Clinical Trials

Sponsored by MEI Pharma, Inc., a Phase 1 open-label clinical trial evaluated voruciclib in patients with acute myeloid leukemia or various relapsed or refractory B-cell malignancies. The study examined specific hematologic conditions, including follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and acute myeloid leukemia. According to official records, recruitment for this early-phase trial has been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03547115 TERMINATED
Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Marginal Zone Lymphoma (MZL); Small Lymphocytic Lymphoma (SLL); Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-cell Lymphoma (DLBCL); Acute Myeloid Leukemia (AML)
MEI Pharma, Inc.
 2018-05-31 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voruciclib functions as a pan-cyclin-dependent kinase inhibitor that potently targets CDK9, thereby repressing downstream MCL-1 expression and inducing cell apoptosis. This inhibition of CDK9-mediated cell survival mechanisms blocks tumor cell proliferation, providing therapeutic relevance for treating B-cell malignancies such as diffuse large B-cell lymphoma and acute myeloid leukemia.

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.