CDSCO panel rejects Synokem Pharma proposal for oral antidiabetic drug Imeglimin

New Delhi: Rejecting the drug major Synokem Pharma's proposal for oral anti-diabetic medication Imeglimin 500mg and 1000mg Tab, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has opined that the firm should submit the detailed non-clinical and clinical data safety and efficacy of the drug.

This came after the pharma major, Synokem Pharma, presented their proposal for the manufacturing and marketing of the drug Imeglimin 500 mg and 1000 mg tablets along with the Phase III clinical trial protocol and BA/BE study protocol before the committee. 

In response to this, the committee further directed the firm to justify the proposed clinical trial using the said drug.

Imeglimin, developed by Poxel,  is a first-in-class, novel, oral antidiabetic investigational agent for type 2 diabetes treatment. Its mode of action is distinct from all other antihyperglycemic classes; imeglimin's mechanism involves the targeting of mitochondrial bioenergetics and improving mitochondrial function. It was approved for use in Japan in June 2021 under the brand name TWYMEEG.

Earlier, the Medical Dialogues Team had reported that a study found patients with type 2 diabetes (T2D) who received twice-daily 100mg of imeglimin monotherapy showed significant improvements in blood sugar control versus those who received placebo. Further, imeglimin monotherapy showed the same safety profile as placebo.

In a press release earlier this year, biopharmaceutical company Poxel stated that the drug has a glucose-lowering effect via both a pancreatic action that promotes glucose concentration-dependent insulin secretion and an extra-pancreatic action that improves glucose metabolism in the liver and skeletal muscle (gluconeogenesis suppression and glucose uptake improvement) via an action on mitochondria.

At the latest SEC meeting for Endocrinology & Metabolism dated October 26,2021, the CDSCO expert panel extensively evaluated Synokem Pharma's proposal for manufacturing and marketing of the drug Imeglimin 500 mg and 1000 mg tablets along with the Phase III clinical trial protocol and BA/BE study protocol.

After detailed deliberation, the committee opined that the firm should submit the following and present the same before the committee for further consideration:

1. Detailed non-clinical and clinical data of safety and efficacy of the drug.

2. Justification for the proposed clinical trial with the drug including 1000mg Tab, since this strength is not approved anywhere in the world & regulatory status of the drug in other countries.