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Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Madrigal Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Madrigal Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Madrigal Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Resmetirom","moa":"TR-beta","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Madrigal Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Madrigal Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Madrigal Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Madrigal Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2021","type":"Inapplicable","leadProduct":"Resmetirom","moa":"TR-beta","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Madrigal Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Madrigal Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Madrigal Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"CANbridge Pharmaceuticals","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ CANbridge Pharmaceuticals","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ CANbridge Pharmaceuticals"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum 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Inapplicable"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Abacus Medicine","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Agreement","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ Abacus Medicine","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ Abacus Medicine"},{"orgOrder":0,"company":"Mirum Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Maralixibat Chloride","moa":"IBAT","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Mirum Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Solution","sponsorNew":"Mirum Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Mirum Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Jazz Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"IRELAND","productType":"Peptide","year":"2020","type":"Inapplicable","leadProduct":"Defibrotide Sodium","moa":"Plasminogen","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Jazz Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Injection","sponsorNew":"Jazz Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Jazz Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"INDIA","productType":"Other Small Molecule","year":"2021","type":"Inapplicable","leadProduct":"Ursodeoxycholic Acid","moa":"AKR1C2","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Strides Pharma Science","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"Strides Pharma Science \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Strides Pharma Science \/ Inapplicable"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall 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Biopharma","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Sunshine Biopharma \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Sunshine Biopharma \/ Inapplicable"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"INDIA","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Saroglitazar magnesium","moa":"PPA-alpha\/gamma receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Zydus Lifesciences","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Zydus Lifesciences \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Zydus Lifesciences \/ Inapplicable"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"INDIA","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Saroglitazar magnesium","moa":"PPA-alpha\/gamma receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Zydus Lifesciences","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Zydus Lifesciences \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Zydus Lifesciences \/ Inapplicable"},{"orgOrder":0,"company":"Koligo Therapeutics","sponsor":"Orgenesis","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Cell and Gene therapy","year":"2020","type":"Acquisition","leadProduct":"Autologous Pancreatic Islets Cell","moa":"Undisclosed","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Koligo Therapeutics","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Koligo Therapeutics \/ Orgenesis","highestDevelopmentStatusID":"15","companyTruncated":"Koligo Therapeutics \/ Orgenesis"},{"orgOrder":0,"company":"Genfit","sponsor":"Ipsen","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"FRANCE","productType":"Other Small Molecule","year":"2025","type":"Licensing Agreement","leadProduct":"Elafibranor","moa":"||PPA receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved FDF","graph3":"Genfit","amount2":0.54000000000000004,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Hepatology","amount2New":0.54000000000000004,"dosageForm":"Oral Tablet, Film Coated","sponsorNew":"Genfit \/ Ipsen","highestDevelopmentStatusID":"15","companyTruncated":"Genfit \/ Ipsen"}]

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          Lead Product(s) : Ursodeoxycholic Acid

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

                          Study Phase : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Details : Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.

                          Product Name : Urso Forte-Generic

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          January 25, 2021

                          Lead Product(s) : Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Strides Pharma Science

                          02

                          Lead Product(s) : Ursodeoxycholic Acid

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

                          Study Phase : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Details : USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary ...

                          Product Name : Urso Forte-Generic

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          August 21, 2020

                          Lead Product(s) : Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

                          Strides Pharma Science

                          03

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Under the licensing agreement, Ipsen’s Iqirvo (elafibranor) has been granted pricing and reimbursement in Italy for Primary Biliary Cholangitis.

                          Product Name : Iqirvo

                          Product Type : Other Small Molecule

                          Upfront Cash : $135.7 million

                          May 20, 2025

                          Lead Product(s) : Elafibranor,Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Ipsen

                          Deal Size : $542.8 million

                          Deal Type : Licensing Agreement

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                          04

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).

                          Product Name : Livdelzi

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          February 20, 2025

                          Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).

                          Product Name : Livdelzi

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          December 13, 2024

                          Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, which is indicated for female individuals with primary biliary cholangitis.

                          Product Name : Ocaliva

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          December 11, 2024

                          Lead Product(s) : Obeticholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, which is indicated for the treatment of individuals with primary biliary cholangitis.

                          Product Name : Ocaliva

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          December 02, 2024

                          Lead Product(s) : Obeticholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Ursodiol is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol and the secretion of cholesterol.

                          Product Name : Urso DS-Generic

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          November 22, 2024

                          Lead Product(s) : Ursodeoxycholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, indicated for the treatment of individuals with primary biliary cholangitis.

                          Product Name : Ocaliva

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          October 17, 2024

                          Lead Product(s) : Obeticholic Acid

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          IMCAS Asia
                          Not Confirmed
                          IMCAS Asia
                          Not Confirmed

                          Details : Iqirvo (elafibranor) is an approved, novel, oral, PPAR alpha/delta agonist, as a treatment for patients with primary biliary cholangitis.

                          Product Name : Iqirvo

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          October 10, 2024

                          Lead Product(s) : Elafibranor

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

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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