Findings from two Phase 3 clinicals trial published in JAMA Dermatology found that upadacitinib (Rinvoq®), an oral Janus kinase (JAK) inhibitor, produced substantial hair regrowth in adults and adolescents with severe alopecia areata (AA). The findings add to growing evidence that JAK inhibitors can effectively treat this autoimmune disease and may expand future treatment options for people living with alopecia areata. The international studies enrolled nearly 1,400 adults and adolescents with severe alopecia areata. Participants were randomly assigned to receive either upadacitinib (15 mg or 30 mg once daily) or placebo. After 24 weeks of treatment: Approximately 55% of participants receiving the 30 mg dose achieved 80% or more scalp hair coverage (SALT ≤20), compared with 3.4% of those receiving placebo. Nearly 45% of participants receiving the 15 mg dose also reached this level of regrowth. Hair regrowth continued to improve through 52 weeks, with some participants achieving complete regrowth (SALT 0). Other important endpoints were achieved including improvement in eyebrows and eyelashes, and health-related quality of life. The medication is not currently approved by the U.S. Food and Drug Administration (FDA) to treat alopecia areata. However, it is already FDA-approved to treat several other immune-mediated conditions, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, psoriatic arthritis, and others. The study’s findings have already led to regulatory action outside the United States. In July 2026, the European Commission approved upadacitinib for the treatment of adults and adolescents (12 years and older) with severe alopecia areata, making it another approved treatment option in the European Union. Meanwhile, the medication is currently under FDA review for the treatment of severe alopecia areata in the United States. What This Means for Our Community These results represent another important step forward in expanding treatment options for people living with alopecia areata. While three oral JAK inhibitors are currently approved by the FDA for severe alopecia areata—Olumiant® (baricitinib), Litfulo® (ritlecitinib), and Leqselvi® (deuruxolitinib)—additional therapies could provide patients and healthcare providers with more choices to find the treatment that works best for each individual. NAAF will continue to keep our community updated on this and other treatment news.
