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)
Mechanism and Biochemical Profile
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>).