Ritlecitinib

Overview

Ritlecitinib (PF-06651600) is a highly selective inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family. In June 2023, it was approved by the FDA for the treatment of severe alopecia areata in adults and adolescents 12 years and older. It was further approved by the EMA in September 2023. Ritlecitinib is administered orally and is the first member of its class. Ritlecitinib binds covalently to Cys-909 of JAK3, a site where other JAK isoforms have a serine residue. This makes ritlecitinib a highly selective and irreversible JAK3 inhibitor. Other kinases have a cysteine at a position equivalent to Cys-909 in JAK3, and several of them belong to the TEC kinase family. It has been suggested that the dual activity of ritlecitinib toward JAK3 and the TEC kinase family block cytokine signaling as well as the cytolytic activity of T cells, both implicated in the pathogenesis of alopecia areata.

Indication

Ritlecitinib is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Associated Conditions

Severe Alopecia Areata (AA)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata	2025/03/13	NCT06873945	Phase 3	Recruiting	Pfizer
Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria	2025/01/28	NCT06795373	Phase 2	Recruiting	Ahuva D Cices
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study	2024/08/27	NCT06573593	N/A	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib	2024/07/31	NCT06531109	N/A	Recruiting	Pfizer
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy	2024/04/18	NCT06373458	Phase 2	Recruiting	Icahn School of Medicine at Mount Sinai
A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food	2024/04/17	NCT06369454	Phase 1	Completed	Pfizer
Litfulo Capsules Special Investigation	2024/02/28	NCT06279221	N/A	Active, not recruiting	Pfizer
A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults	2023/12/15	NCT06172348	Phase 1	Completed	Pfizer
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo	2023/12/08	NCT06163326	Phase 3	Recruiting	Pfizer
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2	2023/10/10	NCT06072183	Phase 3	Active, not recruiting	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Litfulo	U.S. Pharmaceuticals	63539-334	ORAL	50 mg in 1 1	6/23/2023
Litfulo	Pfizer Laboratories Div Pfizer Inc	0069-0334	ORAL	50 mg in 1 1	6/23/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LITFULO CAPSULE 50MG	Pfizer Manufacturing Deutschland GmbH	SIN17041P	CAPSULE	50mg	7/5/2024

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ritlecitinib Tosylate Capsules	PFIZER INC.	国药准字HJ20230118	化学药品	胶囊剂	10/18/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LITFULO ritlecitinib (as tosylate) 50 mg hard capsule bottle	427294	Pfizer Australia Pty Ltd	Medicine	A	7/9/2024
LITFULO ritlecitinib (as tosylate) 50 mg hard capsule blister pack	427296	Pfizer Australia Pty Ltd	Medicine	A	7/9/2024

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