Overview
Abrocitinib is an oral small-molecule inhibitor of Janus kinase 1 (JAK1). Janus kinases are intracellular enzymes involved in transduction pathways that regulate hematopoiesis and immune cell function. The Janus kinase (JAK)–signal transducer and activator of transcription (STAT) signalling pathway plays a central role in the pathogenesis of a variety of autoimmune and inflammatory diseases, including atopic dermatitis, a chronic inflammatory skin disease with complex pathogenesis. Atopic dermatitis is characterized by epidermal hyperplasia, skin barrier dysfunction, and the aberrant activation of immune cells. Patients with moderate-to-severe atopic dermatitis report reduced quality of life and often face limited treatment options. JAK inhibitors recently attracted more attention as potential treatments for inflammatory disorders, as JAK inhibition is associated with rapid and sustained anti-inflammatory efects. Abrocitinib was approved by the European Commission on December 10, 2021, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. On January 14, 2022, the FDA approved abrocitinib for the treatment of refractory, moderate-to-severe AD in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Health Canada also approved the use of abrocitinib in pediatric patients 12 years and older.
Indication
Abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. In the US, it is indicated to treat refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when the use of those therapies is inadvisable. Abrocitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Associated Conditions
- Severe Atopic Dermatitis
- Moderate Atopic dermatitis
- Moderate, refractory Atopic dermatitis
- Refractory, severe Atopic Dermatitis
Research Report
Comprehensive Monograph on Abrocitinib (Cibinqo®)
Executive Summary
Abrocitinib, marketed under the brand name Cibinqo®, is an oral, small-molecule, selective Janus Kinase 1 (JAK1) inhibitor developed by Pfizer. It represents a significant advancement in the systemic treatment of atopic dermatitis (AD), a chronic inflammatory skin disease. This report provides a comprehensive analysis of abrocitinib, encompassing its chemical synthesis, pharmacological profile, clinical evidence, regulatory status, and strategic position in the therapeutic landscape.
The primary approved indication for abrocitinib is for the treatment of moderate-to-severe atopic dermatitis in adolescents (aged 12 and older) and adults. Regulatory approvals vary slightly by region, with the U.S. Food and Drug Administration (FDA) specifying its use in patients with refractory disease who have failed other systemic therapies, while the European Medicines Agency (EMA) approves it for patients who are candidates for systemic therapy. Abrocitinib is administered as a once-daily oral tablet.
Pharmacologically, abrocitinib functions by selectively inhibiting JAK1, thereby disrupting the signaling cascades of key pro-inflammatory cytokines implicated in AD pathogenesis, including Interleukin-4 (IL-4), IL-13, and IL-31. Its selectivity for JAK1 over other JAK family members, particularly JAK3, is a key feature of its design, intended to optimize its immunomodulatory effects while potentially mitigating certain side effects associated with less selective JAK inhibition. The drug is rapidly absorbed and extensively metabolized by hepatic CYP2C19 and CYP2C9 enzymes into two active metabolites, which, together with the parent compound, constitute the total "active moiety" responsible for the therapeutic effect.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/27 | N/A | Not yet recruiting | |||
2025/02/04 | Phase 3 | Recruiting | |||
2025/02/04 | Phase 3 | Not yet recruiting | |||
2024/09/19 | Phase 2 | Recruiting | |||
2024/08/27 | N/A | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/02/28 | Phase 2 | Active, not recruiting | |||
2023/11/07 | Early Phase 1 | Recruiting | Peng Zhang | ||
2023/02/24 | Phase 2 | Recruiting | |||
2023/02/10 | N/A | Recruiting | |||
2023/01/25 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-436 | ORAL | 200 mg in 1 1 | 12/19/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0235 | ORAL | 50 mg in 1 1 | 2/13/2023 | |
| U.S. Pharmaceuticals | 63539-236 | ORAL | 50 mg in 1 1 | 12/19/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0335 | ORAL | 100 mg in 1 1 | 2/13/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0435 | ORAL | 200 mg in 1 1 | 2/13/2023 | |
| U.S. Pharmaceuticals | 63539-336 | ORAL | 100 mg in 1 1 | 12/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/9/2021 | ||
Authorised | 12/9/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CIBINQO Film-Coated Tablet 200 mg | SIN16414P | TABLET, FILM COATED | 200.00 mg | 1/5/2022 | |
| CIBINQO Film-Coated Tablet 100 mg | SIN16413P | TABLET, FILM COATED | 100.00 mg | 1/5/2022 | |
| CIBINQO Film-Coated Tablet 50 mg | SIN16412P | TABLET, FILM COATED | 50.00 mg | 1/5/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CIBINQO abrocitinib 200 mg tablet blister pack | 346351 | Medicine | A | 4/16/2024 | |
| CIBINQO abrocitinib 50 mg tablet blister pack | 346349 | Medicine | A | 4/16/2024 | |
| CIBINQO abrocitinib 100 mg tablet blister pack | 346350 | Medicine | A | 4/16/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CIBINQO 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211593014 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| CIBINQO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211593009 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| CIBINQO 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211593004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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