CDSCO Panel Clears Abbott's Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Abbott Healthcare Pvt. Ltd. to conduct a Phase IV clinical trial for its fixed dose combination (FDC) antidiabetic formulation of Empagliflozin and Metformin Hydrochloride (Sustained Release) tablets, in strengths of 25 mg/10 mg + 1000 mg/1000 mg.
The clearance comes with a condition that the company must increase the number of trial sites and ensure geographic distribution across India.
This recommendation was made at the recent SEC (Endocrinology and Metabolism) meeting held on 22 April 2025, where the committee reviewed the Phase IV clinical trial protocol submitted by the firm in compliance with conditions of the earlier Form CT-23 approval dated 01 October 2024.
After detailed deliberation, the committee recommended:
“Permission be granted to conduct the proposed Phase IV clinical trial, provided that more sites are added and geographically distributed.”
The company is required to submit the Phase IV clinical trial report to CDSCO upon completion for further review by the committee.
Empagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in blood.
Also Read: Drug alert: CDSCO flags 60 formulations as not of standard quality
