AbbVie submitted an FDA application for upadacitinib in severe alopecia areata (adults and adolescents) in April 2026, based on the Phase 3 UP-AA program (two trials, 1,399 participants total); the EU had already approved it for severe alopecia.
- Lab
- Phase 1
- Phase 2
- Phase 3
- Approved
Approved (some countries)
How it works
Oral selective JAK1 inhibitor that suppresses the immune signalling (interferon-gamma/other cytokines) driving follicle attack in alopecia areata.
Results so far
Study 1: 45.2% (15 mg) and 55.0% (30 mg) of patients reached SALT<=20 at week 24 (vs placebo, exact placebo % not captured for Study 1). Study 2: 44.6% (15 mg) and 54.3% (30 mg) reached SALT<=20 at week 24 vs 3.4% placebo. Upadacitinib was the first JAK inhibitor reported to meet the ranked secondary endpoint of complete scalp regrowth (SALT=0) at week 24.
What's next
FDA decision pending as of October 2026 following the April 2026 submission; EU already approved.
In India
No India-specific approval or filing identified.
Sources
- Company announcement ↗ (accessed 2026-10-17)
- Company announcement ↗ (accessed 2026-10-17)
- Company announcement ↗ (accessed 2026-10-17)
- News report ↗ (accessed 2026-10-17)
What to do today: treatments in development aren't a reason to wait. Ask a dermatologist about the options that work now, such as minoxidil, or see alopecia areata treatments.
Discussion
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