Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin
New Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial study of the fixed-dose combination of the antidiabetic drug Sitagliptin Phosphate Monohydrate plus Empagliflozin in two strengths.
This came after Synokem Pharmaceuticals presented the proposal before the committee with a request to the present Phase III protocol in two strengths i.e. clinical trial Sitagliptin Phosphate Monohydrate IP 100mg/100mg plus Empagliflozin 25mg/10mg tablets and requested for bioequivalence (BE) study wavier.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. 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.
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney.
Empagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults and children 10 years of age and older with type 2 diabetes ( the condition in which blood sugar is too high because the body does not produce or use insulin normally).
At the recent SEC meeting for Endocrinology and Metabolism held on 22nd and 23rd August 2023, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial study and considered for BE study waiver.
In addition, the expert panel suggested that the result of the study should be presented before the committee for review.
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