Synokem Pharmaceutical Gets CDSCO Panel Nod To study Antidiabetic FDC Drug
New Delhi: With the condition of including more government sites distributed geographically, Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed-dose combination of the antidiabetic drug Linagliptin plus Metformin Hydrochloride film-coated bilayered tablet.
This recommendation came after Synokem Pharmaceutical presented the Phase IV clinical trial protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 24.04.2023.
Linagliptin is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels (hyperglycemia).
Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Metformin is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus, in particular, in overweight and obese people and those with normal kidney function. Metformin is a medicine used to treat type 2 diabetes and gestational diabetes.
At the recent SEC meeting for Endocrinology and Metabolism held on 23 November 2023, the expert panel reviewed the Phase IV clinical trial protocol of the FDC antidiabetic drug Linagliptin plus Metformin Hydrochloride film-coated bilayered tablet presented by Synokem Pharmaceutical.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase IV clinical trial with the condition to include more government sites, which should be geographically distributed.
In addition, the expert panel suggested that the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee.
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