Daewoong Pharmaceutical announced on May 27 that its type 2 diabetes treatment, Envlo 0.3 mg (generic name: enavogliflozin), has received marketing approval in Mexico.
With this latest milestone, Daewoong Pharmaceutical has secured marketing authorization in seven of the 12 Latin American countries where it has applied for clearance. The approved nations now include Mexico, Ecuador, El Salvador, Guatemala, Honduras, the Dominican Republic, and Panama.
Daewoong Pharmaceutical has steadily expanded its commercial footprint for Envlo by teaming up with Arcera (formerly Moksha8), a regional partner with a robust distribution network across Latin America. The company has signed supply agreements for the drug with 12 major nations in the region, including its largest markets, Brazil and Mexico, effectively accelerating its push into local markets.
Mexico exhibits one of the highest prevalences of diabetes in Latin America. According to the International Diabetes Federation (IDF), the number of individuals diagnosed with diabetes is rising sharply across the region, driven by rapid urbanization leading to reduced physical activity, a shift toward high-calorie diets centered on ultra-processed foods, and a growing obese population.
Envlo is an SGLT-2 (sodium-glucose cotransporter 2) inhibitor-class treatment developed as South Korea’s 36th homegrown new drug. It works by lowering blood glucose levels through the inhibition of the SGLT-2 protein, which is responsible for glucose reabsorption in the kidneys. Beyond strong glucose-lowering efficacy and safety, the SGLT-2 inhibitor class is drawing significant clinical attention for its therapeutic benefits in managing kidney disease and heart failure, making it highly competitive in the Latin American market.
Notably, due to its high selectivity for the SGLT-2 protein, Envlo demonstrated glucose-lowering efficacy comparable or superior to existing SGLT-2 inhibitors from global big pharma, even at a low dose of 0.3 mg—which is approximately one-thirtieth of the dosage required by competing treatments. It also highlighted clear strengths in managing broader metabolic conditions, including weight loss and blood pressure improvement.
Park Sung-soo, CEO of Daewoong Pharmaceutical, said, “This approval in Mexico is an important turning point that validates our strategic expansion into the Latin American market, a goal we have meticulously pursued alongside our global partner.”
