Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Pfizer have evaluated the safety, pharmacokinetics, and efficacy of ropsacitinib in healthy participants and patients with inflammatory conditions. Phase 1 studies assessed single- and multiple-dose tolerability and pharmacokinetic interactions, while mostly completed Phase 2 trials expanded evaluation to plaque psoriasis and acne inversa. Additionally, a Phase 2b study targeting ulcerative colitis was initiated but subsequently withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04209556 WITHDRAWN
Ulcerative Colitis
Pfizer
 2020-09-30 PHASE2
NCT04092452 COMPLETED
Acne Inversa
Pfizer
 2019-12-02 PHASE2
NCT04591262 COMPLETED
Healthy
Pfizer
 2020-11-10 PHASE1
NCT03895372 COMPLETED
Psoriasis
Pfizer
 2019-06-27 PHASE2
NCT04134715 COMPLETED
Healthy
Pfizer
 2019-10-23 PHASE1
NCT04134715 Completed
Healthy
Pfizer
 2019-10-23 Phase 1
NCT03210961 COMPLETED
Plaque Psoriasis
Pfizer
 2017-07-14 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-12-17)

Check the Ropsacitinib (PF-06826647) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ropsacitinib selectively binds to the catalytically active JH1 domain of tyrosine kinase 2 (TYK2), inhibiting its enzymatic activity and blocking downstream STAT phosphorylation and signal transduction. This suppression of inflammatory cytokine signaling reduces pro-inflammatory immune cell activation, demonstrating clinical relevance for managing inflammatory autoimmune conditions such as plaque psoriasis, ulcerative colitis, and acne inversa.

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.