LG Chem begins development of Zemiglo + SGLT-2 inhibitor

The MFDS approved Phase I clinical trial for Gemigliptin & Dapagliflozin

LG Chem will develop a combination of DPP-4 inhibitor and SGLT-2 inhibitor.

 

Currently, three items are permitted as a combination, but no drug has been developed by a domestic pharmaceutical company.

 

According to the pharmaceutical industry on the 29th, the MFDS recently approved LG Chem's Phase I trial plan which comparing the pharmacokinetics, safety and tolerability when Gemigliptin 50mg and Dapagliflozin 10mg are administered respectively and together.

 

Zemiglo

Gemigliptin is a DPP-4 inhibitor developed by LG Chem itself.

 

It is Zemiglo.

 

Dapagliflozin is generic for AstraZeneca's SGLT-2 inhibitor Forxiga.

 

Currently, there are three products approved in Korea for the combination of DPP-4 inhibitor and SGLT-2 inhibitor.

 

No products have been developed by domestic companies yet.

 

Beringer Ingelheim's Glyxambi (Empagliflozin-Linagliptin) and AstraZeneca's Qtern (Dapagliflozin-Saxagliptin) were each approved in March 2017.

 

MSD's'Steagluzan (Citagliptin + Ertugliflozin)' was approved in September 2018.

 

If LG Chem succeeds in developing complex drugs, it will be the fourth drug in the Zemiglo series.

 

Currently, LG Chem possesses ▲DPP-4 inhibitor single ingredient Zemiglo ▲DM complex, Zemimet (Gemigliptin/Metformin) ▲DM and hyperlipidemia complex Zemiro (Gemigliptin/Rosuvastatin).

 

The total prescription amount for the three products last year was ₩97.9 billion.

 

This year, ₩56 billion worth was prescribed until the first half.

 

The products are likely to exceed ₩100 billion annually.

 

◆The key is whether DPP-4·SGLT-2 combination therapy benefits are recognized. The Korean Diabetes Association submitted an opinion to the government in April that a combination of DPP-4 inhibitors and SGLT-2 inhibitors would require benefits.

 

Prior to this, in 2018, the government tried to find a way to apply benefits.

 

In February of this year, LG Chem and Dong-A ST launched in June, and in June, Handok launched clinical trials.

 

In the case of LG Chem, it is to verify the combination therapy of Zemiglo and Dapagliflozin or Empagliflozin.

 

Dong-A ST also entered a combination clinical trial of its DPP-4 inhibitor, Suganon (Evogliptin) and Dapagliflozin or Empagliflozin.

 

Handok has also been approved for a clinical trial plan to verify the combination therapy of its DPP-4 inhibitor Tenelia (Teneligliptin) and SGLT-2 inhibitor.

 

An official in the pharmaceutical industry said, "If the government recognizes the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors as reimbursed items, it will be possible to prescribe combination drugs as well as combination therapy."