Several clinical trials are investigating Dimercaprol across respiratory, infectious, and post-transplantation conditions, including mild allergic and bronchial asthma, COVID-19, multi-site bacterial infections, and post-allogeneic hematopoietic stem cell transplantation lung complications. Supported by academic and federal institutions, including McMaster University, the Fraunhofer-Institute, Mansoura University, Washington University School of Medicine, and the National Institutes of Health, these studies comprise Phase 2, non-applicable, and unassigned phase protocols. Active recruitment for these trials is either currently ongoing or slated to begin shortly.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06317909 | Recruiting | Mild Allergic Asthma |
Fraunhofer-Institute of Toxicology and Experimental Medicine |
2024-06-01 | Not Applicable |
| NCT06381739 | Not yet recruiting | COVID-19 Infection |
McMaster University|Canadian Institutes of Health Research (CIHR) |
2024-06 | Phase 2 |
| NCT06376617 | Not yet recruiting | Bronchial Asthma |
Mansoura University |
2024-04-25 | Not Applicable |
| NCT03482245 | Recruiting | Pneumonia|Necrotizing Soft Tissue Infection|Intraabdominal Infections|Infection Joint |
Washington University School of Medicine|National Institute of General Medical Sciences (NIGMS) |
2024-04-16 | Not Applicable |
| NCT06093867 | Recruiting | Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
National Heart Lung and Blood Institute (NHLBI)|National Institutes of Health Clinical Center (CC) |
2024-04-08 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).