MedPath

Abrocitinib

Generic Name
Abrocitinib
Brand Names
Cibinqo
Drug Type
Small Molecule
Chemical Formula
C14H21N5O2S
CAS Number
1622902-68-4
Unique Ingredient Identifier
73SM5SF3OR
Background

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

Molecular Signatures in Inflammatory Skin Disease

First Posted Date
2017-11-30
Last Posted Date
2024-12-04
Lead Sponsor
Prof. Dr. Stephan Weidinger
Target Recruit Count
300
Registration Number
NCT03358693
Locations
🇩🇪

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany

Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Phase 3
Completed
Conditions
Dermatitis, Atopic
Interventions
First Posted Date
2017-11-21
Last Posted Date
2019-12-10
Lead Sponsor
Pfizer
Target Recruit Count
387
Registration Number
NCT03349060
Locations
🇨🇦

Diex Research Sherbrooke Inc., Sherbrooke, Quebec, Canada

🇺🇸

California Dermatology & Clinical Research Institute, Encinitas, California, United States

🇺🇸

Forward Clinical Trials, Inc., Tampa, Florida, United States

and more 84 locations

Absorption, Metabolism, Excretion and Absolute Bioavailability

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Absolute Bioavailability
First Posted Date
2017-08-15
Last Posted Date
2017-12-21
Lead Sponsor
Pfizer
Target Recruit Count
6
Registration Number
NCT03250039
Locations
🇳🇱

PRA Health Sciences, Groningen, Netherlands

Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Placebo
First Posted Date
2016-05-23
Last Posted Date
2019-05-02
Lead Sponsor
Pfizer
Target Recruit Count
269
Registration Number
NCT02780167
Locations
🇺🇸

The Dermatology Group, P.C, Verona, New Jersey, United States

🇺🇸

Dawes Fretzin Dermatology Group, LLC, Indianapolis, Indiana, United States

🇺🇸

Clinical Research Consortium, Las Vegas, Nevada, United States

and more 61 locations

Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

Phase 2
Terminated
Conditions
Plaque Psoriasis
Interventions
Other: Placebo
First Posted Date
2014-07-28
Last Posted Date
2016-10-05
Lead Sponsor
Pfizer
Target Recruit Count
59
Registration Number
NCT02201524
Locations
🇺🇸

Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA, Rogers, Arkansas, United States

🇺🇸

California Dermatology & Clinical Research Institute, Encinitas, California, United States

🇺🇸

Clinical Science Institute, Santa Monica, California, United States

and more 42 locations

AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: PF- 04965842
First Posted Date
2014-06-13
Last Posted Date
2014-08-18
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT02163161
Locations
🇧🇪

Pfizer Investigational Site, Brussels, Belgium

First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2013-04-18
Last Posted Date
2014-06-20
Lead Sponsor
Pfizer
Target Recruit Count
79
Registration Number
NCT01835197
Locations
🇺🇸

Pfizer Investigational Site, New Haven, Connecticut, United States

© Copyright 2025. All Rights Reserved by MedPath