Ritlecitinib: First Approval

August 2023 in “ Drugs ”

Hannah A. Blair

ritlecitinib alopecia areata oral kinase inhibitor LITFULO

Studysummary This article describes the development milestones and recent approvals of ritlecitinib for treating severe alopecia areata, with approvals in the USA and Japan and ongoing regulatory reviews in other regions.

Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer

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Research cited in this study

5 / 5 results

research Efficacy and Safety of the Oral Janus Kinase 3/Tyrosine Kinase Inhibitor Ritlecitinib Over 24 Months: Integrated Analysis of the ALLEGRO Phase IIb/III and Long-Term Phase III Clinical Studies in Alopecia Areata

23 citations , October 2024 in “British Journal of Dermatology”

In this study, ritlecitinib showed sustained effectiveness and a favorable safety profile in treating alopecia areata in patients aged 12 and older over 24 months, with improvements observed in hair and eyebrow regrowth and patient satisfaction.

research Integrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program

4 citations , November 2023 in “SKIN The Journal of Cutaneous Medicine”

In this study, ritlecitinib, an oral JAK3/TEC inhibitor, was evaluated for safety in patients aged 12 and older with alopecia areata across four clinical trials up to 36 months, showing a safety profile with reported adverse events and lab abnormalities summarized per dosing groups.

research Efficacy and Safety of Ritlecitinib in Adults and Adolescents With Alopecia Areata: A Randomised, Double-Blind, Multicentre, Phase 2b–3 Trial

227 citations , April 2023 in “The Lancet”

Ritlecitinib effectively treats alopecia areata and is well-tolerated.

research Maintenance, Withdrawal, and Re-Treatment with Ritlecitinib and Brepocitinib in Patients with Alopecia Areata in a Single-Blind Extension of a Phase 2a Randomized Clinical Trial

20 citations , December 2021 in “Journal of the American Academy of Dermatology”

This study found that the oral JAK inhibitors ritlecitinib and brepocitinib were effective in maintaining hair regrowth in alopecia areata with continuous use, though efficacy decreased after withdrawal.

research A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results

138 citations , March 2021 in “Journal of the American Academy of Dermatology”

This study found that treatment with ritlecitinib or brepocitinib was effective in improving scalp hair loss for patients with alopecia areata over 24 weeks compared to placebo.