INCY · 10-Q · 2026Q3 · Full report

OPZELURA Product Expansion

INCYTE CORP · 2026-10-29 · Importance 35 · Surprise 42

OPZELURA (ruxolitinib) cream gained European Commission approval in July 2026 for moderate atopic dermatitis in adults for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate. The filing identifies it as the first steroid-free topical JAK inhibitor approved in the EU for adults with moderate atopic dermatitis. This represents OPZELURA’s second approved indication in the EU, in addition to its existing EU indication for nonsegmental vitiligo with facial involvement.

Key facts

• In July 2026, the European Commission approved OPZELURA for moderate atopic dermatitis in adults for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate; it was the EU’s first approved steroid-free topical JAK inhibitor for adults with moderate AD and its second approved indication in the EU. source
• In September 2025, the FDA approved OPZELURA for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised children aged 2 years and older whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable. source
• In July 2022, the FDA approved OPZELURA for topical treatment of nonsegmental vitiligo in adults and pediatric patients aged 12 years and older; it was the first and only FDA-approved treatment for repigmentation of vitiligo lesions and was approved for continuous use with no duration limits. source
• In April 2023, the European Commission approved OPZELURA for topical treatment of nonsegmental vitiligo with facial involvement in adults and adolescents aged 12 years and older. source
• In October 2024, Health Canada granted a Notice of Compliance to OPZELURA cream 1.5% for topical treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo in patients aged 12 years and older. source