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Ritlecitinib (Litfulo)

An approved JAK inhibitor for severe alopecia areata — not for pattern baldness.

ApprovedOralJAK inhibitor
Developed by
Pfizer
Current phase
Approved

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

Indications
Alopecia areata
Also known as
PF-06651600, Litfulo
Last public activity
August 2026
Record confidence
High

Why it matters

Worth keeping in the register precisely because it is so often misread. JAK inhibitors work in alopecia areata, which is autoimmune. They do not treat androgenetic alopecia, which is the kind most people mean by 'going bald'.

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 UnionEMAApprovedLitfulo· prescription only

    Severe alopecia areata, adults and adolescents 12 and older

    Centrally authorised, so the authorisation covers France directly. Holder: Pfizer Europe MA EEIG.

    Regulator filing ↗
  • FranceEMAApprovedLitfulo· prescription only

    Pelade sévère, adulte et adolescent à partir de 12 ans

    Centrally authorised, so the EU decision covers France directly. Listed and marketed in France as LITFULO 50 mg. Confirmed against BDPM after checking that the authorisation date and the hair-loss indication are the same event — which they are here, because ritlecitinib was first authorised for this condition.

    Regulator filing ↗
  • United StatesFDAApprovedLitfulo· prescription only

    Severe alopecia areata, adults and adolescents 12 and older

    Regulator filing ↗

Development history

  1. Phase 2/3Phase 3

    First Phase 3 trial on record: NCT04006457 — Long-Term PF-06651600 for the Treatment of Alopecia Areata

    ClinicalTrials.gov ↗
  2. Phase 2Phase 2/3

    First Phase 2/3 trial on record: NCT03732807 — PF-06651600 for the Treatment of Alopecia Areata

    ClinicalTrials.gov ↗
  3. Phase 2

    First Phase 2 trial on record: NCT02974868 — Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With 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.

  • NCT05522556UnknownAVAILABLE

    Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)

    Pfizer

  • NCT07733765Phase 3NOT YET RECRUITING

    A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

    Pfizer · n=336 · July 2026

  • NCT07226531UnknownCOMPLETED

    Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

    Pfizer · n=300 · December 2025

  • NCT07029828Phase 3RECRUITING🇫🇷 With a site in France

    A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

    Pfizer · n=140 · September 2025

  • NCT07152119UnknownRECRUITING

    A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.

    Pfizer · n=3000 · August 2025

  • NCT07029711Phase 3ACTIVE NOT RECRUITING🇫🇷 With a site in France

    A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

    Pfizer · n=208 · July 2025

  • NCT06873945Phase 3RECRUITING

    A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

    Pfizer · n=1330 · April 2025

  • NCT07200128UnknownCOMPLETED

    A Study to Learn About the Medicine Called Ritlecitinib in Adults With Severe Alopecia Areata in Real-world Settings

    Pfizer · n=123 · February 2025

  • NCT06531109UnknownRECRUITING🇫🇷 With a site in France

    Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

    Pfizer · n=450 · August 2024

  • NCT06279221UnknownACTIVE NOT RECRUITING

    Litfulo Capsules Special Investigation

    Pfizer · n=487 · March 2024

  • NCT05650333Phase 1COMPLETED

    A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

    Pfizer · n=15 · March 2023

  • NCT05549934Phase 2COMPLETED

    Ritlecitinib for Cicatricial Alopecia

    Emma Guttman · n=50 · December 2022

  • NCT04517864Phase 2TERMINATED

    PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA

    Pfizer · n=71 · September 2020

  • NCT04006457Phase 3COMPLETED

    Long-Term PF-06651600 for the Treatment of Alopecia Areata

    Pfizer · n=1057 · July 2019

  • NCT03732807Phase 2/3COMPLETED

    PF-06651600 for the Treatment of Alopecia Areata

    Pfizer · n=718 · December 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