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  • Sun Pharma Labs gets...

Sun Pharma Labs gets CDSCO Panel nod to study synthetic-origin Semaglutide solution for injection

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-05T21:11:48+05:30  |  Updated On 5 Jun 2024 9:11 PM IST
Sun Pharma Labs gets CDSCO Panel nod to study synthetic-origin Semaglutide solution for injection
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New Delhi: Responding to the proposal for granting permission to manufacture and market semaglutide solution for injection (synthetic origin), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the drug major Sun Pharma Labs to conduct a bioequivalence study and phase III clinical trial of Semaglutide solution for injection (synthetic origin) 2mg/1.5ml, 4mg/3ml, 8mg/3ml.

This came after Sun Pharma Labs presented their proposal for a grant of permission to manufacture and market of Semaglutide solution for injection (Synthetic origin) (2mg/1.5ml) 1.34mg/ml, (4mg/3ml)1.34mg/ml, (8mg/3ml) 2.68mg/ml) along with the Phase III clinical trial and bioequivalence study protocol before the Committee.

Sun Pharma Labs has requested approval to manufacture and market semaglutide solutions for injection for the following indications:

1. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
2. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.

GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas.

Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.

Also Read:Semaglutide tied to meaningful weight loss, waist size reduction and CV benefits in non diabetic overweight adults: Study

In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via a reduction in appetite and food cravings after semaglutide administration.

At the recent SEC meeting for endocrinology and metabolism held on May 16, 2024, the expert panel reviewed the proposal presented by Sun Pharma Labs for a grant of permission to manufacture and market semaglutide solution for injection (synthetic origin).

In line with the above, the firm has informed that semaglutide solutions for injection (rDNA origin) of 0.25 mg/0.5 ml, 0.5 mg/0.5 ml, 1 mg/0.5 ml, 1.7 mg/0.75 ml, and 2.4 mg/0.75 ml have already been approved by the CDSCO on April 20, 2022.
After detailed deliberation, the committee recommended a grant of permission to conduct a bioequivalence study and phase III clinical trial.
Furthermore, the expert panel suggested that the firm submit a bioequivalence report for review by the SEC committee before initiating the Phase III clinical trial.

Also Read:BMS Gets CDSCO Panel Nod to Study Deucravacitinib

semaglutidecdscosun pharma labstype 2 diabetes mellitusglucagon-like peptide-1
Dr. Divya Colin
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

    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

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