Synokem Pharma Gets CDSCO Panel Nod To Study Antidiabetic FDC

Sitagliptin belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control which is demonstrated by reduced glycosylated hemoglobin (HbA1c).

Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose absorbed from food and the amount of glucose made by the liver.

At the recent SEC meeting for endocrinology and metabolism held on 24th January 2023, the expert panel reviewed the proposal presented with the BE study protocol and Phase III clinical trial protocol of the FDC antidiabetic drug.

After detailed deliberation, the committee recommended the grant of permission to conduct the BE study with the condition that a doctor (MD Medicine) should be present during the study.

Accordingly, the expert panel suggested that the firm should submit a BE study report for review by the committee to make further decisions on the Phase III clinical trial protocol.

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