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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.
Lead Product(s): Setanaxib
Therapeutic Area: Genetic Disease Product Name: GKT137831
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2023
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.
Lead Product(s): Setanaxib
Therapeutic Area: Genetic Disease Product Name: GKT137831
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2023
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.
Lead Product(s): Setanaxib
Therapeutic Area: Genetic Disease Product Name: GKT137831
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2023
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).
Lead Product(s): Setanaxib,Pembrolizumab
Therapeutic Area: Oncology Product Name: GKT137831
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
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).
Lead Product(s): Setanaxib,Pembrolizumab
Therapeutic Area: Oncology Product Name: GKT831
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2021
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2021
Details:
The Phase 1 study Showed that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The study assessed the safety and pharmacokinetics of oral setanaxib at select doses in 46 healthy adult male and female subjects.
Lead Product(s): Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT137831
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2021
Details:
Transaction adds orphan pipeline asset and platform in inflammation and fibrosis. Genkyotex’s lead clinical candidate, setanaxib, is in development for Primary Biliary Cholangitis.
Lead Product(s): Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genkyotex
Deal Size: $37.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition August 13, 2020
Details:
This Phase 1 study will evaluate setanaxib at doses up to 1600 mg/day in up to 54 subjects. Genkyotex is currently discussing the registration strategy for setanaxib in PBC with FDA and EMA.
Lead Product(s): Setanaxib
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
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