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    [{"orgOrder":0,"company":"Genkyotex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I","graph3":"Genkyotex","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Respiratory Diseases","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Genkyotex \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Genkyotex \/ Not Applicable"},{"orgOrder":0,"company":"Genkyotex","sponsor":"Genkyotex","pharmaFlowCategory":"D","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2020","type":"Acquisition","leadProduct":"Setanaxib","moa":"NOX4","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase 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Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"9","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","graph1":"Hepatology (Liver, Pancreatic, Gall 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Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Oncology","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Oncology","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","graph1":"Technology","graph2":"Phase I\/II","graph3":"Calliditas Therapeutics AB","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Technology","amount2New":0.94999999999999996,"dosageForm":"","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"14","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"}]

    Find Clinical Drug Pipeline Developments & Deals for Setanaxib

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                            01

                            Calliditas Therapeutics AB

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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

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

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Calliditas Announces Positive TRANSFORM Phase 2b Data in Primary Biliary Cholangitis

                            Details : GKT 831 (setanaxib) is a first‐in‐class selective NOX 1/4 inhibitor. It is being evaluated for the treatment of patients with primary biliary cholangitis

                            Brand Name : GKT 831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            July 26, 2024

                            Lead Product(s) : Setanaxib

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

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Calliditas Therapeutics AB

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                            Medlab Asia & Asia Health
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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Calliditas Reports Positive Phase 2 Results for Head and Neck Cancer Trial with Setanaxib

                            Details : GKT 831 (setanaxib) is a first‐in‐class selective NOX 1/4 inhibitor. It is being evaluated for the treatment of patients with squamous cell carcinoma of the head and neck.

                            Brand Name : GKT 831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            May 06, 2024

                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Calliditas Initiates Clinical Study to Evaluate Setanaxib in Alport Syndrome

                            Details : GKT137831 (setanaxib) is a small molecule oral inhibitor which works by targeting NOX 1/NOX 4, it is currently being investigated for the treatment of Alport syndrome.

                            Brand Name : GKT137831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 30, 2023

                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Calliditas Therapeutics AB

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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Study Phase : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            European Medicines Agency Committee for Orphan Medicinal Products Provides Positive Opinion On Calliditas' App...

                            Details : GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated for the treatment of Alport syndrome and orphan drug designation by the FDA.

                            Brand Name : GKT137831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 05, 2023

                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Calliditas Therapeutics AB

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                            Medlab Asia & Asia Health
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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Study Phase : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for the Treatment of Alport Syndrome with S...

                            Details : GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated for the treatment of Alport syndrome and orphan drug designation by the FDA.

                            Brand Name : GKT137831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 27, 2023

                            Lead Product(s) : Setanaxib

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Calliditas Therapeutics AB

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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Calliditas Announces Supportive Interim Data From Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor C...

                            Details : GKT137831 (setanaxib), an oral tablet, is a NOX 1 and 4 inhibitor, which is being investigated in Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN).

                            Brand Name : GKT137831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            July 13, 2023

                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Calliditas Therapeutics AB

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                            Medlab Asia & Asia Health
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                            Calliditas Therapeutics AB

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                            Medlab Asia & Asia Health
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                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            First Patient Randomized in Phase 2 Trial in Head and Neck Cancer

                            Details : GKT831(setanaxib), a NOX1 and NOX4 inhibitor, has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, an orphan liver disease).

                            Brand Name : GKT831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            May 17, 2022

                            Lead Product(s) : Setanaxib,Pembrolizumab

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Calliditas Therapeutics AB

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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

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

                            Study Phase : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib

                            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 ...

                            Brand Name : GKT831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 15, 2022

                            Lead Product(s) : Setanaxib

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

                            Highest Development Status : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Calliditas Therapeutics AB

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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

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

                            Study Phase : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC

                            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.

                            Brand Name : GKT137831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 09, 2021

                            Lead Product(s) : Setanaxib

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

                            Highest Development Status : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            10

                            Calliditas Therapeutics AB

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                            Medlab Asia & Asia Health
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                            Calliditas Therapeutics AB

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                            Lead Product(s) : Setanaxib

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

                            Study Phase : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            US FDA Grants Fast Track Status to Calliditas’ Setanaxib for PBC

                            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.

                            Brand Name : GKT831

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 09, 2021

                            Lead Product(s) : Setanaxib

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

                            Highest Development Status : Phase II/ Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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