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- Setanaxib (development code GKT-831) is an experimental orally bioavailable dual inhibitor of NADPH oxidase isoforms NOX4 and NOX1. Setanaxib is a member of the chemical series. The compound is the only specific that has entered into clinical trials. Setanaxib has demonstrated biological activity in a number of in vitro and in vivo animal pharmacological models including squamous cell carcinoma of the head and neck, diabetic nephropathy, retinopathy, atherosclerosis, liver fibrosis, osteoporosis, pulmonary hypertension, and idiopathic pulmonary fibrosis. This drug candidate has been investigated in humans in a Phase 2 proof-of-concept trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in diabetic nephropathy. Setanaxib was developed by Genkyotex, a French biotech company based in Archamps. In 2020, Calliditas Therapeutics AB acquired a controlling interest in Genkyotex, which was delisted and became a fully owned subsidiary of Calliditas in October 2021. Calliditas, a commercial stage biotech company headquartered in Stockholm, is currently developing setanaxib in two clinical trials in human patients. (en)
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