[{"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":"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":"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":"Miromatrix Medical","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":"Miromatrix Medical"},{"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"}]
Find FDA Investigational New Drug (IND) Submissions for Hepatology (Liver, Pancreatic, Gall Bladder)
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.
The miroliverELAP IND application was submitted in mid-November. The FDA indicated they will provide an official clinical hold letter to Miromatrix within 30 days. Miromatrix plans to provide additional updates pending communication with the FDA.
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).
Ventus retains the right to develop NLRP3 inhibitors for certain systemic diseases, including specific inflammatory and respiratory diseases. In addition, Ventus retains worldwide rights to the company’s distinct brain-penetrant NLRP3 inhibitor program, VENT-01.
ECC4703 was discovered from Eccogene's internal drug discovery platform. It is a β-selective, liver targeting THR full agonist. ECC4703 has demonstrated superiority in pre-clinical studies over partial agonist MGL-3196.
Revive Therapeutics is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
ASC42 is an in-house developed，novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
ASC42 is an in-house developed Farnesoid X Receptor (FXR) agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
ASC42 is an in-house developed Farnesoid X Receptor (FXR) agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.
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