Two major Indian pharmaceutical companies have received regulatory approval to advance their semaglutide development programs, marking significant progress in bringing generic versions of the blockbuster GLP-1 receptor agonist to market.
Macleods Receives Conditional Approval for Weight Management Indication
At the 8th meeting of 2025 held on April 22nd, the Central Drugs Standard Control Organisation (CDSCO) expert committee reviewed Macleods Pharmaceuticals' submissions for semaglutide treatment in weight management. The panel approved both the bioequivalence study protocol (Protocol No. BEQ-3990-SEMA-2025, Version 01) and Phase III clinical trial protocol (Protocol No. CT-065-SEMA-2025, Version 01) in principle.
However, the approval comes with a critical condition. The committee directed the firm to submit and present preclinical subacute toxicity study report before initiating the bioequivalence study. "After detailed deliberation, the Committee in principle agreed with presented BE protocol and Phase III CT protocol and recommended that firm should submit and present preclinical subacute toxicity study report before initiation of BE study," the panel noted.
According to the submission, the preclinical subacute toxicity study involving two species is currently ongoing. The SEC's final approval remains conditional upon the submission of this toxicity study data.
Macleods' application covers multiple strengths of semaglutide injection, including 0.25 mg, 0.5 mg, and 1 mg formulations in 4 mg/3 mL pre-filled pens, as well as 1.7 mg and 2.4 mg strengths in 9.6 mg/3 mL pre-filled pens.
Intas Pharma Advances to Phase III for Diabetes Treatment
In a separate development, Intas Pharma received approval to conduct Phase III trials for semaglutide injection in patients with Type 2 Diabetes Mellitus. At the SEC meeting for Endocrinology and Metabolism held on May 14th, 2025, the expert panel reviewed the company's full submission, which included the Phase III trial proposal and bioequivalence study report.
"After detailed deliberation, the committee recommended accepting the BE study report and conducting the Phase III clinical trial as per the submitted protocol," the SEC stated. The trial will be conducted according to protocol no. 0130-24, version 1.0, dated February 3rd, 2025.
Intas Pharma's proposed semaglutide injection formulations include multiple strength options: 0.68 mg/mL (1 mg/1.5 mL), 1.34 mg/mL (2 mg/1.5 mL and 4 mg/3 mL), 2.27 mg/mL (6.8 mg/3 mL), and 3.2 mg/mL (9.6 mg/3 mL) in prefilled pens.
Mechanism and Therapeutic Benefits
Semaglutide, an incretin mimetic classified as a glucagon-like peptide-1 (GLP-1) receptor agonist, works by mimicking the hormone GLP-1. The drug stimulates insulin secretion, reduces hepatic glucose output, slows gastric emptying, and suppresses appetite. It helps regulate blood sugar by enhancing glucose-dependent insulin secretion, suppressing glucagon, and delaying gastric emptying.
These mechanisms support both glycemic control and weight management, with semaglutide being associated with improved glycemic control, weight loss, and a potential reduction in cardiovascular risk. The drug's dual benefits make it valuable for treating both Type 2 diabetes and obesity, as reflected in the different therapeutic focuses of the two Indian companies' development programs.
