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ritlecitinib

Generic: RITLECITINIB TOSYLATE·Brand: LITFULO, Litfulo

ritlecitinib: sourced relationships with 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

Source-backed records connect ritlecitinib to PFE; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could ritlecitinib → PFE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
PFIZER INC (PFE)
Reported 2023-06-23 · Current development: unknownSource
Approved
Clinical Trial Registry Records (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

NCT07733765Registry updated 2026-07-29·Phase 3·PFE
Not yet recruiting

Primary endpoint: Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo

InterventionalRandomizedquadruple336 targetStarted 2026-07Completion 2028-044 sites · United StatesPfizer

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

NCT07219615Registry updated 2026-06-17·Phase 2·PFE
Recruiting

Primary endpoint: Change from baseline in Urticaria Activity Score 7 (UAS7) at Week 12

InterventionalRandomizedquadruple200 targetStarted 2025-10Completion 2027-0450 sites · Bulgaria, Canada, China, Germany…Pfizer

Satisfaction and Treatment Experiences With RitlEcitiNib And Traditional Treatments for Severe Alopecia Areata Among Adults in the United States (SERENATA)

NCT07200128Registry updated 2026-06-10·PFE
Completed

Primary endpoint: % of patients for whom their clinician was "satisfied" with current control of alopecia areata

Observational123 enrolledStarted 2025-02Completion 2025-051 site · United StatesPfizer

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

NCT06072183Registry updated 2026-06-24·Phase 3·PFE
Active, not recruiting

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

InterventionalRandomizedquadruple1,571 targetStarted 2023-11Completion 2027-0750 sites · United StatesPfizer
FDA Decisions1 records
Approval(PFE)FDA ↗
NDA215830Type 1 - New Molecular EntityStandardOralCapsule

Frequently asked questions

Which companies have sourced relationships with ritlecitinib?

ritlecitinib has dated SEC/FDA relationship records for 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, dated June 23, 2023.