AbbVie (ABBV.US) has submitted an application for FDA approval for the use of upadacitinib in the treatment of alopecia.

On April 28th, AbbVie (ABBV.US) announced that it has submitted a new indication application to the US FDA for Upadacitinib, for the treatment of moderate to severe alopecia areata (AA) in adults and adolescents aged 12 and older. Upadacitinib is an orally administered, highly selective JAK1 inhibitor developed by AbbVie, currently being studied in various immune-mediated diseases. Based on enzyme and cell tests, Upadacitinib has shown greater inhibitory potency on JAK1 compared to JAK2, JAK3, and TYK2. Upadacitinib was first approved for marketing in the United States in 2019 and received approval for entry into China in February 2022. Global sales of the drug reached $8.304 billion in 2025, with a year-on-year growth of 39.1%. As of now, the drug has been approved for indications including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and giant cell arteritis. AbbVie stated that Upadacitinib is currently undergoing Phase III clinical trials for alopecia, hidradenitis suppurativa, giant cell arteritis, systemic lupus erythematosus, and vitiligo. The application for the indication of alopecia is based on positive results from two Phase III studies (UP-AA) with a mean baseline SALT score of 84 (equivalent to approximately 16% scalp hair coverage) in subjects.