Clinical Trials

Multiple clinical trials across Phase I and Phase II have evaluated Quinacrine for oncology, autoimmune, and neurodegenerative conditions, including prostate, non-small cell lung, renal cell, and colorectal cancers, Creutzfeldt-Jakob disease, and cutaneous lupus erythematosus. Sponsored by organizations such as Cleveland BioLabs, the University of California San Francisco, Fox Chase Cancer Center, and the Medical Research Council, these studies encompass completed, actively recruiting, withdrawn, and terminated statuses. Currently, Phase II research continues to evaluate its therapeutic utility in active cutaneous lupus erythematosus.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07694336 RECRUITING
Cutaneous Lupus Erythematosus (CLE)
Victoria Werth
 2026-06-30 PHASE2
NCT01844076 TERMINATED
Colorectal Adenocarcinoma
Fox Chase Cancer Center
 2016-01-14 PHASE1; PHASE2
NCT01839955 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
Neelesh Sharma MD PhD
 2013-09 PHASE1
NCT00183092 COMPLETED
Creutzfeldt-Jakob Disease
University of California, San Francisco
 2005-04 PHASE2
NCT00417274 COMPLETED
Prostatic Cancer
Cleveland BioLabs
 2006-12 PHASE2
NCT00574483 WITHDRAWN
Renal Cell Carcinoma
Cleveland BioLabs
 2007-11 PHASE2
NCT00417274 Completed
Prostatic Cancer
Cleveland BioLabs
 2006-12 Phase 2
NCT00104663 COMPLETED
Prion Disease
Medical Research Council
 2004-06

(data from https://clinicaltrials.gov, updated on 2026-08-12)

Check the Quinacrine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quinacrine 2HCl functions as a lipophilic cationic inhibitor of phospholipase A2, directly binding to the enzyme to prevent the enzymatic release of arachidonic acid and downstream eicosanoid signaling cascades. This enzymatic blockade suppresses pro-inflammatory signaling and tumor cell proliferation, providing a rational biological basis for its therapeutic investigation in solid tumors like non-small cell lung cancer as well as autoimmune disorders such as cutaneous lupus erythematosus.

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.