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Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Madrigal Pharmaceuticals"},{"company":"CymaBay Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CymaBay Completes Enrollment for the RESPONSE Global Phase 3 Study Evaluating Seladelpar for Patients with Primary Biliary Cholangitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"CymaBay Therapeutics"},{"company":"Inventiva Pharma","sponsor":"Sino Biopharm","pharmaFlowCategory":"D","amount":"$307.0 million","upfrontCash":"$12.0 million","newsHeadline":"Inventiva and Sino Biopharm Announce Licensing and Collaboration Agreement to Develop and Commercialize Lanifibranor in Greater China","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Inventiva Pharma"}]
Details:
Lanifibranor (IVA337), is an orally-available small molecule with breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) following a positive Phase IIb trial in patients with non-alcoholic steatohepatitis (NASH).
Lead Product(s):
Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: IVA337
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Sino Biopharm
Deal Size: $307.0 million
Upfront Cash: $12.0 million
Deal Type: Licensing Agreement
September 21, 2022
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s):
Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: MBX-8025
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 01, 2022
Details:
Late-breaking data from double-blind portion of noninvasive Phase 3 MAESTRO NAFLD-1 study show MGL-3196 (resmetirom) to be safe and well-tolerated and to reduce liver fat, fibrosis measures on FibroScan and MRE, and liver enzymes, as well as multiple atherogenic lipids.
Lead Product(s):
Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: MGL-3196
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 25, 2022
Details:
MBX-8025 (Seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s):
Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: MBX-8025
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 08, 2022
Details:
Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity.
Lead Product(s):
Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: MGL-3196
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 08, 2022
Details:
OCALIVA (Obeticholic Acid), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
Lead Product(s):
Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: Ocaliva
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 06, 2022
Details:
In addition, improvement of glycemic control in patients who received lanifibranor (IVA337) correlated with the improvement of metabolic-immune markers of NASH insulin resistance, lipid metabolism, inflammation, liver enzymes and with hepatic steatosis.
Lead Product(s):
Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: IVA337
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 03, 2022
Details:
Data were presented demonstrating that MBX-8025 (seladelpar) treatment throughout 2 years resulted in a decrease in PBC GLOBE score and predicted improved transplant-free survival.
Lead Product(s):
Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: MBX-8025
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 23, 2022
Details:
Recent data reinforce the anti-fibrotic activity of Aramchol (arachidyl amido cholanoic acid) previously observed in a wide range of pre-clinical models, in addition to the known effects in liver fibrosis.
Lead Product(s):
Aramchol
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: Aramchol
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 17, 2022
Details:
The Company plans to use the facility toward its preclinical and clinical pipeline, including to help fund a portion of its Phase III clinical trial of IVA337 (lanifibranor), in patients with NASH.
Lead Product(s):
Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)
Product Name: IVA337
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
European Investment Bank
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Financing
May 16, 2022
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