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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.