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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

Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

Not yet recruiting
Conditions
Atopic Dermatitis
Atopic Dermatitis, Unspecified
Dermatitis, Atopic
Interventions
First Posted Date
2025-03-27
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
150
Registration Number
NCT06899204

A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

Phase 3
Not yet recruiting
Conditions
Eczema
Interventions
Other: Placebo
First Posted Date
2025-02-04
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
150
Registration Number
NCT06807268

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

Phase 3
Not yet recruiting
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2025-02-04
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
500
Registration Number
NCT06807281

Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID

Phase 2
Recruiting
Conditions
Post-COVID Condition
Fatigue Symptom
Interventions
Drug: Placebo
First Posted Date
2024-09-19
Last Posted Date
2025-02-05
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
90
Registration Number
NCT06597396
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Recruiting
Conditions
Janus Kinase Inhibitors
Alopecia Areata
Interventions
First Posted Date
2024-08-27
Last Posted Date
2024-08-27
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
150
Registration Number
NCT06573593
Locations
🇨🇳

Second Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, China

Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Phase 2
Active, not recruiting
Conditions
Chronic Hand Eczema
Interventions
First Posted Date
2024-02-28
Last Posted Date
2025-04-17
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
84
Registration Number
NCT06283550
Locations
🇨🇦

INNO-6052 Site 12, Fredericton, New Brunswick, Canada

🇨🇦

INNO-6052 Site 13, Cobourg, Ontario, Canada

🇨🇦

INNO-6052 Site 11, Montréal, Quebec, Canada

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Early Phase 1
Recruiting
Conditions
Toxic Epidermal Necrolysis
Interventions
First Posted Date
2023-11-07
Last Posted Date
2023-11-28
Lead Sponsor
Peng Zhang
Target Recruit Count
30
Registration Number
NCT06119490
Locations
🇨🇳

Department of Dermatology, the First Affiliated Hospital of Fujian Medical University., Fuzhou, Fujian, China

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

Phase 2
Recruiting
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2023-02-24
Last Posted Date
2024-10-21
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
78
Registration Number
NCT05743244
Locations
🇺🇸

Children's Hospital Orange County, Orange, California, United States

🇺🇸

Stanford University, Palo Alto, California, United States

🇺🇸

University of California- San Francisco, San Francisco, California, United States

and more 17 locations

A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring

Recruiting
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2023-02-10
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
400
Registration Number
NCT05721937
Locations
🇺🇸

Pfizer, New York, New York, United States

Janus Kinase Inhibition in Sarcoidosis

Phase 2
Completed
Conditions
Sarcoidosis
Interventions
First Posted Date
2023-01-25
Last Posted Date
2025-05-16
Lead Sponsor
Yale University
Target Recruit Count
10
Registration Number
NCT05696795
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

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