Clinical Trials

Multiple clinical trials evaluate Tempol across diverse therapeutic indications, including COVID-19, recurrent prostate cancer, cardiovascular parameters, and chemotherapy- or radiation-induced toxicities such as mucositis, nephrotoxicity, ototoxicity, alopecia, and dermatitis. Encompassing Phase 1, Phase 2, and combined Phase 2/3 designs, these studies are sponsored by industry organizations and research institutions, including Matrix Biomed and the National Cancer Institute. Documented recruitment statuses vary, ranging from actively recruiting and completed studies to terminated protocols and single-patient compassionate use programs.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06424756 RECRUITING
Healthy
University of Georgia
 2024-07-01 PHASE2
NCT03480971 RECRUITING
Mucositis; Nephrotoxicity; Ototoxicity
Matrix Biomed, Inc.
 2019-05-13 PHASE2
NCT04729595 TERMINATED
Covid19
Adamis Pharmaceuticals Corporation
 2021-09-01 PHASE2; PHASE3
NCT04876755 UNKNOWN
Prostate Cancer Recurrent; Biochemical Recurrent Prostate Cancer
Matrix Biomed, Inc.
 2021-05-30 PHASE2
NCT04729595 Terminated
Covid19
Adamis Pharmaceuticals Corporation
 2021-09-01 Phase 2|Phase 3
NCT03680404 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
 2018-10-01 PHASE1
NCT03680638 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasodilation
The University of Texas at Arlington
 2016-09-07 PHASE1
NCT01324141 TERMINATED
Anal Cancer
National Cancer Institute (NCI)
 2011-03-18 PHASE1
NCT00801086 UNKNOWN
Alopecia
Mitos Pharmaceuticals
 2008-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2024-12-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tempol acts as a cell-permeable nitroxide antioxidant that directly scavenges superoxide radicals, thereby blunting intracellular reactive oxygen species accumulation and preventing oxidative damage to cellular components. By suppressing oxidative stress-mediated apoptosis and inflammatory signaling cascades, Tempol provides protective cellular effects relevant to clinical trials evaluating radiation- and drug-induced toxicities, prostate cancer, and COVID-19.

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.