Severe alopecia areata—an autoimmune disorder that causes significant hair loss on the scalp and body—is notoriously hard to treat, and options have stayed limited for years. That’s starting to change, at least in Europe, where a once-daily pill just cleared its biggest hurdle yet for regrowing hair in adults and adolescents with severe cases.
As reported by Dermatology Times, the European Commission approved upadacitinib, sold as Rinvoq, for adults and adolescents 12 and older with severe alopecia areata, at 15 mg and 30 mg once-daily doses. One important detail: the approval is EU-specific. Upadacitinib is not yet approved in the US, where the FDA has been reviewing AbbVie’s application since April 2026.
What the Research Showed
The approval rests on two large clinical trials that enrolled nearly 1,400 people with severe alopecia areata. By week 24, about 45 percent of patients on the 15 mg dose and 55 percent on the 30 mg dose reached at least 80 percent scalp coverage, compared with only a small fraction of those on placebo. Some patients saw complete scalp regrowth, along with improvement in their eyebrows and eyelashes.
“Alopecia areata is a complex condition to treat often due to its unpredictable disease course and prognosis,” said Nice, France, dermatologist Thierry Passeron, MD, PhD, professor and chair of the department of dermatology at the Université Côte d’Azur. “The UP-AA results based on stringent endpoints demonstrated clinically meaningful scalp hair regrowth and improvements in eyebrows and eyelashes in 24 weeks, supporting RINVOQ as an important new treatment option for severe alopecia areata patients in Europe.”
Where Things Stand in the US
If the FDA eventually clears upadacitinib for severe alopecia areata, it would become the fourth JAK inhibitor approved in the US for the condition, joining baricitinib, sold as Olumiant, ritlecitinib, sold as Litfulo and deuruxolitinib, sold as Leqselvi. Like those medications, upadacitinib carries boxed warnings covering infection, cancer, cardiovascular events, blood clots and mortality risk, and it is not the right fit for everyone. The most commonly reported side effects in the trials were acne, nasopharyngitis and upper respiratory infections.
For now, US patients and dermatologists dealing with severe hair loss still have three approved options to consider while upadacitinib’s US availability awaits the FDA’s decision. Living with alopecia areata can take a real toll beyond the physical, affecting confidence and daily life, and having more tools in the pipeline, even ones still working through review, is meaningful. If you are noticing unexplained patchy hair loss, talk to a board-certified dermatologist about what treatment path, current or upcoming, might be right for you.
