[{"orgOrder":0,"company":"Genkyotex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genkyotex Receives Approval From the French Medicines Agency (ANSM) to Initiate a Phase 1 Clinical Study With High-dose Setanaxib","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","year":"2020","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I","graph3":"Genkyotex","amount2":0,"therapeuticAreaNew":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatusNew":"Phase I","highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Respiratory Diseases","productSubType":"","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Genkyotex \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Genkyotex \/ Not Applicable"},{"orgOrder":0,"company":"Genkyotex","sponsor":"Genkyotex","pharmaFlowCategory":"D","amount":"$37.7 million","upfrontCash":"Undisclosed","newsHeadline":"Calliditas Announces Agreement to Acquire Controlling Interest in Genkyotex SA","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","year":"2020","type":"Acquisition","leadProduct":"Setanaxib","moa":"NOX4","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II","graph3":"Genkyotex","amount2":0.040000000000000001,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","amount2New":0.040000000000000001,"dosageForm":"Oral","sponsorNew":"Genkyotex \/ Calliditas","highestDevelopmentStatusID":"8","companyTruncated":"Genkyotex \/ Calliditas"},{"orgOrder":0,"company":"Genkyotex","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genkyotex SA, a subsidiary of Calliditas Therapeutics Announced Positive Phase 1 Results in High-Dose Setanaxib Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","year":"2021","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II","graph3":"Genkyotex","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Genkyotex \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Genkyotex \/ Not Applicable"},{"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":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","year":"2021","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II\/ Phase III","highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","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","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":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","year":"2021","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II\/ Phase III","highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","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","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":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","year":"2022","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II\/ Phase III","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II\/ Phase III","highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Phase 2 Trial in Head and Neck Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","year":"2022","type":"Not Applicable","leadProduct":"Setanaxib","moa":"NOX1","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Announces Supportive Interim Data From Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for the Treatment of Alport Syndrome with Setanaxib","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Genetic Disease","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","productSubType":"","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Committee for Orphan Medicinal Products Provides Positive Opinion On Calliditas' Application for Setanaxib in Alport Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Genetic Disease","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","productSubType":"","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Initiates Clinical Study to Evaluate Setanaxib in Alport Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","year":"2023","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Genetic Disease","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Genetic Disease","productSubType":"Small molecule","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Announces Positive Topline Results of Phase 2 Head and Neck Cancer Trial with Lead NOX Inhibitor Candidate, Setanaxib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","year":"2024","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","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","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Announces Positive TRANSFORM Phase 2b Data in Primary Biliary Cholangitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2024","year":"2024","type":"Not Applicable","leadProduct":"Setanaxib","moa":"","url1":"","url2":"","graph1":"Technology","graph2":"","graph3":"Calliditas Therapeutics AB","amount2":0,"therapeuticAreaNew":"Technology","highestDevelopmentStatusNew":"","highestDevelopmentShortName":"","therapeuticAreaShortName":"Technology","productSubType":"","amount2New":0.94999999999999996,"dosageForm":"","sponsorNew":"Calliditas Therapeutics AB \/ Not Applicable","highestDevelopmentStatusID":"13","companyTruncated":"Calliditas Therapeutics AB \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for Setanaxib

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                          01

                          Luxepack
                          Not Confirmed
                          Luxepack
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                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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

                          Luxepack
                          Not Confirmed
                          Luxepack
                          Not Confirmed

                          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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