Pfizer (Pfizer (PFE)) just dropped some good news for people dealing with vitiligo. On Thursday, the company announced positive results from two Phase 3 trials of its drug LITFULO, which is already approved for severe alopecia areata. The drug, taken once daily, helped patients with nonsegmental vitiligo (NSV) — the most common form of the condition — see meaningful improvements in skin pigmentation, whether their disease was active or stable.
NSV is a chronic autoimmune disorder where the immune system goes after melanin-producing cells, leading to white patches on the skin and hair. It's not just cosmetic; it can have a real impact on quality of life. So a new oral treatment option would be a big deal.
Based on these results, Pfizer is getting ready to file for approval with regulators around the world. The goal is to get LITFULO approved as a new oral systemic therapy for adults with NSV.
The Trials: TRANQUILLO and TRANQUILLO 2
The Phase 3 program included two studies. TRANQUILLO enrolled patients aged 12 and older, while TRANQUILLO 2 was limited to adults. In both, patients took either 50 mg or 100 mg of LITFULO daily, and both doses beat placebo in a statistically meaningful way.
How did they measure improvement? Using the Vitiligo Area Scoring Index (VASI), which tracks how much skin is affected. By week 52, a significantly higher number of patients on LITFULO achieved at least a 75% improvement in facial vitiligo and a 50% improvement in total body vitiligo. That's real, visible progress.
Safety and What's Next
The safety profile in these vitiligo studies looked a lot like what's already known from LITFULO's use in alopecia areata. No new safety signals popped up, and the rate of side effects was similar across all groups. That's reassuring, since the FDA already approved LITFULO in 2023 for severe alopecia areata in adults and teens.
Pfizer isn't stopping here. The company plans to start a pivotal study for moderate alopecia areata later this year, and it will present more vitiligo data at a future medical conference.
On a different note, Pfizer also hit a snag last week: it paused distribution of its menopause cream Premarin in India due to unspecified supply chain issues. Premarin is a hormone therapy used for vaginal dryness and painful intercourse during menopause.
As for the stock, Pfizer shares were down 1.82% at $24.69 on Thursday. But the LITFULO news could be a bright spot for the company's pipeline.
