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[{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Fast Track Status to Calliditas\u2019 Setanaxib for PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"}]

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            Details:

            The TRANSFORM Phase 2b/3 trial for GKT831 (setanaxib), a NOX1 and NOX4 inhibitor, will investigate the effect of setanaxib versus placebo on alkaline phosphatase reduction in patients with PBC also has shown evidence of anti-fibrotic activity in a Phase II clinical trial.

            Lead Product(s): Setanaxib

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 15, 2022

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            Details:

            Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC.

            Lead Product(s): Setanaxib

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT137831

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 09, 2021

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            Details:

            In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue.

            Lead Product(s): Setanaxib

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 09, 2021

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