Back to discover
Drug

Abrocitinib

Approved · FDA / EMA
ClassTyrosine-protein kinase JAK1 inhibitorEmerging researchLate-stage development

Also known as Cibinqo.

RxNorm2591476ChEMBLCHEMBL3655081ATCD11AH08UNII73SM5SF3OR
1
Research papers
7
Active clinical trials
Tyrosine-protein kinase JAK1
Primary target
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Label change: ABROCITINIB (NDA213871)

Regulatory2026-06-30FDA

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Clinical trial2026-05-06Results expected Q2 2027 · ClinicalTrials.gov

A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis

Clinical trial2026-04-07Results expected Q1 2032 · ClinicalTrials.gov

A Phase 2a Randomized, Dose Ranging, Double-Blind, 3-Arm Study to Investigate Orally Administered Abrocitinib Compared With Placebo in Non-Hospitalized Symptomatic Adult Participants With Severe Fatigue From Post COVID Condition

Clinical trial2026-03-27Primary completion · ClinicalTrials.gov

Use of Specific JAK Inhibition on Inflammatory Skin and Scalp Diseases in Down Syndrome R61AR084210

Clinical trial2026-02-02Results expected Q1 2027 · ClinicalTrials.gov

A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Clinical trial2025-12-22Completed · ClinicalTrials.gov

Indication expansion: ABROCITINIB (NDA213871)

Regulatory2023-12-14FDA

Indication expansion: ABROCITINIB (NDA213871)

Regulatory2023-02-09FDA

Approval: ABROCITINIB (NDA213871)

Regulatory2022-01-14FDA

Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.

Research2020-07-01Lancet (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Abrocitinib
Aliases & brands
Cibinqo
RxNorm CUI
2591476
ChEMBL ID
CHEMBL3655081
ATC codes
D11AH08
UNII
73SM5SF3OR
Primary mechanism
Tyrosine-protein kinase JAK1 inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tyrosine-protein kinase JAK1
JAK1 · P23458
INHIBITORTyrosine-protein kinase JAK1 inhibitor

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2021-12-09 → 2023-12-14)
Earliest approval
2021-12-09
Latest approval
2023-12-14
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-30Label change
Label change: ABROCITINIB (NDA213871)
Evidence ↗
2023-12-14Indication expansionMulti-authority
Indication expansion: ABROCITINIB (NDA213871)
Evidence ↗
2023-02-09Indication expansionMulti-authority
Indication expansion: ABROCITINIB (NDA213871)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2021-12-09ApprovalMulti-authority
Approval: Cibinqo (EMA)

Indication: Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

17 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
17
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
5
Recruiting
7
Late-stage (III+)
10
Completed
PHASE DISTRIBUTIONn = 17
Early Phase 11Phase 13Phase 26Phase 35Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab

CompletedPH IVInnovaderm Research Inc.n=242025

A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis

RecruitingPH IIIPfizern=5002032

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

RecruitingPH IIIPfizern=1502027

A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

CompletedPH IIIKey trialPfizern=3,1662025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

CompletedPH IIIKey trialPfizern=3,1662025

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

CompletedPH IIInnovaderm Research Inc.n=822025

JAK Inhibition in Food Allergy

CompletedPH IIcahn School of Medicine at Mount Sinain=712025

JAK1 Inhibition in Sarcoidosis: an Opportunity for Pathogenesis Directed Therapy

CompletedPH IIYale Universityn=102025

Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab

CompletedPH IVInnovaderm Research Inc.n=242025

A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABROCITINIB 100 MG AND 200 MG TABLETS IN PARTICIPANTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS IN INDIA

CompletedPH IIIPfizern=2002024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Lancet (London, England)1
Leading researchers
  • Aschoff R1
  • Bieber T1
  • Biswas P1
  • Cork M1
  • Feeney C1
  • Flohr C1
  • Forman S1
  • Maari C1
Leading institutions
free-text, unnormalised
  • Canada; University of Montreal Hospital Center1
  • ForCare Clinical Research1
  • Herlev-Gentofte Hospital1
  • Ludwig Maximilian University of Munich1
  • Miami Itch Center1
  • Oregon Health & Science University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.