Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 26, 2024
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 05, 2024
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 30, 2023
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 27, 2023
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 13, 2023
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 10, 2023
Lead Product(s) : Setanaxib
Therapeutic Area : Genetic Disease
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 17, 2022
Lead Product(s) : Setanaxib,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 ...
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 15, 2022
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 08, 2021
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : GKT137831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 08, 2021
Lead Product(s) : Setanaxib
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable