Daewoong Pharmaceutical said Wednesday it confirmed the safety of Dwj1563 in phase 1 clinical trials. Dwj1563 is a combination drug, mixing Envlo (enavogliflozin), designed to excrete sugar, with Zemiglo (gemigliptin), also known for its sugar-lowering properties.

The phase 1 study served as a bioequivalence test, demonstrating the statistical equivalence of the test drug to a marketed drug. It involved comparing a single pill of Dwj1563 to Envlo and Zemiglo administered separately.

Cross-validation in 40 randomized healthy adults showed that the safety and bioavailability of Dwj1563 were equivalent to that of Envlo and Zemiglo separately.

The company said that instead of taking two tablets of Envlo and Zemiglo, patients can safely take just one tablet of Dwj1563 to achieve the same effect.

Zemiglo is a DPP-4 inhibitor diabetes drug. DPP-4 inhibitors are insulin-dependent drugs that produce GLP-1 hormone, which stimulates insulin secretion and stays in the body for a longer period of time, increasing the amount of insulin to control blood sugar.

Envlo is an SGLT-2 inhibitor. SGLT-2 inhibitors control blood sugar by excreting sugar in the urine, regardless of insulin secretion. Envlo works in the kidneys and does not affect the pancreas, which secretes insulin, giving it the advantage of preserving the effectiveness of each drug when combined with a DPP-4 inhibitor.

By combining Envlo and Zemiglo, Daewoong plans to provide an effective treatment alternative for patients who have difficulty controlling their blood glucose levels with a single drug.

"Starting with Envlomet, our recently launched combination diabetes drug, we will focus on expanding our product lineup, including Dwj1563," said Lee Chang-jae, CEO of Daewoong Pharmaceutical. "With proven bioequivalence test, we will continue to grow Dwj1563 into a best-in-class diabetes drug in line with the growing demand for combination drugs."