Setanaxib is under clinical development by GenKyoTex and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Setanaxib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Setanaxib overview

setanaxib (GKT-831; GKT-137831) is under development for the treatment of complications of diabetic kidney disease include diabetic nephropathy, fibrosis associated in head and neck cancer, prostate cancer, primary biliary cholangitis, idiopathic pulmonary fibrosis, liver fibrosis, kidney fibrosis, atherosclerosis, non alcoholic steatohepatitis, scleroderma, portal hypertension and kidney disease. The drug candidate is administered orally. It selectively targets NOX4 and NOX1 over expressed in cancer associated fibroblast (CAF).

GenKyoTex overview

GenKyoTex a subsidiary of Calliditas Therapeutics AB, is a biopharmaceutical company that develops NOX therapies. The company develops targeted NOX inhibitors and molecule therapeutics that inhibit the NOX family of enzymes. GenKyoTex’s lead product candidate, GKT831, a selective NOX1/4 inhibitor, is in phase II clinical trial in primary biliary cholangitis, type 1 diabetes and kidney disease, and idiopathic pulmonary fibrosis. GenKyoTex lead products are setanaxib, a NOX1 and NOX4 inhibitor, which are in Phase II trial. In addition, its products are used in the treatment of diabetic nephropathy. The company has operations in Switzerland and France. GenKyoTex is headquartered in Saint-Julien- en-Genevois, France.

For a complete picture of Setanaxib’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.