Sun Pharma Wins CDSCO Panel Approval for Phase III Vitiligo Trial of Ruxolitinib Cream
New Delhi: Based on the justification presented by the pharmaceutical major Sun Pharmaceutical Industries, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted approval for conducting the Phase III clinical study of Ruxolitinib cream 1.5% w/w for the topical treatment of non-segmental vitiligo in adult and pediatric patients 12 years of age and older.
This came in line with the earlier SEC recommendation dated 22.04.2025, where the expert panel suggested, "The firm needs to justify the selection of decapeptide as the comparator arm."
Ruxolitinib is a Janus kinase (JAK) inhibitor and Ruxolitinib cream 1.5% w/w is approved for the topical treatment of non-segmental vitiligo in adult and pediatric patients 12 years of age in the USA in July 2022.
Non-segmental vitiligo, also known as generalized vitiligo, is the most common type of vitiligo, characterized by symmetrical white patches on both sides of the body. These patches can appear on various areas, including hands, arms, feet, and the genital area. The condition is caused by the autoimmune destruction of melanocytes, the cells responsible for producing skin pigment.
At the earlier SEC meeting for dermatology and allergy, Sun Pharmaceutical Industries presented the proposal for manufacturing and marketing of Ruxolitinib cream 1.5% w/w for the topical treatment of non-segmental vitiligo in adult and pediatric patients 12 years of age and older, along with the proposal for the conduct of the Phase III clinical study vide protocol No. ICR/24/008 Version 1.0 dated 22/Oct/2024 before the committee.
Regarding the above, the expert panel noted that the mechanisms of action of the comparator arm decapeptide and the proposed Ruxolitinib cream 1.5% w/w are different. In line with this, at the earlier meeting the firm was asked to justify the selection of decapeptide as the comparator arm.
Now in continuation, at the recent SEC meeting, the firm presented justification on the selection of the comparator arm and the standardization of sunlight/commercial UVB light.
After detailed deliberation, the committee recommended the approval to conduct the Phase III clinical study as per the protocol presented by the firm.
