Expert Panel Rejects Zuventus' Trelagliptin PMS Plan, Seeks Higher Patient Enrolment
New Delhi: Zuventus Healthcare Limited's proposal for the active post-marketing surveillance (PMS) study of Trelagliptin Tablets 25 mg, 50 mg and 100 mg has been rejected, and the firm has been directed by the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO) to revise and resubmit the protocol with higher patient enrolment.
The proposal was reviewed in the SEC meeting held on July 24, 2025, in continuation of earlier SEC recommendations dated November 13, 2024, and condition no. 9 of the new drug permission granted for Trelagliptin.
According to the minutes, while the firm presented justification for the number of patients with renal impairment to be included in the PMS study, the committee noted that Phase III clinical trial data exists only for the 100 mg strength, with no Indian clinical data available for the 25 mg and 50 mg strengths. The justification provided by the firm for the proposed enrolment numbers was not accepted.
The SEC recommended that the PMS study should include at least 180 patients with moderate renal impairment for the 50 mg dose and at least 60 patients with severe renal dysfunction or end-stage renal disease for the 25 mg dose, to generate sufficient data in the Indian population.
Accordingly, Zuventus has been asked to submit a revised PMS study protocol to CDSCO within one month. The committee stated, “The proposed PMS study should include the specified patient numbers to generate sufficient data on the Indian population.”
Trelagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for the management of type 2 diabetes mellitus.
