Daewoong's 'N-Blo' Receives Clinical Approval to Confirm Long-Term Efficacy of Triple Combination Therapy

Daewoong Pharmaceutical announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for a long-term Phase 3 clinical trial of the triple combination therapy of ‘Envlo’ (active ingredient: Inavogliflozin), a new diabetes treatment drug in the sodium-glucose co-transporter (SGLT)-2 inhibitor class. Envlo, officially launched in May, is the 36th domestically developed new drug and the first SGLT-2 inhibitor diabetes treatment developed by Daewoong Pharmaceutical in Korea.

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

In this clinical trial, Daewoong Pharmaceutical plans to be the first to demonstrate the safety and efficacy of the long-term triple combination therapy of Envlo, Gemigliptin (a Dipeptidyl Peptidase (DPP)-4 inhibitor), and Metformin in patients with type 2 diabetes whose blood sugar control is insufficient with Gemigliptin and Metformin.

Previously, a 24-week Phase 3 clinical trial on the triple combination therapy was conducted last year to prove safety and efficacy. This upcoming trial will extend to a 12-month long-term study to confirm the long-term efficacy and safety of the triple combination therapy in type 2 diabetes patients with moderate, mild, or normal kidney function.

Recently, the paradigm of diabetes treatment has been shifting from monotherapy and dual combination therapy to triple or more combination therapies. According to the ‘2022 Diabetes Fact Sheet’ by the Korean Diabetes Association, the use of triple or more combination therapies steadily increased from 25.5% in 2011 to 38.0% in 2019, while the proportions of monotherapy and dual combination therapy decreased by 4.6 percentage points and 7.1 percentage points, respectively. Furthermore, since April, the reimbursement criteria for combination therapies including SGLT-2 inhibitors have been expanded, allowing various combinations such as ▲Metformin + SGLT-2 inhibitor + DPP-4 inhibitor ▲Metformin + SGLT-2 inhibitor + Thiazolidinedione (TZD), which is expected to promote more active use of combination therapies.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “This clinical trial approval is of great industrial significance and market value as it involves a combination clinical trial of a domestically developed DPP-4 inhibitor, Gemigliptin, which is widely prescribed, and a domestically developed SGLT-2 inhibitor new drug.” He added, “With the expansion of reimbursement for combination therapies in diabetes treatment, we will accelerate the expansion of our product lineup to provide diverse treatment options in line with the paradigm shift in diabetes treatment.”

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