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)
Mechanism and Biochemical Profile
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>).
- 2-Hydroxybenzylamine Solubility in DMSO
- 2-Hydroxybenzylamine Stock Solution
- 2-Hydroxybenzylamine Storage
- 2-Hydroxybenzylamine Stability
- 2-Hydroxybenzylamine Molecular Weight
- 2-Hydroxybenzylamine SMILES
- 2-Hydroxybenzylamine CAS Number
- 2-Hydroxybenzylamine Chemical Structure (2D and 3D)
- 2-Hydroxybenzylamine SDS|MSDS