Clinical Trials

Multiple clinical trials are evaluating 2-hydroxybenzylamine in Phase I and Phase II studies targeting cardiovascular, metabolic, and age-related conditions, including familial hypercholesterolemia, catheter ablation-associated atrial fibrillation, salt sensitivity of blood pressure, and cognitive decline. Sponsored by academic institutions, medical centers, and biotechnology companies with federal support, these protocols range from completed safety and brain-penetrance assessments in healthy volunteers to active, recruiting, and planned interventions in target patient cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07602166 NOT_YET_RECRUITING
Salt Sensitivity of Blood Pressure; High Blood Pressure; Inflammation; Renin-Angiotensin-Aldosterone System
Vanderbilt University Medical Center
2026-09 PHASE2
NCT06432166 NOT_YET_RECRUITING
Alzheimer Disease; Mild Cognitive Impairment
MTI Biotech Inc
2026-09-01 PHASE1; PHASE2
NCT04941599 RECRUITING
Familial Hypercholesterolemia
Vanderbilt University Medical Center
2024-02-14 PHASE2
NCT07419633 RECRUITING
Muscle; Cognitive Functioning; Geriatric; Ageing and Geriatric Health; Ageing
McGill University Health Centre/Research Institute of the McGill University Health Centre
2026-03-06
NCT04941599 Recruiting
Familial Hypercholesterolemia
Vanderbilt University Medical Center|National Heart Lung and Blood Institute (NHLBI)
2024-02-14 Phase 2
NCT04433091 COMPLETED
Atrial Fibrillation
Vanderbilt University Medical Center
2020-05-15 PHASE2
NCT03556319 COMPLETED
Older Adults
Metabolic Technologies Inc.
2018-05-23
NCT04433091 Active not recruiting
Atrial Fibrillation
Vanderbilt University Medical Center|American Heart Association
2020-05-15 Phase 2
NCT03555682 COMPLETED
Healthy Volunteers
Metabolic Technologies Inc.
2018-05-23
NCT03554096 COMPLETED
Healthy Adults
Metabolic Technologies Inc.
2018-05-23
NCT03176940 COMPLETED
Healthy Volunteers
Metabolic Technologies Inc.
2017-08-02

(data from https://clinicaltrials.gov, updated on 2026-07-28)

Check the 2-Hydroxybenzylamine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Hydroxybenzylamine acts as a selective scavenger of dicarbonyl electrophiles such as isolevuglandins, rapidly reacting with these species to prevent the destructive covalent modification of key cellular proteins and lipids. By neutralizing these oxidative intermediates, the compound suppresses downstream inflammatory cascades and lipid peroxidation, thereby enhancing efferocytosis and vascular tissue stability in clinical conditions such as familial hypercholesterolemia and hypertension.

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.