[{"orgOrder":0,"company":"Enleofen Bio Pte","sponsor":"Boehringer Ingelheim GmbH","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"SINGAPORE","productType":"Large molecule","year":"2020","type":"Partnership","leadProduct":"Enx108A","moa":"IL-11","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Enleofen Bio Pte","amount2":1,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":1,"dosageForm":"","sponsorNew":"Enleofen Bio Pte \/ Boehringer Ingelheim","highestDevelopmentStatusID":"5","companyTruncated":"Enleofen Bio Pte \/ Boehringer Ingelheim"},{"orgOrder":0,"company":"Theraly Fibrosis","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Large molecule","year":"2020","type":"Funding","leadProduct":"TLY012","moa":"DR5","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Theraly Fibrosis","amount2":0.01,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0.01,"dosageForm":"","sponsorNew":"Theraly Fibrosis \/ National Institutes of Health","highestDevelopmentStatusID":"5","companyTruncated":"Theraly Fibrosis \/ National Institutes of Health"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"CHINA","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"ASC40","moa":"TR-Beta","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Ascletis Pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Ascletis Pharma \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Ascletis Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"ASC42","moa":"Farnesoid X receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Ascletis Pharma","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"Ascletis Pharma \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Ascletis Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Bucillamine","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Revive Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"Revive Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Revive Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Eccogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"ECC4703","moa":"THR beta","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Eccogene","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"Eccogene \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Eccogene \/ Not Applicable"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"miroliverELAP","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"United Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"United Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"United Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Ventus Therapeutics","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Licensing Agreement","leadProduct":"VENT-01","moa":"NLRP3","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Ventus Therapeutics","amount2":0.69999999999999996,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0.69999999999999996,"dosageForm":"","sponsorNew":"Ventus Therapeutics \/ Novo Nordisk","highestDevelopmentStatusID":"5","companyTruncated":"Ventus Therapeutics \/ Novo Nordisk"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Baxter Healthcare Corporation","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Cell and Gene therapy","year":"2023","type":"Collaboration","leadProduct":"MiroliverELAP","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"United Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"United Therapeutics \/ Baxter International","highestDevelopmentStatusID":"5","companyTruncated":"United Therapeutics \/ Baxter International"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Cell and Gene therapy","year":"2023","type":"Not Applicable","leadProduct":"MiroliverELAP","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"United Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"United Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"United Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Hepagene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"HPG7233","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"IND Enabling","graph3":"Hepagene Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"Hepagene Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"5","companyTruncated":"Hepagene Therapeutics \/ Not Applicable"}]

Find FDA Investigational New Drug (IND) Submissions for Hepatology (Liver, Pancreatic, Gall Bladder)

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                          01

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : RTX001 is an engineered autologous macrophage cell therapy designed to deliver anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease like decompensated liver cirrhosis.

                          Brand Name : RTX001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          June 27, 2024

                          Lead Product(s) : RTX001

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : LB-P8 is an investigational live biotherapeutic product consisting of a single bacterial strain (Leuconostoc citreum). It is being evaluated for the treatment of primary sclerosing cholangitis.

                          Brand Name : LB-P8

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          February 29, 2024

                          Lead Product(s) : LB-P8

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : HPG7233, an agonist of thyroid hormone receptor beta (THR-β) for the treatment of patients with non-alcoholic steatohepatitis (NASH) and dyslipidemia.

                          Brand Name : HPG7233

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 20, 2023

                          Lead Product(s) : HPG7233

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : Aramchol meglumine is a first-in-class, novel synthetic small molecule, a conjugate of cholic acid and arachidic acid, liver targeted SCD1 modulato which is being developed for the treatment of primary sclerosing cholangitis.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          May 09, 2023

                          Lead Product(s) : Aramchol Meglumine

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Virginia Commonwealth University

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both NASH and T2D.

                          Brand Name : DA-1241

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 03, 2023

                          Lead Product(s) : DA-1241

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : CM-101 is a monoclonal antibody designed to bind and block CCL24 activity. CM-101 has potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases and is currently undergoing clinical development with primary focus for the o...

                          Brand Name : CM-101

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 21, 2023

                          Lead Product(s) : CM-101

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : As part of the collaboration, Miromatrix has created a new liver therapy called miroliverELAP that combines a Miromatrix single-use bioengineered liver with Baxter’s PrisMax system for patients with acute liver failure (ALF) in need of organ support th...

                          Brand Name : MiroliverELAP

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Undisclosed

                          February 01, 2023

                          Lead Product(s) : MiroliverELAP

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Baxter Healthcare Corporation

                          Deal Size : Undisclosed

                          Deal Type : Collaboration

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                          08

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : MiroliverELAP is a single-use bioengineered liver which is designed to provide therapeutic support to ALF patients in hopes their native livers will regenerate themselves back to health.

                          Brand Name : MiroliverELAP

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          February 01, 2023

                          Lead Product(s) : MiroliverELAP

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : FW-EPI (adrulipase) is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).

                          Brand Name : FW-EPI

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          January 31, 2023

                          Lead Product(s) : Adrulipase

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          Details : FW-EPI (adrulipase) is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP).

                          Brand Name : FW-EPI

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          January 25, 2023

                          Lead Product(s) : Adrulipase

                          Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                          Highest Development Status : IND Enabling

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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