrexone Hydrochloride","moa":"Opioid receptor","graph1":"Musculoskeletal","graph2":"Phase I","graph3":"Scilex Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Delayed Release Capsule","sponsorNew":"Scilex Pharmaceuticals \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Scilex Pharmaceuticals \/ Not Applicable"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"FRANCE","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Baclofen","moa":"PMP22 gene overexpression","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Baclofen","moa":"PMP22 gene overexpression","graph1":"Musculoskeletal","graph2":"Approved","graph3":"Amneal Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Granule","sponsorNew":"Amneal Pharmaceuticals \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Amneal Pharmaceuticals \/ Not Applicable"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"FRANCE","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Baclofen","moa":"PMP22 gene overexpression","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"FRANCE","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Baclofen","moa":"PMP22 gene overexpression","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Pharnext","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Pharnext \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Pharnext \/ Not Applicable"},{"orgOrder":0,"company":"Halberd Corporation","sponsor":"Hamden Group","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Agreement","leadProduct":"Naltrexone Hydrochloride","moa":"Mu opoid receptor","graph1":"Neurology","graph2":"Undisclosed","graph3":"Halberd Corporation","amount2":0,"highestDevelopmentShortName":"Undisclosed","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Halberd Corporation \/ Hamden Group","highestDevelopmentStatusID":"1","companyTruncated":"Halberd Corporation \/ Hamden Group"},{"orgOrder":0,"company":"Currax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Nutrition and Weight Loss","country":"U.S.A","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Naltrexone Hydrochloride","moa":"","graph1":"Nutrition and Weight Loss","graph2":"Approved","graph3":"Currax","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Nutrition & Weight Loss","amount2New":0,"dosageForm":"Tablet, Extended Release","sponsorNew":"Currax \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Currax \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for Naltrexone Hydrochloride

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                          Top Deals by Deal Size (USD bn)

                          01

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Contrave, also marketed as Mysimba is an extended release fixed dose combination of naltrexone HCL/bupropion HCL indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.

                          Brand Name : Contrave

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 18, 2023

                          Lead Product(s) : Naltrexone Hydrochloride,Bupropion Hydrochloride

                          Therapeutic Area : Nutrition and Weight Loss

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Under this agreement, Hamden will have worldwide exclusive rights to sell, market and distribute the HALB patented low-dose Naltrexone medication, and the HALB proprietary Vita-Shield-Max TM Nutraceutical Product.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          November 14, 2022

                          Lead Product(s) : Naltrexone Hydrochloride

                          Therapeutic Area : Neurology

                          Highest Development Status : Undisclosed

                          Sponsor : Hamden Group

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          03

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.

                          Brand Name : PXT3003

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 13, 2022

                          Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.

                          Brand Name : PXT3003

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 12, 2022

                          Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.

                          Brand Name : Lyvispah

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          June 01, 2022

                          Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total...

                          Brand Name : PXT3003

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          May 16, 2022

                          Lead Product(s) : Baclofen,Naltrexone Hydrochloride,Sorbitol API

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Phase 1 clinical trial data showed that SP-104 (naltrexone hydrochloride) treated healthy volunteers and had lower rates of adverse events, as compared with immediate release naltrexone -treated volunteers.

                          Brand Name : SP-104

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          May 11, 2022

                          Lead Product(s) : Naltrexone Hydrochloride

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : Phase I

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Statera will receive milestones, new indications and royalties, Crohn’s disease and COVID-19 indications and regulatory approvals, payments from Immune Therapeutics in exchange for Statera’s rights to any product containing low-dose naltrexone as an ...

                          Brand Name : STAT-205

                          Molecule Type : Small molecule

                          Upfront Cash : $2.0 million

                          April 27, 2022

                          Lead Product(s) : Naltrexone Hydrochloride

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase I

                          Sponsor : Immune Therapeutics

                          Deal Size : $402.0 million

                          Deal Type : Agreement

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                          09

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : STAT-205 may show promise in treating both acute COVID infections and long COVID in this manner. Preliminary in vitro data demonstrated the drug’s ability to slow or halt the progression of SARS-CoV-2 (the virus that causes COVID-19) in human lung cell...

                          Brand Name : STAT-205

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          March 02, 2022

                          Lead Product(s) : Naltrexone Hydrochloride

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase I

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : The Part A of the trial evaluated three dose levels of PF614 showed positive review from the Phase 1b tria, independent Safety Review Committee allowed the trial to proceed to the next dose level.

                          Brand Name : PRF06104

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          January 04, 2022

                          Lead Product(s) : Oxycodone Prodrug,Nafamostat,Naltrexone Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Phase I

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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