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Litfulo (Ritlecitinib Tosylate)

Pfizer · FDA-approved approved Small molecule Quality 63/100

Ritlecitinib irreversibly inhibits JAK3 and TEC kinase family by blocking ATP binding site.

LITFULO (ritlecitinib tosylate) is a JAK3/TEC kinase inhibitor approved for severe alopecia areata in patients 12 years and older. The drug demonstrates dose-proportional pharmacokinetics with rapid absorption (Tmax 1 hour), moderate protein binding (14%), and short half-life (1.3-2.3 hours), requiring metabolism through multiple pathways. Key risks include CYP3A and CYP1A2 inhibition requiring dose adjustments of concomitant substrates, and contraindication in patients with hypersensitivity or severe hepatic impairment. Not recommended for combination use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or potent immunosuppressants.

At a glance

Generic nameRitlecitinib Tosylate
SponsorPfizer
Drug classKinase inhibitor
TargetJanus kinase 3 (JAK3) and tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family
ModalitySmall molecule
Therapeutic areaImmunology
PhaseFDA-approved
First approval2023

Mechanism of action

Ritlecitinib is a kinase inhibitor that irreversibly inhibits JAK3 and the TEC kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine-induced STAT phosphorylation mediated by JAK3-dependent receptors and inhibits signaling of immune receptors dependent on TEC kinase family members. The relevance of inhibition of specific JAK or TEC family enzymes to therapeutic effectiveness is not currently known.

Approved indications

Common side effects

Drug interactions

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
FDA Orange BookPatents + exclusivity