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 17 indications[4].[1]

Opzelura is one of 443 small molecule programs targeting Alopecia. It is currently in Approved.

Indications

Total Trials

Active Trials

442

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AlopeciaApproved

Cicatricial AlopeciaApproved

Kidney DiseaseApproved

Liver DiseaseApproved

KeloidActive, not recruiting

Rheumatoid ArthritisApproved

Crohn's DiseaseApproved

Ulcerative ColitisApproved

Alopecia AreataActive, not recruiting

Type 1 DiabetesActive, not recruiting

AlopeciaApproved

Approved

Cicatricial AlopeciaApproved

Approved

Kidney DiseaseApproved

Approved

Liver DiseaseApproved

Approved

KeloidPhase 2

Active, not recruiting

Rheumatoid ArthritisApproved

Approved

Crohn's DiseaseApproved

Approved

Ulcerative ColitisApproved

Approved

Alopecia AreataPhase 3

Active, not recruiting

Type 1 DiabetesPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Opzelura

Pfizer

Approved

25 2

Xolair

Roche

Preclinical

25 3

Singulair

AstraZeneca

Preclinical

17 4

Nucala

GGlaxo Dba Glaxosmithkline

Preclinical

35 5

Atrovent

Boehringer Ingelheim

Preclinical

5 6

Formoterol Fumarate

AstraZeneca

Preclinical

8 7

Symbicort

AstraZeneca

Preclinical

6 8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

1 9

Tylenol

KKenvue Brands

Preclinical

1 10

Blood Withdrawn

Emergent BioSolutions

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Efficacy and Safety

NCT06573593

Q1 2027

Phase 3Recruiting

Alopecia Areata

NCT06873945

Q2 2027

Phase 2Recruiting

Hidradenitis Suppurativa

NCT07228390

Phase 3Recruiting

Vitiligo

NCT06163326

Phase 2Recruiting

Chronic Spontaneous Urticaria

NCT07219615

Phase 3Recruiting

Alopecia Areata

NCT07029711

Clinical

Trials by Indication[1]

Alopecia Areata5 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 of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06873945·550 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

Show 2 more trials

A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07029828·140 enrolled

A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07029711·225 enrolled

Adult3 trials

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

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT06172348·12 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 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06163326·400 enrolled

Chronic Spontaneous Urticaria2 trials

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.

Recruiting· Pfizer logo

Pfizer·Phase 2·NCT07219615·200 enrolled

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

Withdrawn·AAhuva D Cices·Phase 2·NCT06795373

Keloid1 trial

Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

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

12 more indications

Type 1 Diabetes1 trial

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

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

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

ESS1 trial

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

Available· Pfizer logo

Pfizer··NCT05522556

Celiac Disease1 trial

Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05636293·40 enrolled

Outcome1 trial

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Recruiting· Pfizer logo

Pfizer··NCT06531109·850 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

Effectiveness1 trial

Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

Not yet recruiting· Pfizer logo

Pfizer··NCT07226531·300 enrolled

CTCL1 trial

Ritlecitinib in CTCL

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

Recruiting· Pfizer logo

Pfizer·Phase 2·NCT07228390·240 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

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 — 25 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 Areata5 trials

Adult3 trials

Vitiligo2 trials

Chronic Spontaneous Urticaria2 trials

Keloid1 trial

Type 1 Diabetes1 trial

Tics1 trial

ESS1 trial

Celiac Disease1 trial

Outcome1 trial

Single Dose1 trial

Efficacy and Safety1 trial

Effectiveness1 trial

CTCL1 trial

Hidradenitis Suppurativa1 trial

Non-segmental Vitiligo1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News