Alkem Labs Gets CDSCO Panel Nod for conducting Phase III study of Semaglutide tablet
New Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organization (CDSCO), for conducting a Phase III clinical trial of Semaglutide Tablets 3mg, 7mg and 14mg (Synthetic origin) for Type 2 Diabetes Mellitus.
This came after Alkem Laboratories presented Bioequivalence study report along with the revised Phase III clinical trial protocol (protocol vide no. ALK40/SEM3 Version No. 1.1, dated 19.02.2025 for Type 2 Diabetes Mellitus) before the Committee.
Earlier the Medical Dialogues Team had reported that Alkem Laboratories had gotten the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study and Phase III clinical trial of Semaglutide Tablets 3mg, 7mg & 14mg (Synthetic origin) for Type 2 Diabetes Mellitus.
However, in line with the above approval, the expert panel had opined that the firm should submit a BE Study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating.
Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control blood sugar. This medicine is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes, obesity, and heart or blood vessel disease.
Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms, like augmented insulin secretion (glucose-dependent), inhibition of glucagon release and suppressed hepatic gluconeogenesis, thereby reducing both fasting and postprandial glucose.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed Bioequivalence study report of Semaglutide Tablets 3mg, 7mg and 14mg (Synthetic origin) along with the revised Phase III clinical trial protocol (protocol vide no. ALK40/SEM3 Version No. 1.1, dated 19.02.2025 for Type 2 Diabetes Mellitus) presented by Alkem Laboratories.
After detailed deliberation, the Committee recommended accepting the BE study report and recommended conducting the Phase III clinical trial as per the revised protocol presented by the firm.
