Clinical Trials

Numerous clinical trials evaluate ruxolitinib across Phase 1 safety and pharmacokinetic evaluations through Phase 3 efficacy trials, with statuses spanning active, recruiting, completed, and terminated. Sponsored by both commercial entities and leading academic research centers, these investigations target diverse conditions, including myeloproliferative neoplasms such as myelofibrosis, inflammatory disorders like psoriasis and rheumatoid arthritis, and solid tumors such as breast cancer. Studies assess both monotherapies and combination regimens to determine safety and efficacy across hematologic, dermatologic, and oncologic applications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03954236 ACTIVE_NOT_RECRUITING
Non-sclerotic Cutaneous Chronic Graft-versus-host Disease
Memorial Sloan Kettering Cancer Center
 2019-05-14 PHASE2
NCT06479135 RECRUITING
Myelofibrosis; Post-PV MF; Post-ET Myelofibrosis; Primary Myelofibrosis; MF
Kartos Therapeutics, Inc.
 2024-06-03 PHASE3
NCT01644110 COMPLETED
Primary Myelofibrosis; Secondary Myelofibrosis; PMF; SMF; Post-PV MF; Post-ET MF
University of Ulm
 2013-08 PHASE1; PHASE2
NCT06310304 Active not recruiting
Healthy Participants
Incyte Corporation
 2024-03-26 Phase 1
NCT02876302 COMPLETED
Inflammatory Breast Cancer (IBC)
Dana-Farber Cancer Institute
 2018-01-24 PHASE2
NCT03697460 COMPLETED
Lichen Planus
Aaron R. Mangold
 2018-08-30 PHASE2
NCT01348490 COMPLETED
MPN (Myeloproliferative Neoplasms)
Incyte Corporation
 2011-06-15 PHASE2
NCT03099304 COMPLETED
Vitiligo
Incyte Corporation
 2017-06-07 PHASE2
NCT03011892 COMPLETED
Atopic Dermatitis
Incyte Corporation
 2017-01-09 PHASE2
NCT00674479 COMPLETED
Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia
M.D. Anderson Cancer Center
 2008-05-12 PHASE2
NCT01594216 COMPLETED
Estrogen-receptor Positive Invasive Metastatic Breast Cancer
Abramson Cancer Center at Penn Medicine
 2012-04 PHASE2
NCT01562873 TERMINATED
Breast Cancer
Dana-Farber Cancer Institute
 2012-06 PHASE2
NCT02596347 Completed
Chronic Beryllium Disease (CBD)|Beryllium Sensitization (BeS)
National Jewish Health
 2015-04 --
NCT01164163 COMPLETED
Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Unspecified Childhood Solid Tumor, Protocol Specific
Children's Oncology Group
 2010-09 PHASE1
NCT01340651 COMPLETED
Myelofibrosis
Incyte Corporation
 2011-03 PHASE2
NCT00952289 COMPLETED
MPN (Myeloproliferative Neoplasms)
Incyte Corporation
 2009-08 PHASE3
NCT00639002 COMPLETED
Multiple Myeloma
Incyte Corporation
 2008-03 PHASE2
NCT00726232 TERMINATED
Myeloproliferative Neoplasm (MPN)
Incyte Corporation
 2008-08-20 PHASE2
NCT00778700 COMPLETED
Psoriasis
Incyte Corporation
 2008-10-28 PHASE2
NCT00638378 TERMINATED
Prostate Cancer
Incyte Corporation
 2008-02 PHASE2
NCT00550043 COMPLETED
Rheumatoid Arthritis
Incyte Corporation
 2007-10 PHASE2
NCT00509899 COMPLETED
Myelofibrosis; Polycythemia Vera; Thrombocytosis
Incyte Corporation
 2007-06 PHASE1; PHASE2
NCT00617994 Completed
Psoriasis
Incyte Corporation
 2007-08-31 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the S-Ruxolitinib (INCB018424) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

S-Ruxolitinib selectively binds to Janus kinases 1 and 2 (JAK1/2) with IC50 values of 3.3 nM and 2.8 nM, respectively, blocking ATP binding and inhibiting downstream STAT protein phosphorylation and gene transcription. This suppression of constitutive JAK-STAT pathway signaling impairs pro-inflammatory cytokine transmission and malignant hematopoietic cell proliferation, demonstrating clinical relevance in the targeted treatment of myelofibrosis, myeloproliferative neoplasms, and autoimmune disorders.

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.