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Cibinqo

(Abrocitinib)

ApprovedSmall molecule

Abrocitinib is used to treat moderate to severe atopic dermatitis (eczema), a skin condition that causes itching, inflammation, and irritation. It helps reduce these symptoms by calming down the immune system's overactive response in the skin.[2] Cibinqo is currently approved and in use across 17 indications[4].[1]

Cibinqo is one of 328 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

17

Indications

27

Total Trials

15

Active Trials

327

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusApproved

Lupus ErythematosusApproved

Atopic EczemaActive, not recruiting

Toxic Epidermal NecrolysisActive, not recruiting

Granuloma AnnulareActive, not recruiting

SarcoidosisActive, not recruiting

Kidney DiseaseApproved

Eczematoid DermatitisActive, not recruiting

Food AllergyActive, not recruiting

Liver DiseaseApproved

Systemic Lupus ErythematosusApproved

Approved

Lupus ErythematosusApproved

Approved

Atopic EczemaApproved

Active, not recruiting

Toxic Epidermal NecrolysisPhase 1

Active, not recruiting

Granuloma AnnularePhase 2

Active, not recruiting

SarcoidosisPhase 2

Active, not recruiting

Kidney DiseaseApproved

Approved

Eczematoid DermatitisApproved

Active, not recruiting

Food AllergyPhase 1

Active, not recruiting

Liver DiseaseApproved

Approved

Showing 10 of 16 indications

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Cibinqo

Bimzelx

Humira

Ilumya

Sun Pharmaceutical Industries, Inc.

Raptiva

Remicade

OOrganon and Co

Siliq

BBausch Health Americas, Inc.

Victoza

Lovenox

Olux

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Toxic Epidermal Necrolysis

NCT06119490

Atopic Dermatitis

NCT06899204

Phase 2Active, not recruiting

Fatigue

NCT06597396

Q4 2026

Efficacy and Safety

NCT06573593

Q2 2027

Phase 3Recruiting

Children

NCT06807268

Phase 2Active, not recruiting

Type 1 Diabetes

NCT05743244

Clinical

Trials by Indication[1]

Atopic Dermatitis11 trials

A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis

Recruiting· Pfizer logo

Pfizer··NCT05391061·1,100 enrolled

Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab

Completed·IInnovaderm Research Inc.·Phase 4·NCT05602207·24 enrolled

Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

Recruiting· Pfizer logo

Pfizer··NCT06899204·150 enrolled

Show 8 more trials

Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT07242638·56 enrolled

Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

No longer available· Pfizer logo

Pfizer··NCT04564755

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Not yet recruiting·CCaja Costarricense de Seguro Social··NCT07448363·50 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Completed· Pfizer logo

Pfizer·Phase 3·NCT04345367·727 enrolled

A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India

Completed· Pfizer logo

Pfizer·Phase 3·NCT05375929·200 enrolled

Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT03422822·3,166 enrolled

Treating Atopic Dermatitis With Abrocitinib and Its Impact in Real Life: An Observational Cohort Study To Describe the Effectiveness of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis.

Recruiting· Pfizer logo

Pfizer··NCT05689151·183 enrolled

Children2 trials

A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06807268·150 enrolled

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06807281·500 enrolled

Caffeine1 trial

A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05067439·26 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

Recruiting·PProf. Dr. Stephan Weidinger··NCT03358693·300 enrolled

Toxic Epidermal Necrolysis1 trial

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Recruiting·PPeng Zhang·Phase 1·NCT06119490·30 enrolled

11 more indications

Fatigue1 trial

Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID

Active, not recruiting·—·Phase 2·NCT06597396·46 enrolled

Pregnant Women and Their Offspring1 trial

A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring

Recruiting· Pfizer logo

Pfizer··NCT05721937·400 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

Prurigo Nodularis1 trial

Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin

Completed·JJohns Hopkins University·Phase 2·NCT05038982·20 enrolled

ESS1 trial

Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)

Available· Pfizer logo

Pfizer··NCT05466578

Food Allergy1 trial

JAK Inhibition in Food Allergy

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT05069831·71 enrolled

Oral1 trial

A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.

Completed· Pfizer logo

Pfizer·Phase 1·NCT04903093·19 enrolled

Chronic Hand Eczema1 trial

Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Completed·IInnovaderm Research Inc.·Phase 2·NCT06283550·82 enrolled

Sarcoidosis1 trial

Janus Kinase Inhibition in Sarcoidosis

Completed·YYale University·Phase 2·NCT05696795·10 enrolled

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

Granuloma Annulare1 trial

Janus Kinase Inhibition in Granuloma Annulare

Active, not recruiting·WWilliam Damsky·Phase 2·NCT05650736·10 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 14, 2022

CIBINQO

NDA NDA213871

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Abrocitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cibinqo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Abrocitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Abrocitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213871). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cibinqo. 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 JAK1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Feb 19, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9549929Feb 19, 2034

9545405Feb 19, 2034

9035074Jan 14, 2036

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