Clinical Trials

Numerous clinical trials across early- to late-stage development evaluate brepocitinib across various autoimmune and inflammatory conditions, including dermatomyositis, non-infectious uveitis, cutaneous sarcoidosis, lichen planopilaris, cicatricial alopecia, and chronic plaque psoriasis, alongside pharmacokinetic assessments in healthy volunteers and renally impaired individuals. Sponsored by pharmaceutical companies such as Pfizer and Priovant Therapeutics alongside academic institutions like the Icahn School of Medicine at Mount Sinai, these studies exhibit recruitment statuses ranging from completed to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06978725 RECRUITING
Cutaneous Sarcoidosis
Priovant Therapeutics, Inc.
 2025-04-09 PHASE2; PHASE3
NCT07532603 RECRUITING
Lichen Planopilaris
Priovant Therapeutics, Inc.
 2026-03-19 PHASE2; PHASE3
NCT06431373 ACTIVE_NOT_RECRUITING
Uveitis, Posterior; Uveitis, Intermediate; Uveitis
Priovant Therapeutics, Inc.
 2024-09-11 PHASE3
NCT05437263 ACTIVE_NOT_RECRUITING
Dermatomyositis
Priovant Therapeutics, Inc.
 2022-10-31 PHASE3
NCT06433999 COMPLETED
Dermatomyositis; Dermatomyositis, Adult Type
Priovant Therapeutics, Inc.
 2024-08-28 PHASE2
NCT05523765 COMPLETED
Non-infectious Intermediate Uveitis; Non-infectious Posterior Uveitis; Non-infectious Pan Uveitis
Priovant Therapeutics, Inc.
 2022-11-14 PHASE2
NCT03395184 COMPLETED
Crohn's Disease
Pfizer
 2018-02-02 PHASE2
NCT03845517 COMPLETED
Systemic Lupus Erythematosus
Pfizer
 2019-04-18 PHASE2
NCT05076006 COMPLETED
Cicatricial Alopecia
Emma Guttman
 2021-05-19 PHASE2
NCT04260464 COMPLETED
Healthy Volunteer; Renal Impairment
Pfizer
 2020-07-03 PHASE1
NCT04092452 COMPLETED
Acne Inversa
Pfizer
 2019-12-02 PHASE2
NCT02958865 COMPLETED
Ulcerative Colitis
Pfizer
 2017-02-03 PHASE2
NCT05076006 Completed
Cicatricial Alopecia
Emma Guttman|Pfizer|Icahn School of Medicine at Mount Sinai
 2021-05-19 Phase 2
NCT03850483 COMPLETED
Psoriasis
Pfizer
 2019-04-08 PHASE2
NCT03715829 COMPLETED
Active Non-segmental Vitiligo
Pfizer
 2018-11-26 PHASE2
NCT04580797 COMPLETED
Healthy Participants
Pfizer
 2020-10-02 PHASE1
NCT04267250 COMPLETED
Healthy Female Volunteers
Pfizer
 2020-08-24 PHASE1
NCT04260464 Completed
Healthy Volunteer|Renal Impairment
Pfizer
 2020-07-03 Phase 1
NCT03903822 COMPLETED
Atopic Dermatitis
Pfizer
 2019-05-13 PHASE2
NCT03963401 COMPLETED
Psoriatic Arthritis
Pfizer
 2019-06-13 PHASE2
NCT04090047 COMPLETED
Heathy Participants
Pfizer
 2019-09-24 PHASE1
NCT04090047 Completed
Heathy Participants
Pfizer
 2019-09-24 Phase 1
NCT02974868 COMPLETED
Alopecia Areata
Pfizer
 2016-12-15 PHASE2
NCT03916250 COMPLETED
Healthy
Pfizer
 2019-03-23 PHASE1
NCT03765554 COMPLETED
Healthy Participants
Pfizer
 2019-01-07 PHASE1
NCT03770039 COMPLETED
Healthy Male Subjects
Pfizer
 2018-12-10 PHASE1
NCT03656952 COMPLETED
Healthy
Pfizer
 2018-09-05 PHASE1
NCT02969018 COMPLETED
Chronic Plaque Psoriasis
Pfizer
 2016-12 PHASE2
NCT03236493 COMPLETED
Healthy
Pfizer
 2017-08-16 PHASE1
NCT02310750 COMPLETED
Plaque Psoriasis
Pfizer
 2014-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the Brepocitinib (PF-06700841) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brepocitinib acts as a potent dual inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) with IC50 values of 23 nM and 17 nM, respectively, thereby blocking ATP binding and suppressing downstream signal transducer and activator of transcription (STAT) phosphorylation. By inhibiting these intracellular cytokine signaling cascades, brepocitinib reduces proinflammatory immune cell activation and pathogenic cytokine release, providing direct therapeutic relevance for autoimmune and inflammatory conditions investigated in clinical trials such as dermatomyositis, non-infectious uveitis, and chronic plaque psoriasis.

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>).

Jump to

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