[{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Baclofen","moa":"||GABA-B receptor","graph1":"Musculoskeletal","graph2":"Approved FDF","graph3":"Amneal Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Oral Granule","sponsorNew":"Amneal Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Amneal Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Currax","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Nutrition and Weight Loss","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Naltrexone Hydrochloride","moa":"||Kappa\/Mu\/delta-Opioid receptor","graph1":"Nutrition and Weight Loss","graph2":"Approved FDF","graph3":"Currax","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Nutrition & Weight Loss","amount2New":0,"dosageForm":"Oral Tablet, Extended Release","sponsorNew":"Currax \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Currax \/ Inapplicable"},{"orgOrder":0,"company":"Currax","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Other Small Molecule","year":"2021","type":"Inapplicable","leadProduct":"Naltrexone Hydrochloride","moa":"||Kappa\/Mu\/delta-Opioid receptor","graph1":"Psychiatry\/Psychology","graph2":"Phase II","graph3":"Currax","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral Tablet, Extended Release","sponsorNew":"Currax \/ Inapplicable","highestDevelopmentStatusID":"8","companyTruncated":"Currax \/ Inapplicable"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2021","type":"Inapplicable","leadProduct":"Naltrexone Hydrochloride","moa":"Kappa\/Mu\/delta-Opioid receptor","graph1":"Infections and Infectious Diseases","graph2":"Phase I","graph3":"Statera Biopharma","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Statera Biopharma \/ Inapplicable","highestDevelopmentStatusID":"6","companyTruncated":"Statera Biopharma \/ Inapplicable"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Immune Therapeutics","pharmaFlowCategory":"D","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Agreement","leadProduct":"Naltrexone Hydrochloride","moa":"Kappa\/Mu\/delta-Opioid receptor","graph1":"Infections and Infectious Diseases","graph2":"Phase I","graph3":"Statera Biopharma","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Statera Biopharma \/ Immune Therapeutics","highestDevelopmentStatusID":"6","companyTruncated":"Statera Biopharma \/ Immune Therapeutics"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Naltrexone Hydrochloride","moa":"Kappa\/Mu\/delta-Opioid receptor","graph1":"Infections and Infectious Diseases","graph2":"Phase I","graph3":"Statera Biopharma","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Statera Biopharma \/ Inapplicable","highestDevelopmentStatusID":"6","companyTruncated":"Statera Biopharma \/ Inapplicable"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Naltrexone Hydrochloride","moa":"Kappa\/Mu\/delta-Opioid receptor","graph1":"Musculoskeletal","graph2":"Phase I","graph3":"Scilex Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Oral Capsule, Delayed Release","sponsorNew":"Scilex Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"6","companyTruncated":"Scilex Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Halberd Corporation","sponsor":"Hamden Group","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Agreement","leadProduct":"Naltrexone Hydrochloride","moa":"Kappa\/Mu\/delta-Opioid receptor","graph1":"Neurology","graph2":"Undisclosed","graph3":"Halberd Corporation","amount2":0,"highestDevelopmentShortName":"Undisclosed","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Halberd Corporation \/ Hamden Group","highestDevelopmentStatusID":"1","companyTruncated":"Halberd Corporation \/ Hamden Group"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2022","type":"Inapplicable","leadProduct":"Nafamstat Mesylate","moa":"||Mu opioid receptor","graph1":"Psychiatry\/Psychology","graph2":"Phase I","graph3":"Ensysce Biosciences","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Ensysce Biosciences \/ Inapplicable","highestDevelopmentStatusID":"6","companyTruncated":"Ensysce Biosciences \/ Inapplicable"}]

Find Clinical Drug Pipeline Developments & Deals for Naltrexone HCl

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01

AAN
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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.

Product Name : Contrave

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 18, 2023

Lead Product(s) : Naltrexone Hydrochloride,Bupropion Hydrochloride

Therapeutic Area : Nutrition and Weight Loss

Highest Development Status : Approved FDF

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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02

AAN
Not Confirmed
AAN
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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.

Product Name : Undisclosed

Product Type : Other 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

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Not Confirmed
AAN
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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.

Product Name : SP-104

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 05, 2022

Lead Product(s) : Naltrexone Hydrochloride

Therapeutic Area : Musculoskeletal

Highest Development Status : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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04

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Not Confirmed
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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 ...

Product Name : STAT-205

Product Type : Other 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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05

AAN
Not Confirmed
AAN
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.

Product Name : PF614

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 01, 2022

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

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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06

AAN
Not Confirmed
AAN
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...

Product Name : STAT-205

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 03, 2022

Lead Product(s) : Naltrexone Hydrochloride

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase I

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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07

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Not Confirmed
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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.

Product Name : Lyvispah

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 06, 2022

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

Therapeutic Area : Musculoskeletal

Highest Development Status : Approved FDF

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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08

AAN
Not Confirmed
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Not Confirmed

Details : CX-101 is an investigational drug that is being studied for smoking cessation.The Phase 3 program builds on the successful Phase 2b findings and evaluates a mixed-weight population at a fixed-dose combination of CX-101 (naltrexone/bupropion 32 mg/360 mg ...

Product Name : Contrave

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 21, 2021

Lead Product(s) : Naltrexone Hydrochloride,Bupropion Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Phase II

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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09

AAN
Not Confirmed
AAN
Not Confirmed

Details : During preclinical in vitro studies, STAT-205 demonstrated an ability to inhibit the replication of coronaviruses in human lung cells. Data also shows that STAT-205 could prevent life-threatening lung inflammation caused by COVID-19, as well as lessen th...

Product Name : STAT-205

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 19, 2021

Lead Product(s) : Naltrexone Hydrochloride

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : IND Enabling

Sponsor : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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