CDSCO Panel Seeks More Safety Data from Raptim Research on Lenalidomide Patch
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked Raptim Research Pvt Ltd to provide additional safety data before proceeding with clinical studies of Lenalidomide TDS 8% (LLD-TDS-009 patch 50 cm² with 81 cm² overlay) developed using Derma Roller technology.
In reference to the earlier SEC recommendation dated July 8, 2025, the firm presented its justification for conducting the proposed clinical study.
However, the committee found that the data and justification submitted were insufficient to establish the safety and tolerability of the higher-strength Lenalidomide transdermal system (TDS) 8% patch in healthy adult male subjects.
After detailed review, the SEC advised that the firm must first submit safety data from studies using low-strength Lenalidomide TDS 5% employing Derma Roller technology before initiating any higher-strength (8%) studies in humans. The committee stated that only after reviewing these data would it consider the firm’s request for conducting trials on the higher concentration patch.
Lenalidomide is an immunomodulatory drug primarily used in the treatment of multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma. It works by modifying the body’s immune response and inhibiting the growth of cancer cells. Traditionally available as oral capsules, the development of a transdermal patch represents an innovative approach intended to improve patient compliance, ensure controlled drug delivery, and potentially reduce systemic side effects.
Raptim Research Pvt Ltd, a clinical research organization based in India, specializes in conducting bioavailability, bioequivalence, and clinical trials for novel drug delivery systems. The company has been exploring advanced drug delivery technologies such as transdermal therapeutic systems to enhance safety and efficacy profiles of existing therapies.
