For Most Children With Alopecia Areata, No Systemic Drug Is Approved Yet

A retrospective cohort study titled "Predictors of systemic treatment response in pediatric alopecia areata" went online August 8 in the Journal of the American Academy of Dermatology, credited to researchers at the University of Toronto's Temerty Faculty of Medicine and the Hospital for Sick Children, with a coauthor from the Pediatric Dermatology Research Alliance in Portland, Oregon. It is filed as a short communication and still listed as ahead of print. As of this week, PubMed's record carries the title, the author list, four keywords (alopecia areata, biologics, pediatrics, small molecules), and no abstract. There is nothing yet to report about what the study found.

What is checkable now is the shelf of medicine those keywords point toward. In the United States, exactly one systemic drug carries FDA approval for treating alopecia areata in anyone under eighteen: ritlecitinib, sold as Litfulo, approved June 23, 2023 for patients twelve and older with severe disease. Below age twelve, no systemic alopecia areata treatment carries FDA approval, for any drug, at any dose.

Two other pills, adults only

The two other systemic drugs approved for alopecia areata in the US, baricitinib (Olumiant, approved June 13, 2022) and deuruxolitinib (Leqselvi, approved July 2024), remain limited to adults eighteen and older; neither has a pediatric indication. Europe is moving, unevenly, in a different direction. In February 2026, the European Medicines Agency's drug committee recommended extending baricitinib to adolescents twelve to under eighteen, based on a placebo-controlled pediatric trial. That recommendation still needed European Commission sign-off as of the announcement. The US has not followed.

The one pathway that could lower the US age line further is already running. Pfizer's Phase 3 trial of ritlecitinib in children six to under twelve with severe alopecia areata began enrolling in July 2025, has since stopped recruiting, and by its own registration is not expected to reach primary completion before December 2026, with full completion estimated for January 2027. Until that data reads out, children under twelve have no on-label systemic option at all.

What the study will have to sit inside

None of this says what the Toronto team's chart review found, and it would be a mistake to guess. But it frames the terrain their patients were treated in. For the youngest children in a cohort like this, response to systemic treatment likely describes a prescription made without a matching FDA label, not a documented trial. That is a reasonable, specific question to bring to a pediatric dermatologist: whether a proposed treatment carries approval for a child's exact age, and what prescribing it off label means for how closely it gets watched.

Sources: FDA label, Litfulo (ritlecitinib) · ClinicalTrials.gov, NCT07029711