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Omzotirome (formerly codenamed TRC150094) is a synthetic small molecule and functional analog of iodothyronines (thyromimetic) that acts as a mitochondrial modulator and metabolic modulator. It is designed to restore metabolic flexibility by improving insulin resistance, dysglycemia, dyslipidemia, and hypertension. Omzotirome increases energy expenditure and mitochondrial fatty acid oxidation in preclinical models, leading to reduced adiposity and improved cardiovascular risk factors. The drug has shown efficacy in reducing visceral fat accumulation, hepatic steatosis, progression of nephropathy, and preserving cardiac function in animal studies. Its mechanism involves increased activity of electron transport chain complexes II and V as well as sirtuin 1 activation independent of the AMPK-ACC-malonyl CoA pathway. Omzotirome is being developed primarily for the treatment of cardiometabolic-based chronic disease (CMBCD), including diabetes mellitus type 2, hypertension, dyslipidemia (as adjunctive therapy), with clinical trials reaching Phase III status in India[1][5][6][7].
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