Opzelura

(Ritlecitinib)

ApprovedSmall molecule

Ritlecitinib is used to treat alopecia areata, a condition where the immune system attacks hair follicles causing hair loss, typically on the scalp, face, or body.[2] Opzelura is currently approved and in use across 13 indications[4].[1]

Opzelura is one of 324 small molecule programs targeting Alopecia. It is currently in Approved.

Indications

Total Trials

Active Trials

323

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AlopeciaApproved

Cicatricial AlopeciaApproved

Kidney DiseaseApproved

Liver DiseaseApproved

KeloidRecruiting

Rheumatoid ArthritisApproved

Crohn's DiseaseApproved

Ulcerative ColitisApproved

Alopecia AreataRecruiting

AsthmaApproved

AlopeciaApproved

Approved

Cicatricial AlopeciaApproved

Approved

Kidney DiseaseApproved

Approved

Liver DiseaseApproved

Approved

KeloidPhase 2

Recruiting

Rheumatoid ArthritisApproved

Approved

Crohn's DiseaseApproved

Approved

Ulcerative ColitisApproved

Approved

Alopecia AreataPhase 3

Recruiting

AsthmaApproved

Approved

Showing 10 of 13 indications

Competition

Competitive Landscape

176 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Opzelura

Pfizer

Approved

27 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Alopecia Areata

NCT07821216

Recruiting

Efficacy and Safety

NCT06573593

Q1 2027

Phase 2Active, not recruiting

Hidradenitis Suppurativa

NCT07228390

Phase 3Active, not recruiting

Severe Alopecia Areata

NCT07029711

Phase 3Active, not recruiting

Vitiligo

NCT06163326

Q2 2027

Phase 2Recruiting

Chronic Spontaneous Urticaria

NCT07219615

Clinical

Trials by Indication[1]

Alopecia Areata7 trials

A Study to Learn About the Medicine Called Ritlecitinib in Adults With Severe Alopecia Areata in Real-world Settings

Completed· Pfizer logo

Pfizer··NCT07200128·123 enrolled

A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

Completed· Pfizer logo

Pfizer·Phase 1·NCT05650333·15 enrolled

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

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07733765·336 enrolled

Show 4 more trials

A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06873945·674 enrolled

REAL-WORLD EFFECTIVENESS OF RITLECITINIB IN ALOPECIA AREATA PATIENTS IN THE US: A RETROSPECTIVE ANALYSIS USING EHR AND CLAIMS DATA

Active, not recruiting· Pfizer logo

Pfizer··NCT07821216·1 enrolled

PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.

Active, not recruiting· Pfizer logo

Pfizer··NCT06531109·450 enrolled

RETROSPECTIVE COHORT STUDY TO ASSESS UTILIZATION AND EFFECTIVENESS OF RITLECITINIB IN A REAL-WORLD POPULATION WITH SEVERE ALOPECIA AREATA IN THE UNITED STATES

Completed· Pfizer logo

Pfizer··NCT07226531·300 enrolled

Adult3 trials

A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT06172348·12 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT06369454·12 enrolled

A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05852340·12 enrolled

Vitiligo2 trials

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo

Completed· Pfizer logo

Pfizer·Phase 3·NCT05583526·607 enrolled

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT06163326·394 enrolled

Chronic Spontaneous Urticaria2 trials

Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria

Withdrawn·AAhuva D Cices·Phase 2·NCT06795373

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

Recruiting· Pfizer logo

Pfizer·Phase 2·NCT07219615·200 enrolled

Severe Alopecia Areata2 trials

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07029828·140 enrolled

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT07029711·208 enrolled

11 more indications

CTCL1 trial

Ritlecitinib in CTCL

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT05879458·7 enrolled

ESS1 trial

Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)

Available· Pfizer logo

Pfizer··NCT05522556

Tics1 trial

Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

Completed· Pfizer logo

Pfizer·Phase 1·NCT05097716·12 enrolled

Single Dose1 trial

A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT05040295·12 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06573593·150 enrolled

Celiac Disease1 trial

Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib to Prevent Gluten-induced Celiac Enteropathy and Symptoms in Celiac Disease Patients in Remission

Completed·MMassachusetts General Hospital·Phase 2·NCT05636293·62 enrolled

Non-segmental Vitiligo1 trial

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

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT06072183·1,571 enrolled

Hidradenitis Suppurativa1 trial

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF RITLECITINIB (PF-06651600) IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT07228390·128 enrolled

Diabetes Mellitus, Type 11 trial

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

Active, not recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT05743244·78 enrolled

Keloid1 trial

A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT06373458·30 enrolled

Unspecified1 trial

A Target Occupancy Study With Ritlecitinib.

Completed· Pfizer logo

Pfizer·Phase 1·NCT05128058·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 23, 2023

LITFULO

NDA NDA215830

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Ritlecitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Opzelura drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ritlecitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ritlecitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215830). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Opzelura. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase JAK3 Inhibitor; TEC Family Kinase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Dec 3, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12077533Dec 3, 2034

9617258Dec 3, 2034

12116368Oct 17, 2041

Opzelura

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Alopecia Areata7 trials

Adult3 trials

Vitiligo2 trials

Chronic Spontaneous Urticaria2 trials

Severe Alopecia Areata2 trials

CTCL1 trial

ESS1 trial

Tics1 trial

Single Dose1 trial

Efficacy and Safety1 trial

Celiac Disease1 trial

Non-segmental Vitiligo1 trial

Hidradenitis Suppurativa1 trial

Diabetes Mellitus, Type 11 trial

Keloid1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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