Chong Kun Dang's CKD-306 is approved for phase I

2016년에는 약물상호작용 임상 진행…본격 개발 착수

Duvie, a new diabetes drug made by Chong Kun Dang

Chong Kun Dang is continuing to develop a combination of diabetes drug 'Duvie' and DPP-4 inhibitor 'Sitagliptin'.

 

In 2016, Chong Kun Dang, a candidate for the development of a combination drug known through clinical approval of drug interactions, was recently approved for phase I clinical trials and is now in full swing.

 

The Ministry of Food and Drug Safety approved the Phase I clinical trial plan for CKD-396 by Chong Kun Dang on the 21st.

 

CKD-396 is known to be a combination of Lobeglitazone, a diabetes drug called 'Duvie' and Sitagliptin, one of the DPP-4 inhibitor.

 

In March 2016, a phase I trial protocol for drug interactions has already been approved.

 

The trial will be conducted at Severance Hospital.

 

The control drug is Januvia(100mg Sitagliptin phosphate hydrate) and Duvie 0.5 mg (Lobeglitazone sulfate).

 

26 healthy adults were compared with the pharmacokinetics and safety of CKD-396 and the control group.

 

Clinical trials are scheduled from February to December.

 

Duvie by Chong Kun Dang is a domestic new drug (No.

 

20) approved in July 2013.

 

It is a Thiazolidinediones-based diabetes treatment drug that increases insulin reactivity, reduces blood sugar levels, and maintains pancreatic function.

 

Chong Kun Dang has continued to develop complexes since Duvie was approved.

 

In June 2016, Duvimet (Lobeglitazone sulfate-Metformin Hydrochloride), which was combined with Metformin hydrochloride, the first treatment for type 2 diabetes, was approved.

 

The development of a combination of DPP-4-based therapeutic agents, Sitagliptin, is also part of the lineup.

 

Pioglitazone (brand name: Actos by Takeda), already a competitor of Duvie, is commercially available as 'Nesina act', a combination of DPP-4 inhibitor, Alogliptin (brand name: Nesina by Takeda).

 

Nesina act was approved in October 2014, and recorded last year's outpatient prescription amount of ₩11 billion based on UBIST, showing off as a blockbuster.

 

In the medical field, the combination of Thiazolidinediones and DPP-4 series doubles the effect of diabetic treatment and is used as a treatment option.

 

There are also several clinical data that show actual results.

 

As a result, the Lobeglitazone-Sitagliptin combination may be useful in patients.

 

It is noteworthy whether Chong Kun Dang's clinical research conducted in 2016 will bear the final commercialization.