Upadacitinib (Rinvoq)
Upadacitinib (Rinvoq) is approved in at least one market for alopecia areata, developed by AbbVie.
Approved in the EU for severe alopecia areata in July 2026, and still under FDA review.
- Developed by
- AbbVie
- Current phase
- Approved
- Mechanism
- JAK inhibitor
- Indications
- Alopecia areata
- Also known as
- ABT-494, Rinvoq
- Last public activity
- October 2026
- Copy last reviewed
- September 2026
- Record confidence
- High
Cleared for sale for a hair-loss indication in at least one market.
Calms the immune attack on the follicle by blocking JAK signalling - the class that transformed alopecia areata.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
Why it matters
The clearest example in this register of why approval is not one date. The European Commission approved it for adults and adolescents from 12; the FDA is still reviewing the same data. In the two Phase 3 studies, by AbbVie's account, 44.6% and 45.2% of patients on 15 mg and 54.3% and 55.0% on 30 mg reached at least 80% scalp coverage at week 24, against 3.4% and 1.5% 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
- Phase 3Approved
Approved by the European Commission for severe alopecia areata in adults and adolescents from 12. Still under FDA review in the US.
Company release ↗ - 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.
Expanded Access to Upadacitinib
AbbVie
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
AbbVie · n=300 · August 2026
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
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
- Rinvoq — European public assessment report — Regulator filing
- European Commission approves RINVOQ (upadacitinib) for severe alopecia areata — Company release, July 2026
- AbbVie submits FDA application for upadacitinib in severe alopecia areata — Company release, April 2026
- Positive topline results from the Phase 3 UP-AA trial — Company release, July 2025
Related programmes
Other programmes in the register with the same mechanism: JAK inhibitor.
Cite this page
Hair Pipeline, "Upadacitinib (Rinvoq) — development record", hairpipeline.com/pipeline/upadacitinib-aga