CDSCO Panel Rejects Phase III Trial of QL2107 Injection Proposed by Syneos Health
New Delhi: In a setback to Syneos Health India Private Limited, the Indian arm of the global contract research organization Syneos Health, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has rejected its Phase III clinical trial proposal for QL2107 Injection.
The company had submitted Phase III clinical study protocol no. QL2107-102, version 1.0 dated 03 March 2025 for review. However, the expert panel raised concerns regarding the study design and absence of efficacy endpoints.
After detailed deliberation, the committee opined that, "the proposed clinical trial is focused completely on Pharmacokinetic (pK) parameters. Moreover, primary objective and secondary objective of phase-III study protocol has not been demonstrated for confirmation of therapeutic benefit and efficacy end point. Hence, the committee didn’t recommend to conduct the clinical trial in India.”
Syneos Health, headquartered in the United States, is a global clinical research organization (CRO) that partners with pharmaceutical and biotechnology companies to design and run clinical trials worldwide.
The committee’s rejection signals that the trial, in its current form, does not meet India’s regulatory expectations for Phase III studies, which require demonstration of therapeutic efficacy beyond pharmacokinetics.
