Clinical Trials

Multiple clinical trials are evaluating WP1066 for advanced central nervous system malignancies and intracranial metastases, including pediatric and adult brain tumors, medulloblastoma, recurrent malignant glioma, IDH-wildtype glioblastoma, and melanoma brain metastases. Led predominantly by academic research institutions such as Emory University, Northwestern University, and M.D. Anderson Cancer Center, these Phase 1 and Phase 2 studies range from completed early-phase safety evaluations to active combination trials with radiation therapy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05879250 RECRUITING
Glioblastoma, IDH-Wildtype; MGMT-Unmethylated Glioblastoma
Northwestern University
2024-05-22 PHASE2
NCT04334863 COMPLETED
Brain Tumor; Medulloblastoma; Brain Metastases
Emory University
2020-05-04 PHASE1
NCT01904123 COMPLETED
Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Recurrent Brain Neoplasm; Recurrent Glioblastoma; Recurrent Malignant Glioma
M.D. Anderson Cancer Center
2018-07-13 PHASE1
NCT04334863 Completed
Brain Tumor|Medulloblastoma|Brain Metastases
Emory University|CURE Childhood Cancer Inc.|Peach Bowl LegACy Fund
2020-05-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-22)

Check the WP1066 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

WP1066 selectively inhibits the phosphorylation of JAK2 and STAT3 (IC50 = 2.30 μM and 2.43 μM, respectively), blocking downstream STAT5 and ERK1/2 signaling cascades to induce G0/G1 cell cycle arrest and caspase-dependent apoptosis. By suppressing oncogenic STAT3 activation and downstream HIF transcription factors, this targeting mechanism disrupts tumor cell survival and proliferation, providing therapeutic relevance for treating central nervous system malignancies such as glioblastoma, medulloblastoma, and brain metastases.

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>).

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