CDSCO Panel grants Cadila Healthcare's protocol amendment for Saroglitazar Tablets

This approval came after the drug major firm presented its proposal for the revised protocol of the Phase IV clinical trial of Saroglitazar Tablets 4mg along with the summary of changes in the amended protocol before the committee.

Saroglitazar is a drug for the treatment of type 2 diabetes mellitus and dyslipidemia. It is approved for use in India by the Drug Controller General of India. Saroglitazar is indicated for the treatment of diabetic dyslipidemia and hypertriglyceridemia with type 2 diabetes mellitus not controlled by statin therapy.

Saroglitazar, a dual peroxisome proliferator activated receptor α/γ agonist, approved for diabetic dyslipidemia (DD), is potential therapeutic option for non-alcoholic fatty liver disease (NAFLD).

Saroglitazar is a first in class drug which acts as a dual PPAR agonist at the subtypes α (alpha) and γ (gamma) of the peroxisome proliferator-activated receptor (PPAR). Agonist action on PPARα lowers high blood triglycerides, and agonist action on PPARγ improves insulin resistance and consequently lowers blood sugar.

At the recent SEC meeting Gastroenterology & Hepatology held on January 17 2023, the expert panel reviewed the proposal presented by Cadila Healthcare about the protocol amendment of Phase IV clinical trial of the antidiabetic drug Saroglitazar Tablets 4mg.

After detailed deliberation, the committee recommended the grant of permission for amendment in already approved CT NOC Vide No.SND/152/2021 dated 17.11.2021 as per amended protocol (Protocol no. SARO.21.003, version No.5.0, dated 12.11.2022) as presented by the firm.

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