Zydus Gets CDSCO Panel Nod to Conduct Phase IV Study of Nelarabine Injection
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to Zydus Lifesciences Limited to conduct a Phase IV clinical trial of Nelarabine Injection 250 mg/50 ml, as per the revised protocol submitted by the firm.
The decision was taken under file number ND/CT/25/000013, with the committee directing that the trial results be submitted to CDSCO for further review.
The recommendation follows the earlier SEC observation dated 09 April 2025, after which the company submitted a revised Phase IV clinical trial protocol for Nelarabine Injection. The updated protocol, Protocol No. C2B05522, Version 02 dated 08 May 2025, was placed before the committee during the meeting for detailed consideration.
After reviewing the revised submission, the committee found the protocol acceptable and recommended granting permission to conduct the Phase IV clinical trial strictly as per the protocol presented by the firm. The SEC further emphasised that the outcomes of the Phase IV study must be submitted to CDSCO for subsequent evaluation, underscoring the importance of continued post-marketing surveillance.
Nelarabine is a purine nucleoside analogue antineoplastic agent indicated for the treatment of relapsed or refractory T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), particularly in patients who have failed to respond to previous therapies. The drug is selectively toxic to T-lymphoblasts, where it interferes with DNA synthesis, leading to apoptosis of malignant cells.
Zydus Lifesciences Limited is one of India’s pharmaceutical companies with a strong presence in oncology, injectables, and specialty therapies. The company has been actively engaged in generating post-marketing clinical evidence to meet regulatory expectations for complex oncology products.
