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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

Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis

Conditions
Atopic Dermatitis
First Posted Date
2020-09-25
Last Posted Date
2024-10-29
Lead Sponsor
Pfizer
Registration Number
NCT04564755
Locations
🇺🇸

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

🇺🇸

Cahaba Dermatology and Skin Health Center, Birmingham, Alabama, United States

🇺🇸

Antelope Valley Clinical Trials, Lancaster, California, United States

and more 52 locations

Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
Combination Product: Dupilumab 300 mg
First Posted Date
2020-04-14
Last Posted Date
2022-07-08
Lead Sponsor
Pfizer
Target Recruit Count
727
Registration Number
NCT04345367
Locations
🇺🇸

One Health Research Clinic, Norcross, Georgia, United States

🇺🇸

Paddington Testing Co, Inc., Philadelphia, Pennsylvania, United States

🇵🇱

Centrum Medyczne Promed, Krakow, Poland

and more 146 locations

Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants

Phase 1
Completed
Conditions
HEALTHY
Interventions
First Posted Date
2019-09-23
Last Posted Date
2020-01-02
Lead Sponsor
Pfizer
Target Recruit Count
13
Registration Number
NCT04099563
Locations
🇨🇳

Beijing Hospital Sub-Center of Beijing Hospital Clinical Trial & Research Center, Beijing, China

A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-05-03
Last Posted Date
2019-10-18
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT03937258
Locations
🇺🇸

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

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2019-04-16
Last Posted Date
2023-02-08
Lead Sponsor
Pfizer
Target Recruit Count
46
Registration Number
NCT03915496
Locations
🇺🇸

The Indiana Clinical Trials Center, PC - Dermatology Research, Plainfield, Indiana, United States

🇺🇸

Keck School of Medicine of USC - IDS Pharmacy, Los Angeles, California, United States

🇺🇸

ForCare Clinical Research, Tampa, Florida, United States

and more 8 locations

Study of PF-04965842 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-01-16
Last Posted Date
2019-05-06
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT03806101
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2019-01-08
Last Posted Date
2022-04-13
Lead Sponsor
Pfizer
Target Recruit Count
287
Registration Number
NCT03796676
Locations
🇺🇸

UC Davis, Sacramento, California, United States

🇺🇸

AdventHealth Orlando, Orlando, Florida, United States

🇺🇸

Madera Family Medical Group, Madera, California, United States

and more 127 locations

Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-01-08
Last Posted Date
2020-02-05
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT03796182
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2018-11-15
Last Posted Date
2020-02-28
Lead Sponsor
Pfizer
Target Recruit Count
20
Registration Number
NCT03742336
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

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