Clinical Trials

Multiple clinical trials evaluate pimonidazole across various solid malignancies, including pancreatic, colorectal, prostate, melanoma, and head and neck cancers, as well as non-oncologic conditions such as thoracic aortic aneurysms and refractory pulmonary tuberculosis. Spearheaded by prominent academic medical centers and public research organizations, these Early Phase 1 to Phase 2 studies and diagnostic protocols encompass completed, recruiting, active not recruiting, suspended, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03418818 ACTIVE_NOT_RECRUITING
Sarcoma
University Health Network, Toronto
 2018-03-27
NCT02095249 ACTIVE_NOT_RECRUITING
Prostate Cancer
University Health Network, Toronto
 2014-09
NCT06085781 RECRUITING
Squamous Cell Carcinoma of Head and Neck
University Health Network, Toronto
 2024-01-29
NCT03410420 COMPLETED
Aortic Aneurysm, Thoracic
Thomas Gleason
 2018-09-01 PHASE1
NCT03181035 SUSPENDED
Tongue Cancer
Sunnybrook Health Sciences Centre
 2018-01-25 PHASE1; PHASE2
NCT02414048 UNKNOWN
Head and Neck Cancer
Marius Gustav Bredell
 2015-04 PHASE2
NCT03718650 WITHDRAWN
Pancreatic Cancer; Resectable Pancreatic Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2021-04-01 EARLY_PHASE1
NCT03718650 Withdrawn
Pancreatic Cancer|Resectable Pancreatic Cancer
H. Lee Moffitt Cancer Center and Research Institute|Varian Medical Systems
 2021-04-01 Early Phase 1
NCT03410420 Suspended
Aortic Aneurysm Thoracic
University of Maryland Baltimore
 2018-10-01 Phase 1
NCT03262311 Completed
Cancer
Institute of Cancer Research United Kingdom
 2017-11-10 Not Applicable
NCT02157246 COMPLETED
Hypoxia in Rectal Cancer
University of Oxford
 2013-10
NCT01992042 COMPLETED
Prostate Cancer
University Health Network, Toronto
 2014-02 PHASE2
NCT02624115 Completed
Colon Rectal Cancer Adenocarcinoma
University Health Network Toronto
 2016-05-01 --
NCT02061007 WITHDRAWN
Melanoma; Skin Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2014-10 PHASE2
NCT02095249 Active not recruiting
Prostate Cancer
University Health Network Toronto
 2014-09 Not Applicable
NCT00374517 WITHDRAWN
Refractory Pulmonary Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-09-05 PHASE2
NCT00374517 Withdrawn
Refractory Pulmonary Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)|International Tuberculosis Research Center|National Institutes of Health Clinical Center (CC)
 2006-09-05 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pimonidazole undergoes bioreductive activation by cellular nitroreductases specifically under hypoxic conditions, forming covalent adducts with thiol-containing macromolecules in oxygen-deprived cells. This intracellular entrapment selectively labels tissue areas lacking adequate oxygen supply, enabling the quantitative assessment of tumor hypoxia relevant to treatment resistance in clinical conditions such as pancreatic, prostate, and head and neck cancers.

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.