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[{"orgOrder":0,"company":"Enleofen Bio Pte","sponsor":"Boehringer Ingelheim GmbH","pharmaFlowCategory":"D","amount":"$1,000.0 million","upfrontCash":"$1,000.0 million","newsHeadline":"Boehringer Ingelheim Partners with Enleofen to Develop First-in-Class Anti-IL-11 Therapies for a Range of Fibrotic Diseases","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"SINGAPORE","productType":"Large molecule","productStatus":"Undisclosed","date":"January 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Enleofen Bio Pte"},{"orgOrder":0,"company":"Theraly Fibrosis","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","amount":"$5.9 million","upfrontCash":"Undisclosed","newsHeadline":"Theraly Fibrosis Awarded $3.9 Million SBIR Phase II Grant to Support Development of TLY012 for Chronic Pancreatitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Theraly Fibrosis"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascletis\\' IND Filing for Its Non-alcoholic Steatohepatitis (NASH) Drug Accepted by NMPA","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Ascletis Pharma"},{"orgOrder":0,"company":"Lipocine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Lipocine"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascletis' THR- beta Agonist ASC41 Receives Approval for Clinical Trials of NASH Indication","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Ascletis Pharma"},{"orgOrder":0,"company":"Alnylam Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alnylam Submits CTA Application In UK To Start Phase 1 Trial Of ALN-HSD To Treat NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Alnylam Pharmaceuticals"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gannex Filed US IND for Its NASH Drug ASC42, an FXR Agonist","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Ascletis Pharma"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gannex a Wholly Owned Subsidiary of Ascletis Pharma Received US IND Approval for its NASH Drug Candidate ASC42","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Ascletis Pharma"},{"orgOrder":0,"company":"Ascletis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42\uff0can FXR Agonist","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Ascletis Pharma"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Provides Update on Cannabinoid Pharmaceuticals Program","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"orgOrder":0,"company":"Cour Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Cour Pharmaceuticals"},{"orgOrder":0,"company":"Eccogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eccogene Announces US IND Approval for THR\u03b2 Agonist ECC4703","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Eccogene"},{"orgOrder":0,"company":"First Wave BioPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Wave BioPharma Files Investigational New Drug Application for Enhanced Microgranule Delivery Formulation of Adrulipase","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"First Wave BioPharma"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Miromatrix Announces FDA Clinical Hold on IND Application for miroliverELAP","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"United Therapeutics"},{"orgOrder":0,"company":"First Wave BioPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Wave BioPharma Provides Update on IND Filing For Phase 2 Trial of Enhanced Microgranule Formulation of Adrulipase for Exocrine Pancreatic Insufficiency","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"First Wave BioPharma"},{"orgOrder":0,"company":"First Wave BioPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"First Wave BioPharma"},{"orgOrder":0,"company":"First Wave BioPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients with Cystic Fibrosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"First Wave BioPharma"},{"orgOrder":0,"company":"Ventus Therapeutics","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","amount":"$703.0 million","upfrontCash":"$70.0 million","newsHeadline":"Ventus Therapeutics Enters Exclusive Development and License Agreement with Novo Nordisk for NLRP3 Inhibitor Program","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Ventus Therapeutics"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Baxter Healthcare Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Miromatrix and Baxter Announce Collaborative Research Agreement Aiming to Advance Care for Patients with Acute Liver Failure","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"United Therapeutics"},{"orgOrder":0,"company":"United Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Miromatrix Provides Update on miroliverELAP","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"United Therapeutics"},{"orgOrder":0,"company":"ChemomAb","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chemomab Announces FDA Clearance of Investigational New Drug Application for Phase 2 Clinical Trial of CM-101 in Patients with Systemic Sclerosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"ChemomAb"},{"orgOrder":0,"company":"NeuroBo Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NeuroBo Pharmaceuticals Announces Submission of IND Application to the FDA for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"NeuroBo Pharmaceuticals"},{"orgOrder":0,"company":"Galmed Pharmaceuticals","sponsor":"Virginia Commonwealth University","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galmed Announces Initiation of a Clinical Development Program to Evaluate Aramchol meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC)","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Galmed Pharmaceuticals"},{"orgOrder":0,"company":"Hepagene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hepagene Therapeutics Announces FDA Clearance of Investigational New Drug Application (IND) for HPG7233 THR Beta Agonist","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Hepagene Therapeutics"},{"orgOrder":0,"company":"LISCure Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LISCure Biosciences Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"IND Enabling","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"LISCure Biosciences"}]

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

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            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.

            Lead Product(s): LB-P8

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LB-P8

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 29, 2024

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

            Lead Product(s): HPG7233

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HPG7233

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 20, 2023

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            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.

            Lead Product(s): Aramchol Meglumine

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Virginia Commonwealth University

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 09, 2023

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            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.

            Lead Product(s): DA-1241

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: DA-1241

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 03, 2023

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            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 orphan diseases.

            Lead Product(s): CM-101

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CM-101

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 21, 2023

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            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 therapies.

            Lead Product(s): MiroliverELAP

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MiroliverELAP

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Baxter Healthcare Corporation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration February 01, 2023

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            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.

            Lead Product(s): MiroliverELAP

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MiroliverELAP

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2023

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            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).

            Lead Product(s): Adrulipase

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: FW-EPI

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 31, 2023

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            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).

            Lead Product(s): Adrulipase

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: FW-EPI

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 25, 2023

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            FW-EPI (adrulipase) is an oral administered, recombinant lipase enzyme, non-systemic biologic capsule for the treatment of EPI associated with CF and CP. It is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients.

            Lead Product(s): Adrulipase

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: FW-EPI

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 13, 2023

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