Clinical Trials

Multiple clinical trials evaluate clioquinol across Phase 1, Phase 2, Phase 3, and unspecified phases for hematological malignancies, dermatological conditions, and neurological disorders. Sponsored by both academic medical centers and pharmaceutical organizations, these studies target indications such as acute myeloid leukemia, multiple myeloma, eczema, seborrheic dermatitis, scalp psoriasis, and drug-resistant childhood epilepsy. Recruitment statuses across these trials vary, encompassing completed, terminated, and unknown designations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05727943 UNKNOWN
Epilepsy Intractable
KU Leuven
2022-03-01 PHASE2
NCT00963495 TERMINATED
Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Lymphoma, Non-Hodgkin; Hodgkin's Lymphoma; Multiple Myeloma
University Health Network, Toronto
2009-08 PHASE1
NCT01429701 COMPLETED
Eczema
EMS
2012-05 PHASE3
NCT00963495 Terminated
Acute Myeloid Leukemia|Acute Lymphocytic Leukemia|Chronic Lymphocytic Leukemia|Myelodysplasia|Lymphoma Non-Hodgkin|Hodgkin''s Lymphoma|Multiple Myeloma
University Health Network Toronto
2009-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2023-02-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a lipophilic, copper-binding hydroxyquinoline derivative, clioquinol acts by chelating transition metal ions to disrupt intracellular copper homeostasis and inhibit proteasomal function, which induces reactive oxygen species accumulation and drives apoptotic cell death. This pathway-targeted cytotoxicity and antimicrobial activity provide the biological rationale for its clinical investigation in hematological malignancies, intractable epilepsy, and inflammatory dermatological conditions.

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.