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Baricitinib (Olumiant)

The first systemic treatment ever approved for severe alopecia areata.

ApprovedOralJAK inhibitor
Developed by
Eli Lilly
Current phase
Approved

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

Partners
Incyte
Indications
Alopecia areata
Also known as
LY3009104, Olumiant
Last public activity
July 2026
Record confidence
High

Why it matters

Its significance is chronological. Before June 2022 there was no systemic drug approved anywhere for alopecia areata; every option was off-label. That approval is what made the current wave of JAK programmes in this register fundable. 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 from 12 years

    The 2017 date is the original EU authorisation, granted for other indications; severe alopecia areata was added by variation in 2022 and extended to adolescents afterwards. Centrally authorised, so it covers France directly. Holder: Eli Lilly Nederland B.V.

    Regulator filing ↗
  • United StatesFDAApprovedOlumiant· prescription only

    Severe alopecia areata in adults

    The first systemic treatment approved for alopecia areata anywhere.

    Regulator filing ↗

Development history

  1. 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 ↗
  2. 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 ↗
  3. 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.

  • NCT06797310Phase 2NOT YET RECRUITING

    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

  • NCT06240351ApprovedACTIVE NOT RECRUITING

    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

  • NCT06545110Phase 1ACTIVE NOT RECRUITING

    Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib

    South Valley University · n=120 · September 2023

  • NCT05723198Phase 3RECRUITING🇫🇷 With a site in France

    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

  • NCT07645430UnknownCOMPLETED

    Assessment of Interleukin-15 and Interferon Gamma in Alopecia Areata Before and After Baricitinib.

    Benha University · n=20 · January 2023

  • NCT03899259Phase 3COMPLETED

    A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

    Eli Lilly and Company · n=606 · July 2019

  • NCT03570749Phase 2/3COMPLETED

    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