Numerous clinical trials evaluate BQ-123 across various cardiovascular, metabolic, and renal conditions, including coronary artery disease, hypertension, myocardial reperfusion injury, chronic kidney disease, and type 1 diabetes. Spanning early phase 1 through phase 4, these studies are sponsored by academic and clinical research institutions such as the Medical University of Vienna, Mayo Clinic, and the University of Edinburgh. Across the trial portfolio, recruitment statuses encompass completed, actively recruiting, unknown, and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02966665 | RECRUITING | Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension |
Russell Richardson |
2008-09 | PHASE1 |
| NCT03679780 | COMPLETED | Cardiovascular Diseases; Cardiovascular Risk Factor; Vasoconstriction |
The University of Texas at Arlington |
2018-10-01 | PHASE1 |
| NCT04907838 | UNKNOWN | Type2 Diabetes |
University of Southern Denmark |
2018-05-01 | |
| NCT01119417 | WITHDRAWN | Hypertension; Pure Autonomic Failure; Multiple System Atrophy |
Vanderbilt University |
2010-05 | PHASE1 |
| NCT04449198 | Recruiting | Type 1 Diabetes |
Augusta University |
2020-10-14 | Early Phase 1 |
| NCT02062346 | COMPLETED | Vasculitis |
University of Edinburgh |
2016-08 | |
| NCT02124824 | COMPLETED | Heart Failure |
VA Office of Research and Development |
2014-09-01 | EARLY_PHASE1 |
| NCT01395329 | COMPLETED | Prehypertension; Hypertension |
University of Colorado, Boulder |
2011-05 | PHASE4 |
| NCT01658410 | UNKNOWN | Coronary Artery Disease; Aorto-coronary Bypass Grafting |
Medical University of Vienna |
2012-07 | PHASE2 |
| NCT02086253 | COMPLETED | Healthy Conditions |
University Hospital, Rouen |
2014-02 | |
| NCT00586820 | COMPLETED | Myocardial Reperfusion Injury |
Mayo Clinic |
2005-05 | PHASE2 |
| NCT00915070 | COMPLETED | Healthy |
Medical University of Vienna |
2010-10 | |
| NCT00759408 | COMPLETED | Pulmonary Hypertension |
Brigham and Women's Hospital |
1999-02 | PHASE2 |
| NCT00502528 | COMPLETED | ST-Elevation Myocardial Infarction |
Medical University of Vienna |
2007-05 | PHASE2 |
| NCT00745693 | COMPLETED | Coronary Disease |
University of Edinburgh |
2008-03 | |
| NCT00745693 | Completed | Coronary Disease |
University of Edinburgh|Umeå University |
2008-03 | Not Applicable |
| NCT00722215 | COMPLETED | Chronic Kidney Disease; Proteinuria |
University of Edinburgh |
2006-05 | PHASE1 |
| NCT00115583 | COMPLETED | Atherosclerosis, Coronary |
Brigham and Women's Hospital |
1998-11 | |
| NCT00427232 | COMPLETED | Coronary Vessels; Endothelins; Vascular Resistance |
Medical University of Vienna |
2003-05 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2025-09-26)
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>).