Pfizer's Litfulo has cleared two pivotal phase 3 trials in skin-lightening disorder vitiligo, allowing the company to start preparing for regulatory filings. The once-daily, oral TEC/JAK3 inhibitor has shown efficacy in active and stable nonsegmental vitiligo (NSV) – the most common form of vitiligo, accounting for about 90% of cases, where pale white patches appear symmetrically on both sides of the body and change unpredictably over time. In the TRANQUILLO and TRANQUILLO 2 trials, both doses of Litfulo (ritlecitinib) under test – 50 mg and 100 mg – delivered improvements over placebo on the facial and total body Vitiligo Area Scoring Index (VASI) at 52 weeks. TRANQUILLO enrolled patients aged 12 and over, while TRANQUILLO 2 was conducted in adults only. The product is the first steroid-free topical JAK inhibitor approved in the EU for atopic dermatitis, and has also been cleared for the disease in patients aged two and over in the US.