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

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Phase 3
Completed
Conditions
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Dermatitis
Hypersensitivity
Genetic Diseases, Inborn
Skin Diseases, Genetic
Immune System Diseases
Interventions
Drug: Injectable Placebo
Drug: Oral Placebo
First Posted Date
2018-10-25
Last Posted Date
2021-01-19
Lead Sponsor
Pfizer
Target Recruit Count
838
Registration Number
NCT03720470
Locations
🇺🇸

Moonshine Research Center, Inc., Doral, Florida, United States

🇺🇸

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, North Carolina, United States

🇨🇦

Toronto Research Centre, Toronto, Ontario, Canada

and more 210 locations

A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

Phase 1
Completed
Conditions
Healthy Females
Interventions
First Posted Date
2018-09-07
Last Posted Date
2020-03-23
Lead Sponsor
Pfizer
Target Recruit Count
17
Registration Number
NCT03662516
Locations
🇺🇸

Pfizer New Haven Clinical Research Unit, New Haven, Connecticut, United States

A Renal Impairment Study for PF-04965842

Phase 1
Completed
Conditions
Renal Impairment
Interventions
First Posted Date
2018-09-06
Last Posted Date
2022-03-22
Lead Sponsor
Pfizer
Target Recruit Count
23
Registration Number
NCT03660241
Locations
🇺🇸

University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

University of Miami Division of Clinical Pharmacology, Miami, Florida, United States

and more 1 locations

A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers

Phase 1
Completed
Conditions
Phase 1
Interventions
First Posted Date
2018-08-27
Last Posted Date
2020-03-23
Lead Sponsor
Pfizer
Target Recruit Count
25
Registration Number
NCT03647670
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

Drug Interaction Study Evaluating the Effect of Rifampin on PK and Safety of PF 04965842.

Phase 1
Completed
Conditions
Healthy
Interventions
Other: rifampin
First Posted Date
2018-08-20
Last Posted Date
2020-02-28
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT03637790
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Phase 3
Completed
Conditions
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Interventions
First Posted Date
2018-08-13
Last Posted Date
2021-09-20
Lead Sponsor
Pfizer
Target Recruit Count
1235
Registration Number
NCT03627767
Locations
🇺🇸

Owensboro Dermatology Associates, Owensboro, Kentucky, United States

🇺🇸

MediSearch Clinical Trials, Saint Joseph, Missouri, United States

🇺🇸

The University of Texas Health Science Center Houston, Houston, Texas, United States

and more 232 locations

A Hepatic Impairment Study for PF-04965842.

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2018-08-13
Last Posted Date
2020-05-18
Lead Sponsor
Pfizer
Target Recruit Count
24
Registration Number
NCT03626415
Locations
🇺🇸

Prism Clinical Research, LLC, Saint Paul, Minnesota, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

Study Evaluating 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
2018-07-03
Last Posted Date
2020-04-21
Lead Sponsor
Pfizer
Target Recruit Count
391
Registration Number
NCT03575871
Locations
🇨🇦

Diex Recherche Sherbrooke Inc., Sherbrooke, Quebec, Canada

🇺🇸

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

🇺🇸

Center for Clinical Studies, LTD. LLP, Houston, Texas, United States

and more 110 locations

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

Phase 3
Active, not recruiting
Conditions
Dermatitis, Atopic
Interventions
First Posted Date
2018-02-06
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
3164
Registration Number
NCT03422822
Locations
🇺🇸

Tilda Research Inc., Irvine, California, United States

🇺🇸

Beach Allergy and Asthma Specialty Group, A Medical Corporation, Long Beach, California, United States

🇺🇸

Center for Clinical Studies, LTD.LLP, Webster, Texas, United States

and more 525 locations

A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2017-12-29
Last Posted Date
2019-10-14
Lead Sponsor
Pfizer
Target Recruit Count
36
Registration Number
NCT03386279
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

© Copyright 2025. All Rights Reserved by MedPath