Daewoong Pharmaceutical Applies for Long-Term Phase 3 Trial of Diabetes New Drug 'Envlo' Triple Combination

Triple Combination Therapy of Enblo, Gemigliptin, and Metformin

Daewoong Pharmaceutical announced on the 4th that it has applied to the Ministry of Food and Drug Safety for a long-term Phase 3 clinical trial of the triple combination therapy of the sodium-glucose co-transporter (SGLT)-2 diabetes drug 'Envlo' (generic name: Inavogliflozin).

Daewoong Pharmaceutical's sodium-glucose co-transporter (SGLT)-2 diabetes new drug 'Envlo' (active ingredient: Inavogliflozin).
[Photo by Daewoong Pharmaceutical]

Daewoong Pharmaceutical plans to demonstrate the long-term safety and efficacy of combining three drugs?Envlo tablets 0.3 mg, gemigliptin, and metformin?over 12 months. Earlier in April, the coverage for combination therapy with SGLT-2 inhibitors was expanded.

According to Daewoong Pharmaceutical, as the number of diabetes patients in Korea steadily increases, the use of triple combination therapy is also rising. According to the Diabetes Fact Sheet published by the Korean Diabetes Association in 2022, triple or more combination therapies have increased by 38% over the past five years, showing the only upward trend compared to single or dual therapies.

Envlo demonstrated equal or superior efficacy with only 0.3 mg, which is less than one-thirtieth the dose of existing SGLT-2 inhibitors on the market. In a Phase 3 clinical trial conducted on patients with type 2 diabetes, Envlo proved superior HbA1c and fasting blood glucose reduction effects and safety compared to existing marketed drugs. Additionally, the proportion of patients whose HbA1c decreased by more than 0.5 percentage points compared to before treatment reached up to 82.9%, whereas this rate is about 40-60% for drugs in the same class, according to the company.

In particular, Envlo showed effects such as weight loss, blood pressure reduction, lipid profile improvement, and insulin resistance improvement in the approval clinical study. It also confirmed superior blood glucose-lowering effects and proteinuria improvement compared to drugs in the same class in type 2 diabetes patients with impaired renal function.

Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, "This long-term Phase 3 clinical trial application was made to respond to the changing treatment paradigm. Since diabetes drugs require long-term administration, we plan to expand various treatment options based on the excellent efficacy of Envlo."

This content was produced with the assistance of AI translation services.