Drug Profile

Setanaxib - GenKyoTex

Alternative Names: GKT 831; GKT-137831

Latest Information Update: 14 Mar 2025

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At a glance

Originator GenKyoTex
Developer Calliditas Therapeutics; GenKyoTex
Class Amines; Anti-inflammatories; Antifibrotics; Antihyperglycaemics; Chlorinated hydrocarbons; Eye disorder therapies; Ketones; Osteoporosis therapies; Pyrazoles; Pyridines; Skin disorder therapies; Small molecules; Vascular disorder therapies
Mechanism of Action NOX1 protein inhibitors; NOX4 protein inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Idiopathic pulmonary fibrosis; Systemic scleroderma; Primary biliary cirrhosis; Hereditary nephritis
New Molecular Entity Yes

Phase II/III Primary biliary cirrhosis
Phase II Idiopathic pulmonary fibrosis; Squamous cell cancer
Phase I/II Hereditary nephritis
Discontinued Atherosclerosis; Bone disorders; Diabetic nephropathies; Eye disorders; Non-alcoholic steatohepatitis; Systemic scleroderma

14 Mar 2025 Discontinued - Phase-I for Diabetic nephropathies (In volunteers) in Switzerland (PO), before March 2025 (Calliditas Therapeutics pipeline, March 2025)
14 Mar 2025 Discontinued - Phase-II for Diabetic nephropathies in Germany, Czech Republic, Denmark, New Zealand, Poland, Canada, Australia, USA (PO), before March 2025 (Calliditas Therapeutics pipeline, March 2025)
12 Mar 2025 Discontinued - Preclinical for Non-alcoholic steatohepatitis in Switzerland (PO), before March 2025 (Calliditas Therapeutics pipeline, March 2025)

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