Clinical Trials

Abrocitinib is evaluated across numerous clinical trials and observational studies spanning Early Phase 1 through Phase 4, focusing primarily on dermatological and inflammatory conditions such as atopic dermatitis, eczema, psoriasis, sarcoidosis, and post-COVID fatigue. Industry sponsors including Pfizer lead the majority of these studies, complemented by academic and medical institutions such as Beth Israel Deaconess Medical Center and Yale University. Trial recruitment statuses encompass active and non-recruiting phases, as well as completed bioequivalence and pharmacokinetic evaluations in healthy subjects and renal impairment cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06807281 RECRUITING
Atopic Dermatitis
Pfizer
 2025-12-02 PHASE3
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT06807268 RECRUITING
Eczema
Pfizer
 2025-07-24 PHASE3
NCT07242638 RECRUITING
Atopic Dermatitis; Alopecia Areata
Icahn School of Medicine at Mount Sinai
 2026-01-12 PHASE2
NCT05743244 ACTIVE_NOT_RECRUITING
Diabetes Mellitus, Type 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2023-10-19 PHASE2
NCT06119490 RECRUITING
Toxic Epidermal Necrolysis
Peng Zhang
 2023-07-05 EARLY_PHASE1
NCT06597396 ACTIVE_NOT_RECRUITING
Post-COVID Condition; Fatigue Symptom
Beth Israel Deaconess Medical Center
 2024-12-27 PHASE2
NCT03422822 COMPLETED
Dermatitis, Atopic
Pfizer
 2018-03-08 PHASE3
NCT06283550 COMPLETED
Chronic Hand Eczema
Innovaderm Research Inc.
 2024-05-31 PHASE2
NCT05069831 COMPLETED
Food Allergy
Icahn School of Medicine at Mount Sinai
 2022-05-16 PHASE1
NCT05696795 COMPLETED
Sarcoidosis
Yale University
 2023-06-01 PHASE2
NCT05602207 COMPLETED
Atopic Dermatitis
Innovaderm Research Inc.
 2022-11-25 PHASE4
NCT05650736 ACTIVE_NOT_RECRUITING
Granuloma Annulare
William Damsky
 2023-10-27 PHASE2
NCT06353087 Not yet recruiting
Dermatitis Atopic|Dermatitis|Eczema|Skin Diseases|Immune System Diseases|Janus Kinase Inhibitors
Pfizer
 2024-04-01 --
NCT05375929 COMPLETED
Atopic Dermatitis
Pfizer
 2022-07-16 PHASE3
NCT05038982 COMPLETED
Prurigo Nodularis; Pruritus; Chronic Pruritus; Chronic Prurigo; Skin Diseases
Johns Hopkins University
 2021-09-09 PHASE2
NCT05067439 COMPLETED
Healthy Participants
Pfizer
 2021-10-21 PHASE1
NCT03915496 COMPLETED
Atopic Dermatitis
Pfizer
 2020-06-18 PHASE2
NCT04903093 COMPLETED
Healthy Volunteers
Pfizer
 2021-06-04 PHASE1
NCT04345367 COMPLETED
Atopic Dermatitis
Pfizer
 2020-06-11 PHASE3
NCT03627767 COMPLETED
Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases
Pfizer
 2018-06-11 PHASE3
NCT03796676 COMPLETED
Atopic Dermatitis
Pfizer
 2019-02-18 PHASE3
NCT03720470 COMPLETED
Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases
Pfizer
 2018-10-29 PHASE3
NCT04065633 COMPLETED
Dermatitis, Atopic
Pfizer
 2019-07-18 PHASE1
NCT04099563 COMPLETED
HEALTHY
Pfizer
 2019-10-14 PHASE1
NCT03660241 COMPLETED
Renal Impairment
Pfizer
 2018-10-05 PHASE1
NCT03575871 COMPLETED
Dermatitis, Atopic
Pfizer
 2018-06-29 PHASE3
NCT03937258 COMPLETED
Healthy
Pfizer
 2019-05-21 PHASE1
NCT04065633 Completed
Dermatitis Atopic
Pfizer
 2019-07-18 Phase 1
NCT03937258 Completed
Healthy
Pfizer
 2019-05-21 Phase 1
NCT03626415 COMPLETED
Hepatic Impairment
Pfizer
 2018-10-01 PHASE1
NCT03349060 COMPLETED
Dermatitis, Atopic
Pfizer
 2017-12-07 PHASE3
NCT03806101 COMPLETED
Healthy
Pfizer
 2019-01-23 PHASE1
NCT03742336 COMPLETED
Healthy
Pfizer
 2018-11-21 PHASE1
NCT03796182 COMPLETED
Healthy
Pfizer
 2019-01-10 PHASE1
NCT03796676 Completed
Atopic Dermatitis
Pfizer
 2019-02-18 Phase 3
NCT03662516 COMPLETED
Healthy Females
Pfizer
 2018-09-26 PHASE1
NCT03637790 COMPLETED
Healthy
Pfizer
 2018-09-13 PHASE1
NCT03634345 COMPLETED
Dermatitis, Atopic
Pfizer
 2018-09-12 PHASE1
NCT03647670 COMPLETED
Phase 1
Pfizer
 2018-07-03 PHASE1
NCT03386279 COMPLETED
Healthy Volunteers
Pfizer
 2018-07-02 PHASE1
NCT03660241 Completed
Renal Impairment
Pfizer
 2018-10-05 Phase 1
NCT03250039 COMPLETED
Healthy
Pfizer
 2017-07-10 PHASE1
NCT02780167 COMPLETED
Atopic Dermatitis
Pfizer
 2016-04 PHASE2
NCT02201524 TERMINATED
Plaque Psoriasis
Pfizer
 2014-11 PHASE2
NCT02163161 COMPLETED
Healthy
Pfizer
 2014-06 PHASE1
NCT01835197 COMPLETED
Healthy
Pfizer
 2013-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Abrocitinib (PF-04965842) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abrocitinib is a potent selective inhibitor of Janus kinase 1 (JAK1) that blocks JAK1-dependent intracellular phosphorylation and downstream STAT protein activation. By suppressing signaling pathways mediated by key pro-inflammatory cytokines, abrocitinib disrupts T-cell activation and epidermal immune cascades, thereby alleviating cutaneous inflammation and pruritus in inflammatory skin diseases like atopic dermatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.