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Regulatory authorization for new drug for first indication, defined as Novel Drug Approval by FDA, and Marketing Authorization for New Active Substance by EMA.

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Tambay V, Raymond VA,Voisin L, Meloche S,Bilodeau M

In preclinical models, ERR activation: Stimulates expression of genes associated with aerobic exercise adaptation Enhances mitochondrial biogenesis and oxidative respiration Increases fatty acid oxidation in skeletal and cardiac muscle Supports endurance capacity and metabolic flexibility Because of these effects, the compound has been described in the literature as an exercise mimetic a molecule that may reproduce certain biochemical signatures of physical training without the training stimulus itself