Ritlecitinib
Janus-Associated Kinase (Jak) Inhibitors
Sold as Litfulo
- Drug class
- Janus-Associated Kinase (Jak) Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 3
- FDA reports (12 mo)
- 545
Overview
Plain-language summary, compiled from the cited regulatory records
Ritlecitinib is a kinase inhibitor [1]. It belongs to the drug class of Janus-Associated Kinase (Jak) Inhibitors [1].
Ritlecitinib is approved for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older [1]. It is marketed under the brand name Litfulo [1].
There were 545 adverse event reports for this active ingredient in the last 12 months [2]. The most frequent reactions reported include drug ineffectiveness, condition aggravation, off-label use, incomplete therapeutic product effect, and diarrhea [2]. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | March 20, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| EU European Union | EMA | 1 | March 3, 2025 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use :
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
( 1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).
How to take
CACanada· Health Canada
1 product
Uses
LITFULO (ritlecitinib) is indicated for: • the treatment of adults and adolescents 12 years and older with severe alopecia areata.
Limitations of Use:
Not recommended for use in combination with JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. 1 Pediatrics 12-17 years of age: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of LITFULO in pediatric patients 12-17 years of age has been established for severe alopecia areata.
Under 12 years of age:
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use in patients under 12 years of age. 2 Geriatrics There are limited data in patients ≥ 65 years of age. 4 Geriatrics.
EUEuropean Union· EMA
1 product
Uses
1).
How to take
Sources & citations
- [1]FDA DailyMed · 1882f799-61b0-48… · revised March 20, 2025 [PDF]
- [2]Health Canada (DPD) · 02543532 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/006025 · revised March 3, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.