ritlecitinib
ritlecitinib: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.
ritlecitinib evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could ritlecitinib → PFE affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| PFIZER INC (PFE) | Approved |
Clinical Trials (4)
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA
Primary endpoint: Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, 12-WEEK PLACEBO-CONTROLLED STUDY WITH A 12-WEEK DOUBLE-BLIND EXTENSION PERIOD TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH CHRONIC SPONTANEOUS URTICARIA
Primary endpoint: Change from baseline in Urticaria Activity Score 7 (UAS7) at Week 12
Satisfaction and Treatment Experiences With RitlEcitiNib And Traditional Treatments for Severe Alopecia Areata Among Adults in the United States (SERENATA)
Primary endpoint: % of patients for whom their clinician was "satisfied" with current control of alopecia areata
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
Primary endpoint: US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52
FDA Decisions1 records
Frequently asked questions
Who is developing ritlecitinib?
ritlecitinib is being developed by PFIZER INC.
How many clinical trials involve ritlecitinib?
BioSniper tracks 4 clinical trials involving ritlecitinib.
What is ritlecitinib's latest FDA decision?
The most recent tracked FDA decision for ritlecitinib is Approval for 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, dated June 23, 2023.