Daewoong wins Indonesian approval for diabetes drug Envlo

Daewoong Pharmaceutical's Envlo Tab (Daewoong Pharmaceutical)

Daewoong Pharmaceutical said Wednesday it has won regulatory approval in Indonesia for its type 2 diabetes treatment Envlo (enavogliflozin), marking its entry into Southeast Asia’s largest pharmaceutical market.

The drug was approved by Indonesia’s National Agency of Drug and Food Control, Daewoong said. Indonesia has an estimated 20.4 million adults living with diabetes as of 2024, ranking fifth globally, according to the International Diabetes Federation. The country’s diabetes treatment market is projected to reach about $380 million in 2025.

Daewoong said the approval expands treatment options for Indonesian patients while advancing its broader Southeast Asia growth strategy. The company plans to launch Envlo in additional regional markets, including the Philippines and Thailand, where the drug has already received regulatory clearance.

In a phase 3 clinical trial, Envlo demonstrated non-inferior blood sugar–lowering efficacy compared with dapagliflozin, an established SGLT-2 inhibitor, at a low daily dose of 0.3 milligram. Among Asian patients, 78.1 percent achieved normal glycated hemoglobin levels, compared with 65.7 percent for dapagliflozin. The drug also showed reductions in fasting plasma glucose and a 60 percent improvement in insulin resistance, while meeting long-term safety benchmarks.

SGLT-2 inhibitors lower blood sugar by blocking glucose reabsorption in the kidneys, increasing glucose excretion through urine. The drug class is also associated with additional benefits, including weight loss, lower blood pressure and protective effects on the heart and kidneys, the company said.

“The Indonesian approval is a significant step in expanding our presence in key Asian markets and adds momentum toward our goal of entering 30 countries by 2030,” said Daewoong CEO Park Seong-soo. “We will continue to strengthen our competitiveness through global approvals and provide better treatment options for diabetes patients worldwide.”