Clinical Trials

Several early-phase clinical trials—primarily completed Phase 1 and Phase 2 studies sponsored by academic and commercial entities—have evaluated apocynin. These studies have addressed cardiovascular conditions involving vasoconstriction and vasodilation, as well as inflammatory and respiratory disorders such as bronchial asthma, chronic obstructive pulmonary disease, and knee osteoarthritis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04657926 COMPLETED
Osteoarthritis
AKL Research and Development
 2020-09-09 PHASE2
NCT03680404 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
 2018-10-01 PHASE1
NCT03680573 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction
The University of Texas at Arlington
 2018-01-08 PHASE1
NCT03680638 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Vasodilation
The University of Texas at Arlington
 2016-09-07 PHASE1
NCT01402297 COMPLETED
Chronic Obstructive Pulmonary Disease
Medical University of Lodz
 2010-10 PHASE1
NCT00992667 COMPLETED
Bronchial Asthma
Medical University of Lodz
 2008-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2021-11-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apocynin acts as a selective inhibitor of NADPH-oxidase with an IC50 of 10 μM, blocking the enzymatic assembly required for intracellular reactive oxygen species generation. By reducing oxidative stress and downstream pro-inflammatory signaling, this inhibition mitigates tissue injury, offering therapeutic potential in cardiovascular diseases, pulmonary inflammatory disorders, and osteoarthritis.

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.