Daewoong's DWP16001 targets synergistic effect with Zemiglo

Approved for phase III clinical trial of Metformin-Gemigliptin combination

There are already three approvals for Phase III

Daewoong

Daewoong's new SGLT-2 inhibitory diabetes drug candidate is aiming for synergy with another domestic drug.

 

The drug, first designated for expedited review, has been approved for three phase III clinical trials.

 

The MFDS approved a phase III clinical trial protocol for Daewoong Pharmaceutical's new diabetes drug candidate 'DWP16001 (Enavogliflozin)' on the 30th of last month.

 

This clinical trial is a Phase III therapeutic confirmation clinical trial conducted to evaluate the efficacy and safety of DWP16001 in patients with type 2 diabetes who have insufficient blood sugar control with Metformin and Gemigliptin.

 

The clinical trial hospital is Bucheon ST.

 

Mary’s Hospital.

 

It is already the third phase III approval.

 

In September, it received approval for Phase III clinical trials for both monotherapy and combination therapy with Metformin.

 

In addition, validation of the combination therapy with Metformin-Gemigliptin is in progress.

 

Gemigliptin is the active ingredient for Zemiglo, a new DPP-4 inhibitory diabetes drug developed by LG Chem.

 

Daewoong has been selling Zemiglo since 2016.

 

It also recently agreed to extend the joint sales until 2030.

 

As Daewoong started selling the single drug Zemiglo and the combination drug Zemimet, last year, it achieved sales of ₩100 billion for the first among Korean new drugs.

 

It is very interesting that Daewoong's SGLT-2 drug combination therapy selected a new domestic drug among DPP-4 drugs.

 

In the case of the SGLT-2 series drugs mentioned above, most of the combined DPP-4 drugs are imported new drugs.

 

Januvia (sitagliptin) and Onglyza (Saxagliptin) for Forxiga, Januvia (sitagliptin) for Suglat, Trajenta (linagliptin) for Jardiance and Januvia (sitagliptin) for Steglatro was validated through combination therapy.

 

In addition, if Daewoong sells Zemiglo for the next 10 years and a new drug SGLT-2 is released in the middle, the combination therapy is expected to produce synergies in terms of profitability.

 

The medical community argues that even if the SGLT-2 drug is administered in combination therapy clinical trials with one DPP-4 drug, the benefit should be made even if it is used in combination with another DPP-4 drug.

 

Daewoong's Enavogliflozin is expected to be used in combination with other DPP-4 drugs even if it is used in combination clinical trials with Gemigliptin.

 

Enavogliflozin is a drug that was selected for the first rapid review by the MFDS.

 

It has been operating an expedited screening system based on corporate application since September.

 

For drugs designated for expedited review, the approval review period is shortened by about 30 days (120 days → 90 days), and advance consultation is possible, so the supplementation rate is also lower.

 

The MFDS said that Daewoong was designated as an innovative pharmaceutical company and that Enavogliflozin was designated as a subject for rapid review because it was a Korean drug.