Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase II for Recurrent Head And Neck Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Recurrent Head And Neck Squamous Cell Carcinoma have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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 alport syndrome, kidney disease (nephropathy), primary biliary cholangitis (primary biliary cirrhosis), recurrent head and neck cancer squamous cell carcinoma, idiopathic pulmonary fibrosis. The drug candidate is administered orally. It selectively targets NOX4 and NOX1 over expressed in cancer associated fibroblast (CAF). It was also under development for the treatment of prostate cancer, liver fibrosis, kidney fibrosis, atherosclerosis, non alcoholic steatohepatitis, scleroderma, portal hypertension and kidney disease.

Calliditas Therapeutics overview

Calliditas Therapeutics develops, identifies and commercializes pharmaceutical products for rare and orphan diseases. The company’s pipeline products include Nefecon and setanaxib. Nefecon, a proprietary oral drug candidate for the treatment of IgA nephropathy. Setanaxib, an oral small molecule inhibitor being developed for the treatment of primary biliary cholangitis, idiopathic pulmonary fibrosis, alport syndrome, solid tumors. The company offers products under the brand name TARPEYO. Calliditas Therapeutics works in collaboration with healthcare providers, clinicians and research organizations. The company offers its products and services in Sweden, France, Switzerland and the US. Calliditas Therapeutics is headquartered in Stockholm, Sweden.

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

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.