Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by academic centers, research councils, and biopharmaceutical organizations have evaluated Quinacrine across oncological, neurodegenerative, and autoimmune conditions. Featuring active, completed, and terminated or withdrawn statuses, these studies have examined therapeutic applications in non-small cell lung cancer, metastatic prostate cancer, renal cell carcinoma, colorectal adenocarcinoma, Creutzfeldt-Jakob disease, prion diseases, and cutaneous lupus erythematosus. Overall, these investigations assess the safety, drug levels, and combinatorial efficacy of Quinacrine in solid tumors and specialized pathologies.

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NCT00574483 WITHDRAWN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
NCT00104663 COMPLETED
Prion Disease
Medical Research Council
 2004-06

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quinacrine intercalates into nuclear DNA and inhibits nuclear factor-kappa B (NF-κB) activation, thereby suppressing downstream anti-apoptotic gene expression and pro-inflammatory signal transduction pathways. This disruption of cell survival signaling leads to enhanced apoptotic death and cell cycle arrest in dysregulated target cells, demonstrating therapeutic relevance in clinical trials targeting advanced solid tumors—such as non-small cell lung cancer and colorectal adenocarcinoma—as well as autoimmune conditions like 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.