Imeglimin Hydrochloride

The results of the clinical studies of Imeglimin in patients with type 2 diabetes mellitus demonstrated the promising efficacy of Imeglimin both in monotherapy and combination therapies and indicated its acceptable safety. Based on these results, the proposed indication of "type 2 diabetes mellitus" is acceptable.

Imeglimin's mechanism of action involves dual effects: (a) amplification of glucose-stimulated insulin secretion (GSIS) and preservation of β-cell mass; and (b) enhanced insulin action, including the potential for inhibition of hepatic glucose output and improvement in insulin signalling in both liver and skeletal muscle. At a cellular and molecular level, Imeglimin's underlying mechanism may involve correction of mitochondrial dysfunction, a common underlying element of T2D pathogenesis. It has been observed to rebalance respiratory chain activity (partial inhibition of Complex I and correction of deficient Complex III activity), resulting in reduced reactive oxygen species formation (decreasing oxidative stress) and prevention of mitochondrial permeability transition pore opening (implicated in preventing cell death). In islets derived from diseased rodents with T2D, Imeglimin also enhances glucose-stimulated ATP generation and induces the synthesis of nicotinamide adenine dinucleotide (NAD+) via the 'salvage pathway'. In addition to playing a key role as a mitochondrial co-factor, NAD⁺ metabolites may contribute to the increase in GSIS (via enhanced Ca⁺⁺ mobilization). Imeglimin has also been shown to preserve β-cell mass in rodents with T2D. Overall, Imeglimin appears to target a key root cause of T2D: defective cellular energy metabolism. This potential mode of action is unique and has been shown to differ from that of other major therapeutic classes, including biguanides, sulphonylureas and glucagon-like peptide-1 receptor agonists.

The usual adult dosage is 1000 mg of Imeglimin Hydrochloride administered orally twice daily in the morning and evening.

Store in a cool (below 30°C) & dry place protected from the light. Keep away from the reach of children.