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Upadacitinib (Rinvoq)

Approved in Europe for severe alopecia areata in July 2026, and still under FDA review.

ApprovedOralJAK inhibitor
Developed by
AbbVie
Current phase
Approved

Cleared for sale for a hair-loss indication in at least one market.

Indications
Alopecia areata
Also known as
ABT-494, Rinvoq
Last public activity
August 2026
Record confidence
High

Why it matters

The clearest example in this register of why approval is not one date. Europe approved it for adults and adolescents from 12; the United States is still reviewing the same application. Sponsor-reported Phase 3 results had 44.6% of patients on 15 mg and 54.3% on 30 mg reaching at least 80% scalp coverage at week 24, against 3.4% on placebo. As with every JAK inhibitor here, this treats alopecia areata — the autoimmune kind — and not pattern baldness.

Where it is approved

Marketing authorisation is granted country by country, for a specific indication. A drug approved for hair loss in one market may be approved only for something else — or not at all — in another.

  • European UnionEMAApprovedRinvoq· prescription only

    Severe alopecia areata, adults and adolescents from 12 years

    Centrally authorised, so it covers France directly.

    Company release ↗
  • United StatesFDANot approvedRinvoq

    Severe alopecia areata

    Under FDA review. The application was submitted in April 2026; upadacitinib is approved in the US for other conditions but not for alopecia areata.

    Company release ↗

Development history

  1. Phase 3

    First Phase 3 trial on record: NCT06012240 — A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

    ClinicalTrials.gov ↗

Registered trials

Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.

  • NCT04159597UnknownAVAILABLE

    Expanded Access to Upadacitinib

    AbbVie

  • NCT07772492Phase 3NOT YET RECRUITING🇫🇷 With a site in France

    A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata

    AbbVie · n=300 · August 2026

  • NCT07023302Phase 3ACTIVE NOT RECRUITING

    A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

    AbbVie · n=125 · June 2025

  • NCT06012240Phase 3RECRUITING🇫🇷 With a site in France

    A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

    AbbVie · n=1500 · October 2023

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

Sources