Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dimercaprol acts as an acrolein scavenger that directly inhibits human immunodeficiency virus type 1 (HIV-1) Tat protein activity, thereby suppressing downstream viral transcription, viral particle production, and host cell infectivity. This targeted neutralization of reactive aldehydes and inhibition of viral expression attenuate pathogen-induced cellular damage and inflammatory signaling, providing clinical relevance for treating respiratory and infectious diseases such as asthma, pneumonia, and viral infection.

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.