[{"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 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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 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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":"Miromatrix Medical","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":"Miromatrix Medical"},{"orgOrder":0,"company":"Miromatrix Medical","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":"Miromatrix Medical"},{"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"}]
Find FDA Investigational New Drug (IND) Submissions for Hepatology (Liver, Pancreatic, Gall Bladder)
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.
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.
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.
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.
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.
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).
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).
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.
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