Setanaxib is under clinical development by GenKyoTex and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Setanaxib’s likelihood of approval (LoA) and phase transition for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) took place on 29 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Setanaxib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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. The drug candidate is based on the NOX screening platform.

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.

Quick View Setanaxib LOA Data

Report Segments
  • Innovator
Drug Name
  • Setanaxib
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Metabolic Disorders
  • Oncology
  • Respiratory
Key Developers
Highest Development Stage
  • Phase III

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.