Daewoong files diabetes drug Envlo in 7 additional countries

Daewoong Pharmaceutical said it has submitted regulatory filings for its novel diabetes drug Envlo (ingredient: enavogliflozin) in seven additional countries -- six in Latin America plus Russia -- as part of its global expansion strategy.

According to the company, Envlo applications have been submitted in Costa Rica, Honduras, the Dominican Republic, Panama, El Salvador, and Guatemala, along with Russia. These filings bring the total number of countries where Envlo has entered or is in the process of entering to 19.

Daewoong's current regulatory push supports its broader “global first-in-class, 1 trillion won” strategy, which aims for Envlo to enter 30 markets worldwide by 2030.

Envlo, Korea’s first homegrown SGLT-2 inhibitor, is a next-generation oral antidiabetic drug developed by Daewoong. The SGLT-2 (sodium-glucose co-transporter 2) inhibitor class works by preventing the reabsorption of glucose and sodium in the kidneys, promoting their excretion through urine.

This mechanism not only improves blood glucose control but also offers potential benefits for blood pressure, renal function, cardiovascular health, and weight management, positioning SGLT-2 inhibitors as a transformative class in diabetes therapy.

Following its first international marketing approval in Ecuador last year, Daewoong has moved quickly to expand across Latin America, now targeting Russia and the broader Eurasian region. The company noted that approval in Russia could facilitate subsequent market entries into other CIS (Commonwealth of Independent States) countries such as Kazakhstan and Belarus, due to harmonized regulatory pathways.

According to market research firm IQVIA, the diabetes drug market in Latin America reached approximately 5.69 trillion won in 2023, while the Russia and CIS region accounted for roughly 1.2 trillion won, totaling an estimated 7 trillion won.

Within this market, the SGLT-2 inhibitor segment is experiencing rapid growth. In Latin America, the SGLT-2 category nearly doubled from 603.3 billion won in 2021 to 1.2 trillion won in 2023. In Russia and the CIS, it surged from 136.3 billion won to 330 billion won over the same period, representing a 142 percent increase.

“Envlo’s global expansion is about more than just market entry—it’s about delivering an innovative, patient-centered diabetes solution to people around the world,” Daewoong Pharmaceutical CEO Park Seong-soo said. “With our first approval in Ecuador as a launchpad, we will intensify our efforts in Latin America and Russia and remain focused on achieving our 30-country milestone by 2030.”