CDSCO Panel Approves BE Study for Alkem's Dapagliflozin, Pioglitazone, Metformin FDC, Seeks Revised Phase III Plan
New Delhi: Alkem Laboratories has received approval from the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) to conduct a bioequivalence (BE) study for its proposed fixed dose combination (FDC) antidiabetic tablet containing Dapagliflozin Propanediol Monohydrate (10mg + 10mg), Pioglitazone Hydrochloride (15mg + 15mg), and Metformin Hydrochloride ER (500mg + 1000mg).
The approval came during the SEC (Endocrinology & Metabolism) meeting held on May 14, 2025, where the firm presented its proposal along with the BE study design and Phase III clinical trial protocol.
Following a detailed review, the committee recommended the grant of permission to conduct the BE study. However, regarding the Phase III trial protocol, the committee emphasized the need for design balance, stating that:
"The control and test arms should have equal number of drugs."
Accordingly, the committee advised the company to submit the BE study report along with a revised Phase III clinical trial protocol to CDSCO for further evaluation.
About the Components of the FDC:
Dapagliflozin Propanediol Monohydrate: A sodium-glucose co-transporter 2 (SGLT2) inhibitor, dapagliflozin reduces glucose reabsorption in the kidneys, helping to control blood sugar in patients with type 2 diabetes.
Pioglitazone Hydrochloride: Belonging to the thiazolidinedione (TZD) class, pioglitazone improves insulin sensitivity and enhances glucose uptake in peripheral tissues.
Metformin Hydrochloride ER: A biguanide-class drug that reduces glucose production in the liver and improves insulin-mediated glucose utilization.
All three agents are established oral antidiabetic drugs used to manage type 2 diabetes mellitus, particularly when lifestyle changes and monotherapy prove insufficient.
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