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Encyclopedia · immunomodulator

Upadacitinib

A JAK1 pill already approved for other diseases that gave 45 to 55% of people with severe alopecia areata near-full scalp hair in two 2026 trials and is under regulatory review for hair.

Investigational, in trials Cost $$$ Safety: serious

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What it is

Upadacitinib is an oral JAK1-selective inhibitor from AbbVie, sold as Rinvoq and approved for several inflammatory diseases. For alopecia areata it is not approved as of 10 October 2026. AbbVie announced a US submission in April 2026 for adults and adolescents and said the European regulator is also reviewing it. We found no approval decision. It is not relevant to pattern hair loss.

What the studies show

  • Two replicate phase 3 trials (1,399 people aged 12 to 64 with at least 50% scalp loss) found at least 80% scalp hair at week 24 in 45.2% and 44.6% on 15 mg and 55.0% and 54.3% on 30 mg, versus 1.5% and 3.4% on placebo. The sponsor funded the trials (Mostaghimi 2026).
  • These are the highest rates reported in a pivotal alopecia areata programme, but comparisons with other JAK drugs are indirect and trial populations differ (Mostaghimi 2026).
  • The sponsor also reported complete regrowth at week 24 in about 14 to 22.5% on drug versus about 0 to 0.7% on placebo.

How it's used in studies

  • 15 mg or 30 mg once daily for 24 weeks placebo-controlled, then a 28-week extension (Mostaghimi 2026).

Side effects and safety

  • Common events in the programme were upper respiratory infection, acne, raised creatine phosphokinase and nasopharyngitis.
  • Rinvoq's class labelling for other uses warns of serious infections, cancer, major cardiovascular events, clots and gastrointestinal perforation.
  • The relapse-on-stopping seen with other JAK inhibitors is expected but not yet reported.

Bottom line

Upadacitinib has strong trial evidence of efficacy for severe alopecia areata but is still unapproved for hair, so watch for the regulators' decisions. Long-term safety at 30 mg is unknown. See JAK inhibitors and hair for the comparison. Discuss with a doctor.

Studies 1

Mostaghimi A et al. Upadacitinib for severe alopecia areata in adults and adolescents: two phase 3 UP-AA randomized clinical trials. JAMA Dermatol. 2026

Design
rct
People
1,399
Duration
24 weeks placebo-controlled, then 28-week extension
Who
people aged 12 to 64 with at least 50% scalp hair loss

Tested: upadacitinib 15 mg or 30 mg daily vs placebo

Result: At least 80% scalp hair at week 24 in 45.2% and 44.6% (15 mg), 55.0% and 54.3% (30 mg) vs 1.5% and 3.4% on placebo; sponsor-funded.

Read the study ↗