Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream
New Delhi: Dr. Reddy's Laboratories Limited has received approval from the Subject Expert Committee (SEC) under CDSCO to conduct a Phase III clinical trial of its investigational dermatological product Tapinarof Cream 1%, aimed at treating plaque psoriasis.
The decision was made during the SEC’s 7th meeting held on 23rd July 2025 at CDSCO headquarters, New Delhi, where the firm presented its proposal for the grant of permission to manufacture and market the drug, along with the full Phase III clinical trial protocol.
The proposed trial is titled:
“A randomized, multi-center, double-blind, parallel group, three-arm, placebo-controlled trial to evaluate the clinical equivalence of Tapinarof cream 1% of Dr. Reddy’s Laboratories Ltd versus VTAMA® (Tapinarof cream 1%, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis”.
The study will be conducted under protocol number DRL-IND-NDA30-TAP/2024, version 3.0 dated 17.04.2025. It is designed to evaluate the clinical equivalence of Dr. Reddy’s Tapinarof formulation to the reference product VTAMA®, already approved internationally and marketed by Dermavant Sciences Inc.
Tapinarof is an aryl hydrocarbon receptor (AhR) agonist, a novel non-steroidal topical treatment for plaque psoriasis. Its mechanism involves modulating immune responses and skin barrier repair, offering a potential steroid-free alternative for patients with chronic skin conditions.
After reviewing the clinical protocol and related materials, and following detailed deliberation, the SEC found the submitted plan appropriate and aligned with regulatory expectations for comparative efficacy and safety evaluation.
“After detailed deliberation, the committee recommended for grant of permission to conduct Phase III clinical trial of drug Tapinarof Cream 1% as per protocol presented by the firm.”
