Ritlecitinib
- Generic Name
- Ritlecitinib
- Brand Names
- Litfulo
- Drug Type
- Small Molecule
- Chemical Formula
- C15H19N5O
- CAS Number
- 1792180-81-4
- Unique Ingredient Identifier
- 2OYE00PC25
- Background
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)
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
- First Posted Date
- 2021-09-10
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 12
- Registration Number
- NCT05040295
- Locations
- 🇺🇸
New Haven Clinical Research Unit, New Haven, Connecticut, United States
PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS
- First Posted Date
- 2020-11-18
- Last Posted Date
- 2021-02-17
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 9
- Registration Number
- NCT04634565
- Locations
- 🇨🇳
Peking University Third Hospital, Beijing, Beijing, China
🇨🇳North District of Peking University Third Hospital, Beijing, China
PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
- First Posted Date
- 2020-08-18
- Last Posted Date
- 2024-06-18
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 71
- Registration Number
- NCT04517864
- Locations
- 🇺🇸
Stony Brook Dermatology, Stony Brook, New York, United States
🇨🇦Lynderm Research Inc., Markham, Ontario, Canada
🇺🇸Marvel Clinical Research 002, LLC, Huntington Beach, California, United States
TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2020-06-04
- Last Posted Date
- 2023-04-07
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 460
- Registration Number
- NCT04413617
- Locations
- 🇧🇬
Independent Medical Diagnostic Laboratory Mediscan EOOD, Plovdiv, Bulgaria
🇧🇬MHAT Plovdiv AD, Plovdiv, Bulgaria
🇧🇬DCC Sveti Georgi EOOD, Plovdiv, Bulgaria
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
- First Posted Date
- 2020-05-18
- Last Posted Date
- 2021-08-04
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 164
- Registration Number
- NCT04390776
- Locations
- 🇺🇸
Research Centers of America ( Hollywood ), Hollywood, Florida, United States
🇺🇸Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, United States
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
- First Posted Date
- 2020-04-21
- Last Posted Date
- 2020-09-03
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 10
- Registration Number
- NCT04355845
- Locations
- 🇺🇸
New Haven Clinical Research Unit, New Haven, Connecticut, United States
Study to Evaluate the Effect of Repeat-Dose Rifampin on the Pharmacokinetics (PK) of PF-06651600
- First Posted Date
- 2020-02-12
- Last Posted Date
- 2020-09-16
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 12
- Registration Number
- NCT04266509
- Locations
- 🇧🇪
Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
- First Posted Date
- 2019-09-17
- Last Posted Date
- 2020-02-06
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 12
- Registration Number
- NCT04092595
- Locations
- 🇧🇪
Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
A Renal Impairment Study for PF-06651600
- First Posted Date
- 2019-07-30
- Last Posted Date
- 2021-05-18
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 8
- Registration Number
- NCT04037865
- Locations
- 🇺🇸
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Miami, Florida, United States
🇺🇸University of Miami Division of Clinical Pharmacology, Miami, Florida, United States
🇺🇸Prism Clinical Research, LLC, Saint Paul, Minnesota, United States
Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids
- Conditions
- Healthy
- Interventions
- Drug: Ethinyl estradiol (EE) and levonorgestrel(LN)
- First Posted Date
- 2019-07-12
- Last Posted Date
- 2019-11-15
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 29
- Registration Number
- NCT04018274
- Locations
- 🇺🇸
Quotient Sciences Screening Office, Coral Gables, Florida, United States
🇺🇸Quotient Sciences, Miami, Miami, Florida, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.