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    [{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Ursodeoxycholic Acid","moa":"AKR1C2","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved","graph3":"Strides Pharma Science","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Strides Pharma Science \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Strides Pharma Science \/ Not Applicable"},{"orgOrder":0,"company":"AllianceRx Walgreens Prime","sponsor":"Duquesne University School of Pharmacy","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Obeticholic Acid","moa":"Farnesoid X receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved","graph3":"AllianceRx Walgreens Prime","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"","sponsorNew":"AllianceRx Walgreens Prime \/ Duquesne University School of Pharmacy","highestDevelopmentStatusID":"12","companyTruncated":"AllianceRx Walgreens Prime \/ Duquesne University School of Pharmacy"},{"orgOrder":0,"company":"Intercept Pharmaceuticals","sponsor":"Advanz Pharma","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2022","type":"Acquisition","leadProduct":"Obeticholic Acid","moa":"Farnesoid X receptor","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved","graph3":"Intercept Pharmaceuticals","amount2":0.45000000000000001,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Hepatology","amount2New":0.45000000000000001,"dosageForm":"Tablet","sponsorNew":"Intercept Pharmaceuticals \/ Advanz Pharma","highestDevelopmentStatusID":"12","companyTruncated":"Intercept Pharmaceuticals \/ Advanz Pharma"},{"orgOrder":0,"company":"Intercept Pharmaceuticals","sponsor":"Alfasigma","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2023","type":"Acquisition","leadProduct":"Obeticholic Acid","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved","graph3":"Intercept Pharmaceuticals","amount2":0.79000000000000004,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Hepatology","amount2New":0.79000000000000004,"dosageForm":"Tablet","sponsorNew":"Intercept Pharmaceuticals \/ Alfasigma","highestDevelopmentStatusID":"12","companyTruncated":"Intercept Pharmaceuticals \/ Alfasigma"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Ursodeoxycholic Acid","moa":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved","graph3":"Strides Pharma Science","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Strides Pharma Science \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Strides Pharma Science \/ Not Applicable"},{"orgOrder":0,"company":"Johnson & Johnson","sponsor":"Gilead","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2024","type":"Licensing Agreement","leadProduct":"Seladelpar Lysine","moa":"","graph1":"Technology","graph2":"Phase I\/II","graph3":"Johnson & Johnson","amount2":0.32000000000000001,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Technology","amount2New":0.94999999999999996,"dosageForm":"","sponsorNew":"Johnson & Johnson \/ Gilead","highestDevelopmentStatusID":"14","companyTruncated":"Johnson & Johnson \/ Gilead"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Seladelpar Lysine","moa":"","graph1":null,"graph2":null,"graph3":"Gilead Sciences","amount2":0,"highestDevelopmentShortName":null,"therapeuticAreaShortName":null,"amount2New":0,"dosageForm":"","sponsorNew":"Gilead Sciences \/ Not Applicable","highestDevelopmentStatusID":null,"companyTruncated":"Gilead Sciences \/ Not Applicable"}]

    Find Clinical Drug Pipeline Developments & Deals for Ursodiol

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    Ursodiol

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                            01

                            Strides Pharma Science

                            India
                            CPhI India 2024
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

                            Lead Product(s) : Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Strides Receives USFDA Approval for Ursodiol Capsules

                            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.

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            January 25, 2021

                            Lead Product(s) : Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Strides Pharma Science

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                            02

                            Strides Pharma Science

                            India
                            CPhI India 2024
                            Attending
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

                            Lead Product(s) : Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Strides Receives USFDA Approval for Ursodiol Tablets

                            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 ...

                            Brand Name : Urso Forte-Generic

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 21, 2020

                            Lead Product(s) : Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            Strides Pharma Science

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                            03

                            Gilead Sciences

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed

                            Gilead Sciences

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed
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                            Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            With FDA Approval of Livdelzi, Gilead Launches an Inflammatory Drug for The First Time

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

                            Brand Name : Livdelzi

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 15, 2024

                            Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Johnson & Johnson

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed

                            Johnson & Johnson

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                            euroPLX 86 Munich
                            Not Confirmed
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                            Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Gilead

                            Deal Size : $320.0 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Gilead shells out $320M to J&J to buy out rare liver disease drug royalties

                            Details : Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.

                            Brand Name : Livdelzi

                            Molecule Type : Small molecule

                            Upfront Cash : Undisclosed

                            August 08, 2024

                            Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Gilead

                            Deal Size : $320.0 million

                            Deal Type : Licensing Agreement

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                            05

                            Intercept Pharmaceuticals

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed

                            Intercept Pharmaceuticals

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed
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                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Alfasigma

                            Deal Size : $794.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of...

                            Details : Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate respon...

                            Brand Name : Ocaliva

                            Molecule Type : Small molecule

                            Upfront Cash : $794.0 million

                            September 26, 2023

                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Alfasigma

                            Deal Size : $794.0 million

                            Deal Type : Acquisition

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                            06

                            Intercept Pharmaceuticals

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed

                            Intercept Pharmaceuticals

                            U.S.A arrow
                            euroPLX 86 Munich
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Advanz Pharma

                            Deal Size : $450.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Intercept Announces Advanz Pharma to Acquire Ocaliva in PBC in Markets Outside the U.S. for up to $450MM, incl...

                            Details : Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.

                            Brand Name : Ocaliva

                            Molecule Type : Small molecule

                            Upfront Cash : $405.0 million

                            May 05, 2022

                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Advanz Pharma

                            Deal Size : $450.0 million

                            Deal Type : Acquisition

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                            07

                            AllianceRx Walgreens Prime

                            Country arrow
                            euroPLX 86 Munich
                            Not Confirmed

                            AllianceRx Walgreens Prime

                            Country arrow
                            euroPLX 86 Munich
                            Not Confirmed
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                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Study Phase : Approved

                            Sponsor : Duquesne University School of Pharmacy

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            AllianceRx Walgreens Prime Studies Use of Ocaliva® in the Treatment of Primary Biliary Cholangitis

                            Details : A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.

                            Brand Name : Ocaliva

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            March 30, 2022

                            Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid

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

                            Highest Development Status : Approved

                            Sponsor : Duquesne University School of Pharmacy

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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