Numerous clinical trials evaluate bradykinin's role in vascular regulation and associated pathologies, spanning Phase 1 to Phase 4 alongside observational protocols. These studies investigate conditions including hereditary and ACE inhibitor-induced angioedema, acute ischemic stroke, hypertension, coronary artery disease, and critical illness, examining parameters such as pharmacokinetic safety and enzymatic degradation pathways. Sponsored by academic institutions, university hospital networks, and biopharmaceutical enterprises, these trials exhibit varied statuses ranging from actively recruiting and completed to terminated or unassigned.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05834777 | RECRUITING | Intradialytic Hypotension |
Vanderbilt University Medical Center |
2023-12-11 | PHASE3 |
| NCT07046806 | RECRUITING | Hereditary Angioedema (HAE); Angioedema; Bradykinin-mediated Angioedema; C1 Inhibitor Deficiency |
Institute for Asthma and Allergy |
2025-03-10 | PHASE1; PHASE2 |
| NCT07290855 | COMPLETED | Bradykinin-mediated Angioedema; Hereditary Angioedema (HAE) |
Nang Kuang Pharmaceutical Co., Ltd. |
2024-09-27 | PHASE4 |
| NCT03738878 | TERMINATED | Hypertension |
Vanderbilt University Medical Center |
2018-11-15 | PHASE4 |
| NCT06109142 | Not yet recruiting | Critically Ill Patients |
Assistance Publique - Hôpitaux de Paris |
2024-04-01 | -- |
| NCT06210698 | Not yet recruiting | Angioedema|Angioedemas Hereditary|Urticaria|Mastocytosis|ACE Inhibitor-Induced Angioedema|C1 Inhibitor Deficiency|Systemic Mastocytoses|Indolent Systemic Mastocytosis |
Foundation For Rare Disease Research|Institute for Asthma & Allergy|Virant Diagnostics Inc.|MedBio Reference Laboratories Inc. |
2024-01-15 | -- |
| NCT06380699 | Completed | Acute Ischemic Stroke |
Changzhou Qianhong Bio-pharma Co. Ltd. |
2023-03-16 | Phase 1 |
| NCT05304091 | Unknown status | Bradykinin-mediated Angioedema |
University Hospital Lille |
2022-08 | -- |
| NCT04763577 | Recruiting | Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor |
University Hospital Grenoble|University Hospital Paris|University Hospital Rouen |
2021-10-27 | -- |
| NCT05010876 | COMPLETED | Covid19 |
GCS Ramsay Santé pour l'Enseignement et la Recherche |
2021-02-04 | PHASE2 |
| NCT01595516 | COMPLETED | Prehypertension; Hypertension |
University of Colorado, Boulder |
2012-02 | PHASE4 |
| NCT01574248 | TERMINATED | ACE Inhibitor-associated Angioedema |
Vanderbilt University Medical Center |
2011-08 | PHASE4 |
| NCT02189122 | COMPLETED | Healthy |
Vanderbilt University |
2014-07 | |
| NCT01413542 | COMPLETED | Hypertension; Diabetes Type 2 |
Vanderbilt University |
2011-11 | |
| NCT01036659 | UNKNOWN | Angioedema |
Bernstein, Jonathan A., M.D. |
2010-05 | PHASE2 |
| NCT00166166 | TERMINATED | Hyperlipidemia |
Emory University |
2002-07 | PHASE2 |
| NCT00223704 | COMPLETED | Cardiopulmonary Bypass; Inflammation; Fibrinolysis; Surgery |
Vanderbilt University |
2006-05 | PHASE2; PHASE3 |
| NCT00517582 | TERMINATED | Angioneurotic Edema |
Vanderbilt University |
2007-09 | PHASE1 |
| NCT00780481 | TERMINATED | Obesity |
Vanderbilt University |
2007-01 | |
| NCT00780377 | WITHDRAWN | Heart Transplantation |
Vanderbilt University |
2008-10 | |
| NCT00780637 | WITHDRAWN | Heart Transplantation |
Vanderbilt University |
2008-10 | |
| NCT00868855 | TERMINATED | Coronary Artery Disease |
Vanderbilt University |
2003-12 | PHASE1 |
| NCT00965393 | COMPLETED | Ischaemic Heart Diseases |
University of Edinburgh |
2009-08 | |
| NCT00965120 | COMPLETED | Ischaemic Heart Diseases |
University of Edinburgh |
2009-08 | |
| NCT00685945 | COMPLETED | Obesity |
Vanderbilt University |
2007-12 | |
| NCT00176345 | UNKNOWN | Coronary Artery Disease |
University of Leipzig |
2001-01 | PHASE2 |
| NCT00004575 | COMPLETED | Healthy |
National Heart, Lung, and Blood Institute (NHLBI) |
2000-02 | PHASE1 |
| NCT00160888 | UNKNOWN | Healthy |
Heidelberg University |
1999-11 | PHASE1 |
| NCT00083356 | COMPLETED | Tooth, Impacted |
National Institute of Nursing Research (NINR) |
2004-05 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-04-15)
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>).