CIBINQO (abrocitinib)
CIBINQO is indicated for the treatment of Atopic Dermatitis.
How CIBINQO Works
Abrocitinib is a Janus kinase (JAK) inhibitor that reversibly inhibits the JAK1 enzyme by blocking its adenosine triphosphate (ATP) binding site. In vitro, the drug and its active metabolites demonstrate selectivity for JAK1 over JAK2, JAK3, and TYK2. However, the clinical relevance of inhibiting specific JAK enzymes to the drug's therapeutic effectiveness is not currently known.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-01-14
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET
CIBINQO Approval History
What CIBINQO Treats
1 indicationsCIBINQO is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
CIBINQO Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. • Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. Test...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. • Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. ( 5.1 ) • Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients. ( 5.2 ) • Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) • MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) • Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 ) Serious Infections Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection. Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: • Active tuberculosis, which may present with pulmonary or e
CIBINQO Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
CIBINQO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CIBINQO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CIBINQO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CIBINQO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06807268 | B7451023 2023-509121-51-00 | Ph 3 | recruiting | A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema |
| NCT06597396 CLEAR-LC | 2024P000700 | Ph 2 | active not recruiting | Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID |
| NCT06807281 | B7451031 2023-509124-18-00 | Ph 3 | recruiting | A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema |
| NCT07242638 | STUDY-25-00773 1R61AR084210 | Ph 2 | recruiting | Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05069831 | GCO 21-0781 | Ph 1 | completed | JAK Inhibition in Food Allergy |
| NCT05602207 | Inno-6050 | Ph 4 | completed | Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab |
| NCT05067439 results posted | B7451092 | Ph 1 | completed | A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants |
| NCT05038982 results posted | IRB00262268 | Ph 2 | completed | Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CIBINQO FDA Label Details
Indications & Usage
FDA Label (PDF)CIBINQO is indicated for the treatment of Atopic Dermatitis.
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. • Increased risk of seri...
CIBINQO Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CIBINQO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 27 active patents
Trial Analysis
- • 9 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment