Daewoong Pharmaceutical said on Sunday that it applied to the Ministry of Food and Drug Safety (MFDS) for a long-term phase 3 clinical trial to demonstrate the long-term safety and efficacy of Envlo (ingredient: enavogliflozin) 0.3-milligram tablets in combination with gemigliptin and metformin, for 12 months.

Envlo is the first homegrown sodium-glucose cotransporter 2 (SGLT2) diabetes drug in Korea and the nation's 36th newly developed drug.

In April, the coverage for SGLT2 inhibitors was expanded and Envlo received insurance coverage for treating three indications -- monotherapy, combination therapy with metformin, and combination therapy with metformin and gemigliptin. Subsequently in May, the company launched its SGLT2 inhibitor drug, Envlo 0.3mg (ingredient: enavogliflozin).

As the number of diabetes patients in Korea continues to increase, the use of three-drug combination therapy is on the rise. According to a report published by the Korean Diabetes Association in 2022, the use of three or more drug combinations has increased by 38 percent in five years, showing the only upward trend in contrast to single-drug and two-drug combinations.

"We filed this long-term phase 3 application in response to the changing treatment paradigm," said  Daewoong Pharmaceutical CEO Jeon Seng-ho. "As diabetes medications are drugs that require long-term use, we plan to expand various treatment options based on Envlo's superior efficacy."

Envlo demonstrated superior HbA1c and fasting plasma glucose-lowering efficacy and safety compared to existing marketed drugs, with up to 82.9 percent of patients achieving HbA1c reductions greater than 0.5 percentage points from baseline in the previous phase 3 trial conducted on type 2 diabetes patients.

This rate is typically seen in the 40-60 percent range for drugs in the same class, said a Daewoong Pharmaceutical company official.

In particular, Envlo's weight loss, blood pressure reduction, lipid profile improvement, and insulin resistance improvement as well as its superior glycemic lowering and proteinuria improvement compared to similar drugs in type 2 diabetes patients with reduced renal function, make Envlo a new treatment option for patients with inadequate glycemic control.