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.