Abrocitinib

Overview

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.	2025/03/27	NCT06899204	N/A	Not yet recruiting	Pfizer
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema	2025/02/04	NCT06807268	Phase 3	Recruiting	Pfizer
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema	2025/02/04	NCT06807281	Phase 3	Not yet recruiting	Pfizer
Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID	2024/09/19	NCT06597396	Phase 2	Recruiting	Beth Israel Deaconess Medical Center
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study	2024/08/27	NCT06573593	N/A	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy	2024/02/28	NCT06283550	Phase 2	Active, not recruiting	Innovaderm Research Inc.
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis	2023/11/07	NCT06119490	Early Phase 1	Recruiting	Peng Zhang
Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)	2023/02/24	NCT05743244	Phase 2	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring	2023/02/10	NCT05721937	N/A	Recruiting	Pfizer
Janus Kinase Inhibition in Sarcoidosis	2023/01/25	NCT05696795	Phase 2	Completed	Yale University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CIBINQO	U.S. Pharmaceuticals	63539-436	ORAL	200 mg in 1 1	12/19/2023
Cibinqo	Pfizer Laboratories Div Pfizer Inc	0069-0235	ORAL	50 mg in 1 1	2/13/2023
CIBINQO	U.S. Pharmaceuticals	63539-236	ORAL	50 mg in 1 1	12/19/2023
Cibinqo	Pfizer Laboratories Div Pfizer Inc	0069-0335	ORAL	100 mg in 1 1	2/13/2023
Cibinqo	Pfizer Laboratories Div Pfizer Inc	0069-0435	ORAL	200 mg in 1 1	2/13/2023
CIBINQO	U.S. Pharmaceuticals	63539-336	ORAL	100 mg in 1 1	12/19/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Cibinqo	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	12/9/2021
Cibinqo	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	12/9/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
CIBINQO Film-Coated Tablet 200 mg	Pfizer Manufacturing Deutschland GmbH	SIN16414P	TABLET, FILM COATED	200.00 mg	1/5/2022
CIBINQO Film-Coated Tablet 100 mg	Pfizer Manufacturing Deutschland GmbH	SIN16413P	TABLET, FILM COATED	100.00 mg	1/5/2022
CIBINQO Film-Coated Tablet 50 mg	Pfizer Manufacturing Deutschland GmbH	SIN16412P	TABLET, FILM COATED	50.00 mg	1/5/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Abrocitinib Tablets	PFIZER INC.	国药准字HJ20220031	化学药品	片剂	4/8/2022
Abrocitinib Tablets	PFIZER INC.	国药准字HJ20220029	化学药品	片剂	4/8/2022
Abrocitinib Tablets	PFIZER INC.	国药准字HJ20220030	化学药品	片剂	4/8/2022

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CIBINQO abrocitinib 200 mg tablet blister pack	346351	Pfizer Australia Pty Ltd	Medicine	A	4/16/2024
CIBINQO abrocitinib 50 mg tablet blister pack	346349	Pfizer Australia Pty Ltd	Medicine	A	4/16/2024
CIBINQO abrocitinib 100 mg tablet blister pack	346350	Pfizer Australia Pty Ltd	Medicine	A	4/16/2024

Related News

CDSCO Expert Committee Accepts Pfizer's Phase III Data for Abrocitinib in Atopic Dermatitis

12 days ago

India's CDSCO expert committee has accepted Pfizer's Phase III clinical trial data for abrocitinib, a selective JAK1 inhibitor for moderate-to-severe atopic dermatitis treatment.

Sanofi's Amlitelimab Shows Promising Results in Atopic Dermatitis Trial Following $1.45bn Kymab Acquisition

3 months ago

• Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose. • The OX40 ligand-targeting antibody showed durable effects, with two-thirds of patients maintaining clear or almost clear skin 24 weeks after the final dose, positioning it as a potential complement to Sanofi's blockbuster Dupixent. • Despite increasing competition in the atopic dermatitis market from biologics and JAK inhibitors, Sanofi is advancing amlitelimab to Phase 2b trials, emphasizing the need for diverse treatment options for this challenging condition.

JAK Inhibitors Show Promising Long-term Safety and Efficacy in Atopic Dermatitis Treatment, Yale Expert Reports

5 months ago

• Yale dermatology expert Dr. Christopher Bunick presents compelling data showing JAK inhibitors like upadacitinib and abrocitinib provide faster skin and itch relief compared to dupilumab in atopic dermatitis treatment. • Six-year safety data reveals JAK inhibitors demonstrate lower rates of major cardiovascular and thromboembolic events in atopic dermatitis patients compared to the general patient population. • Emerging research on TYK2 inhibitors, including deucravacitinib and zasocitinib, shows promise for expanding treatment options in inflammatory skin conditions.

FDA Approves Opzelura as First Topical JAK Inhibitor for Atopic Dermatitis

6 months ago

Incyte's Opzelura (ruxolitinib) cream has received FDA approval as the first topical JAK inhibitor for treating atopic dermatitis in adolescents and adults who failed other topical therapies.

Abrocitinib Shows Sustained Efficacy in Treating Moderate-to-Severe Atopic Dermatitis

7 months ago

• Abrocitinib demonstrates rapid and sustained improvements in adolescents and adults with moderate-to-severe atopic dermatitis over 72 weeks. • The JADE REAL study provided early access to abrocitinib for patients inadequately controlled by existing topical and systemic treatments. • Participants experienced significant reductions in EASI scores, PP-NRS, BSA involvement, and POEM scores, indicating comprehensive disease control. • The most common treatment-emergent adverse events were COVID-19 and nausea, with most cases being mild to moderate in severity.

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