Baricitinib (Olumiant)
Baricitinib (Olumiant) is approved in at least one market for alopecia areata, developed by Eli Lilly.
The first JAK inhibitor approved for severe alopecia areata, in the United States and the European Union in June 2022.
- Developed by
- Eli Lilly
- Current phase
- Approved
- Mechanism
- JAK inhibitor
- Partners
- Incyte
- Indications
- Alopecia areata
- Also known as
- LY3009104, Olumiant
- Last public activity
- September 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
Its significance is chronological. Before June 2022 no systemic drug was approved for alopecia areata in the United States or the European Union, where treatment meant corticosteroids and off-label use; the FDA and the European Commission approved baricitinib that month, for adults, and the EU has since extended it to adolescents from 12. Every other JAK inhibitor in this register was approved after it. It treats the autoimmune form of hair loss, 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 UnionEMAApprovedOlumiant· prescription only
Severe alopecia areata, adults and adolescents 12 and older
Indication extended to severe alopecia areata during 2022 — CHMP positive opinion 20 May 2022, Commission decision later that year. No date is given here because the decision date is not traceable to a primary document; the EMA's own record shows 13 February 2017, which is the original authorisation for rheumatoid arthritis and not this indication. Extended to adolescents from 12 following a CHMP opinion in February 2026.
Regulator filing ↗ - United StatesFDAApprovedOlumiant· prescription only
Severe alopecia areata in adults
The first systemic treatment approved for alopecia areata anywhere.
Regulator filing ↗
Development history
- Phase 3Approved
First APPROVED trial on record: NCT06240351 — A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
ClinicalTrials.gov ↗ - Phase 2/3Phase 3
First Phase 3 trial on record: NCT03899259 — A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
ClinicalTrials.gov ↗ - Phase 2/3
First Phase 2/3 trial on record: NCT03570749 — A Study of Baricitinib (LY3009104) in Participants With Severe or Very 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.
Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
National Taiwan University Hospital · n=30 · January 2025
Baricitinib for Central Centrifugal Cicatricial Alopecia in Adults of African Descent
Raven Clinical Research · n=27 · October 2024
A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
University of Alabama at Birmingham · n=15 · April 2024
Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib
South Valley University · n=120 · September 2023
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Eli Lilly and Company · n=595 · February 2023
Assessment of Interleukin-15 and Interferon Gamma in Alopecia Areata Before and After Baricitinib.
Benha University · n=20 · January 2023
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
Eli Lilly and Company · n=606 · July 2019
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Eli Lilly and Company · n=784 · September 2018
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
- Olumiant — European public assessment report — Regulator filing
- Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata — Company release, February 2026
- OLUMIANT (baricitinib) tablets — prescribing information — Regulator filing, June 2022
- OLUMIANT (baricitinib) — FDA approval letter, alopecia areata indication — Regulator filing, June 2022
Related programmes
Other programmes in the register with the same mechanism: JAK inhibitor.
Cite this page
Hair Pipeline, "Baricitinib (Olumiant) — development record", hairpipeline.com/pipeline/baricitinib-aa