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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

A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.

Recruiting
Conditions
Atopic Dermatitis
Eczema
First Posted Date
2023-01-19
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
183
Registration Number
NCT05689151
Locations
🇫🇷

CHU Amiens-Picardie - Site Nord, Amiens, Somme, France

🇫🇷

CHU Besancon - Hopital Jean Minjoz, Besancon, France

🇫🇷

Ch William Morey, Chalon Sur Saone, France

and more 7 locations

Janus Kinase Inhibition in Granuloma Annulare

Phase 2
Active, not recruiting
Conditions
Granuloma Annulare
Interventions
First Posted Date
2022-12-14
Last Posted Date
2025-03-04
Lead Sponsor
William Damsky
Target Recruit Count
10
Registration Number
NCT05650736
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

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

Phase 4
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2022-11-02
Last Posted Date
2025-03-28
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
24
Registration Number
NCT05602207
Locations
🇺🇸

Inno-6050 Site 22, Birmingham, Alabama, United States

🇺🇸

Inno-6050 Site 13, Fountain Valley, California, United States

🇺🇸

Inno-6050 Site 21, Miami Lakes, Florida, United States

and more 9 locations

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

Conditions
Severe Uncontrolled Atopic Dermatitis
First Posted Date
2022-07-20
Last Posted Date
2023-11-15
Lead Sponsor
Pfizer
Registration Number
NCT05466578

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

Recruiting
Conditions
Dermatitis, Atopic
First Posted Date
2022-05-25
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
1100
Registration Number
NCT05391061
Locations
🇰🇷

Pfizer Tower, Seoul, Korea, Republic of

A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.

Recruiting
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2022-05-24
Last Posted Date
2025-05-15
Lead Sponsor
Pfizer
Target Recruit Count
1200
Registration Number
NCT05387980
Locations
🇯🇵

Pfizer Local Country Office, Tokyo, Japan

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

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2022-05-17
Last Posted Date
2024-10-14
Lead Sponsor
Pfizer
Target Recruit Count
189
Registration Number
NCT05375929
Locations
🇮🇳

Nirmal Hospital Pvt Ltd., Surat, Gujarat, India

🇮🇳

All India Institute of Medical Sciences, New Delhi, Delhi, India

🇮🇳

S. P. Medical College & A. G. Hospitals, Bikaner, Rajasthan, India

and more 12 locations

JAK Inhibition in Food Allergy

Phase 1
Recruiting
Conditions
Food Allergy
Interventions
First Posted Date
2021-10-06
Last Posted Date
2024-11-11
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
40
Registration Number
NCT05069831
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

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

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2021-10-05
Last Posted Date
2024-05-31
Lead Sponsor
Pfizer
Target Recruit Count
26
Registration Number
NCT05067439
Locations
🇺🇸

Research Centers of America ( Hollywood ), Hollywood, Florida, United States

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

Phase 2
Completed
Conditions
Prurigo Nodularis
Pruritus
Chronic Pruritus
Chronic Prurigo
Skin Diseases
Interventions
First Posted Date
2021-09-09
Last Posted Date
2023-07-03
Lead Sponsor
Johns Hopkins University
Target Recruit Count
20
Registration Number
NCT05038982
Locations
🇺🇸

Johns Hopkins Outpatient Center, Baltimore, Maryland, United States

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