Alkem Laboratories Gets CDSCO Panel Nod To study Semaglutide tablet for Type 2 Diabetes Mellitus

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-09T18:00:36+05:30 | Updated On 9 March 2025 6:00 PM IST

New Delhi: Alkem Laboratories has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalance (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 opined that the firm should submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III clinical trial.

This came after Alkem Laboratories presented BE study protocol vide no. BIOS/2024/128, Version No. 01, Dated 17.07.2024 and Phase III CT study protocol vide no. ALK40/SEM3 Version No. 1.0, dated 16.08.2024 for Type 2 Diabetes Mellitus before the Committee.

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 held on 6th February 2025, the expert panel reviewed BE study protocol vide no. BIOS/2024/128, Version No. 01, Dated 17.07.2024 and Phase III CT study protocol vide no. ALK40/SEM3 Version No. 1.0, dated 16.08.2024 for Type 2 Diabetes Mellitus before the Committee.

After detailed deliberation, the Committee recommended the grant of permission to conduct the BE study and Phase III clinical trial with the following changes in the CT protocol:

1.Retinal examination (fundoscopy) shall be done periodically.
2. Rescue criteria and medication need to be defined in the protocol.

Furthermore, the expert panel suggested that the firm should submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III clinical trial.

Also Read: Hetero Labs Gets CDSCO Panel Nod To Study Antipsychotic Drug Brexpiprazole Tablets

semaglutidesemaglutide drugscdscoAlkem Laboratoriesdiabetes mellitus

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751