Ritlecitinib: First Approval

August 2023 in “ Drugs ”

Hannah A. Blair

ritlecitinib alopecia areata oral kinase inhibitor LITFULO

TLDR Ritlecitinib is approved in the USA and Japan for treating severe hair loss in people aged 12 and older.

Ritlecitinib (LITFULO™), an oral kinase inhibitor developed by Pfizer, has been approved in the USA and Japan for treating severe alopecia areata in individuals aged 12 and older. The approval in the USA occurred on 23 June 2023, while Japan approved it on 26 June 2023 for intractable cases with widespread hair loss. The drug has also received a positive opinion in the EU and is under regulatory review in the UK and China. This marks a significant milestone in the development of ritlecitinib for severe alopecia areata.

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Research cited in this study

4 / 4 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”

Ritlecitinib effectively treats alopecia areata and is safe for long-term use in people 12 and older.

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”

Continuous treatment with ritlecitinib and brepocitinib is needed to maintain hair regrowth in alopecia areata.

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”

Ritlecitinib and brepocitinib effectively regrow hair in alopecia areata patients.