Daewoong's new diabetes drug 'Envlo',

Long-term phase 3 trial of Met+Gemigliptin

Ministry of Food and Drug Safety approved clinical trials on the 13th

Preemptive response to the expansion of 3-drug therapy benefits

Envlo, a new diabetes drug developed by Daewoong Pharmaceutical, is entering long-term safety and efficacy testing of the Zemiglo three-drug therapy.

 

While triple therapy of the Metformin+SGLT2i+DPP4i has been approved for reimbursement since last April, Daewoong Pharmaceutical is expected to establish its position as a latecomer, Envlo, in the triple therapy through this long-term trial.

 

On the 13th, the Ministry of Food and Drug Safety approved the phase 3 clinical trial to evaluate the safety and efficacy of Envlo + Metformin + Gemigliptin applied by Daewoong Pharmaceutical.

 

Envlo is the first domestically produced SGLT-2 type diabetes drug developed by Daewoong Pharmaceutical.

 

It received approval in November 2022 and has been commercially released since May of this year.

 

Gemigliptin, which is included in the three-drug combination therapy along with metformin, is a new domestic diabetes drug of the DPP-4 series developed by LG Chem and is being jointly promoted in the market with Daewoong Pharmaceutical.

 

Daewoong Pharmaceutical confirmed the safety and effectiveness of the metformin and gemigliptin triple therapy through phase 3 clinical trials at the time of Envlo approval.

 

At that time, the clinical trial lasted 24 weeks.

 

The long-term clinical trial to be conducted this time will verify safety and effectiveness for 12 months.

 

Last month, Daewoong Pharmaceutical announced that it had applied for this clinical trial to the Ministry of Food and Drug Safety and that it was a preemptive market response following the expansion of coverage for combination SGLT-2 inhibitors in April.

 

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "This phase 3 was conducted to respond to the changing treatment paradigm.

 

As diabetes treatment is a representative drug that requires long-term use, we plan to expand various treatment options based on Envlo's excellent efficacy in the future." He explained.

 

Since its launch last May, Envlo has been supplied to large hospitals one after another and is expanding its market.

 

Last September, the two-drug combination drug 'Envlomet', which combines Envlo + Metformin, was also launched for reimbursement.

 

Daewoong Pharmaceutical plans to develop Envlo into a large blockbuster drug with sales of 100 billion won within three years.