Daewoong Diabetes Drug 'Envlo' Attempts Expansion to Kidney Complications

Daewoong Pharmaceutical's diabetes treatment drug Envlo has embarked on an attempt to expand its indications to diabetic patients with kidney (renal) disease.

Daewoong Pharmaceutical's SGLT-2 inhibitor class diabetes treatment 'Envlo'
[Photo by Daewoong Pharmaceutical]

Daewoong Pharmaceutical announced on the 1st that the Ministry of Food and Drug Safety has approved an additional Phase 3 clinical trial plan for Envlo targeting type 2 diabetes patients with moderate chronic kidney disease.

The proportion of diabetic patients in Korea who also have kidney disease has been steadily increasing. According to the 2023 Diabetes Fact Sheet, 25.4% of diabetic patients aged 30 and over in Korea have kidney disease, meaning that one in four adult diabetic patients suffer from kidney disease as well.

Through this additional Phase 3 clinical trial approval, Daewoong Pharmaceutical plans to accelerate securing indications for diabetic patients with kidney disease. The diabetes medications that can be prescribed vary depending on kidney function. Currently, Envlo can only be prescribed to type 2 diabetes patients with normal kidney function or those with mild kidney disease. Daewoong Pharmaceutical aims to expand the prescription range to include patients with moderate kidney disease by confirming the efficacy and safety of Envlo in type 2 diabetes patients with moderate kidney disease through this additional Phase 3 trial, demonstrating improvement in glycated hemoglobin not only in mild but also in moderate kidney disease patients.

This clinical trial will involve 348 type 2 diabetes patients with moderate kidney disease. Patients will be divided into Envlo administration and placebo groups, with both patients and investigators blinded to the administered drugs. The trial will compare the effect of Envlo on reducing glycated hemoglobin over 24 weeks against the placebo group, and will also evaluate the long-term safety of Envlo over 52 weeks.

Choi Jong-won, Head of Development at Daewoong Pharmaceutical, said about this clinical trial, "The number of diabetic patients with kidney disease is steadily increasing, making this additional clinical trial noteworthy," and added, "We will continue to secure clinical evidence for Envlo to care for all patients suffering from kidney disease, a diabetic complication."