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Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Galmed Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Galmed Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Shilpa Medicare","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"INDIA","productType":"Other Small Molecule","year":"2025","type":"Inapplicable","leadProduct":"Norursodeoxycholic Acid","moa":"Cholesterol","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase III","graph3":"Shilpa Medicare","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Shilpa Medicare \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Shilpa Medicare \/ Inapplicable"}]

    Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase III Clinical Development

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                            Shilpa Medicare

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                            Lead Product(s) : Norursodeoxycholic Acid

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Shilpa Medicare receives CDSCO SEC Nod for IND Nor UDCA tablets for NAFLD treatment

                            Details : SMLNUD07 (norursodeoxycholic acid) tablets 500 mg is recommended marketing authorization for treating non-alcoholic fatty liver disease (nafld) by CDSCO.

                            Product Name : SMLNUD07

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            April 16, 2025

                            Lead Product(s) : Norursodeoxycholic Acid

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            02

                            Galmed Pharmaceuticals

                            Israel arrow
                            AACR Annual meeting
                            Not Confirmed

                            Galmed Pharmaceuticals

                            Israel arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Aramchol meglumine

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Galmed Announces Positive Part 1 Results from the AM-001 Study of Aramchol Meglumine

                            Details : Aramchol meglumine is a first-in-class, novel synthetic small molecule, a conjugate of cholic acid and arachidic acid, liver targeted SCD1 modulator which is being developed for the treatment of NASH.

                            Product Name : Undisclosed

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            April 10, 2025

                            Lead Product(s) : Aramchol meglumine

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

                            Inventiva Pharma

                            France arrow
                            AACR Annual meeting
                            Not Confirmed

                            Inventiva Pharma

                            France arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Lanifibranor

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Inventiva Completes Enrollment in Phase 3 NATiV3 Trial for MASH

                            Details : IVA-337 (lanifibranor) is a pan-peroxisome proliferator–activated receptor agonist, which is being evaluated for the treatment of Nonalcoholic Steatohepatitis.

                            Product Name : IVA337

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            April 01, 2025

                            Lead Product(s) : Lanifibranor

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Shilpa Medicare

                            India arrow
                            AACR Annual meeting
                            Not Confirmed

                            Shilpa Medicare

                            India arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Norursodeoxycholic Acid

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Shilpa Medicare Wins SEC-CDSCO Nod for Nor-Ursodeoxycholic Acid in NASH Market

                            Details : SMLNUD07 (nor ursodeoxycholic acid) tablets 500 mg is recommended marketing authorization for treating non-alcoholic fatty liver disease (nafld) by CDSCO.

                            Product Name : SMLNUD07

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            March 11, 2025

                            Lead Product(s) : Norursodeoxycholic Acid

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Madrigal Pharmaceuticals

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed

                            Madrigal Pharmaceuticals

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed
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                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Resmetirom

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Madrigal Reports Two-Year Data Showing Rezdiffra Benefit in MASH Cirrhosis

                            Details : Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.

                            Product Name : Rezdiffra

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            February 26, 2025

                            Lead Product(s) : Resmetirom

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Inventiva Pharma

                            France arrow
                            AACR Annual meeting
                            Not Confirmed

                            Inventiva Pharma

                            France arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
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                            Lead Product(s) : Lanifibranor

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

                            Study Phase : Phase III

                            Sponsor : Hepalys Pharma

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Inventiva, Hepalys Launch Phase 1 Trial for Lanifibranor in Japan

                            Details : IVA-337 (lanifibranor) is a pan-peroxisome proliferator–activated receptor agonist, which is being evaluated for the treatment of Nonalcoholic Steatohepatitis.

                            Product Name : IVA337

                            Product Type : Other Small Molecule

                            Upfront Cash : Inapplicable

                            February 20, 2025

                            Lead Product(s) : Lanifibranor

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

                            Highest Development Status : Phase III

                            Sponsor : Hepalys Pharma

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            89bio

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed

                            89bio

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Pegozafermin

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

                            Study Phase : Phase III

                            Sponsor : Goldman Sachs & Co

                            Deal Size : $287.5 million

                            Deal Type : Public Offering

                            DEALS_DEV arrow-down

                            89bio Closes Public Offering, Underwriters’ Option Fully Exercised

                            Details : 89bio intends to use the net proceeds to fund clinical development of BIO89-100 (pegozafermin) for the treatment of metabolic dysfunction-associated steatohepatitis and severe hypertriglyceridemia.

                            Product Name : BIO89-100

                            Product Type : Protein

                            Upfront Cash : Undisclosed

                            February 03, 2025

                            Lead Product(s) : Pegozafermin

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

                            Highest Development Status : Phase III

                            Sponsor : Goldman Sachs & Co

                            Deal Size : $287.5 million

                            Deal Type : Public Offering

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                            08

                            Akero Therapeutics

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed

                            Akero Therapeutics

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed
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                            • EDQM
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                            Lead Product(s) : Efruxifermin

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

                            Study Phase : Phase III

                            Sponsor : J.P. Morgan

                            Deal Size : $402.0 million

                            Deal Type : Public Offering

                            DEALS_DEV arrow-down

                            Akero Therapeutics Announces Closing of Upsized Public Offering of Common Stock

                            Details : The net proceeds will be used to advance the clinical development of lead product EFX (efruxifermin). It is being evaluated for the treatment of compensated cirrhosis due to MASH.

                            Product Name : EFX

                            Product Type : Protein

                            Upfront Cash : Undisclosed

                            January 30, 2025

                            Lead Product(s) : Efruxifermin

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

                            Highest Development Status : Phase III

                            Sponsor : J.P. Morgan

                            Deal Size : $402.0 million

                            Deal Type : Public Offering

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                            09

                            Akero Therapeutics

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed

                            Akero Therapeutics

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed
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                            • EDQM
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                            Lead Product(s) : Efruxifermin

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

                            Study Phase : Phase III

                            Sponsor : J.P. Morgan

                            Deal Size : $350.0 million

                            Deal Type : Public Offering

                            DEALS_DEV arrow-down

                            Akero Therapeutics Announces Pricing of Upsized Public Offering of Common Stock

                            Details : The net proceeds will be to advance the clinical development of lead product EFX (efruxifermin). It is being evaluated for the treatment of compensated cirrhosis due to MASH.

                            Product Name : EFX

                            Product Type : Protein

                            Upfront Cash : Undisclosed

                            January 28, 2025

                            Lead Product(s) : Efruxifermin

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

                            Highest Development Status : Phase III

                            Sponsor : J.P. Morgan

                            Deal Size : $350.0 million

                            Deal Type : Public Offering

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                            10

                            89bio

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed

                            89bio

                            U.S.A arrow
                            AACR Annual meeting
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Pegozafermin

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

                            Study Phase : Phase III

                            Sponsor : Goldman Sachs & Co

                            Deal Size : $250.0 million

                            Deal Type : Public Offering

                            DEALS_DEV arrow-down

                            89bio, Inc. Announces Pricing of $250.0 Million Public Offering of Common Stock

                            Details : 89bio intends to use the net proceeds to fund clinical development of BIO89-100 (pegozafermin) for the treatment of metabolic dysfunction-associated steatohepatitis and severe hypertriglyceridemia.

                            Product Name : BIO89-100

                            Product Type : Protein

                            Upfront Cash : Undisclosed

                            January 28, 2025

                            Lead Product(s) : Pegozafermin

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

                            Highest Development Status : Phase III

                            Sponsor : Goldman Sachs & Co

                            Deal Size : $250.0 million

                            Deal Type : Public Offering

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