Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bradykinin selectively binds to and activates endothelial B2 receptors, triggering a signaling cascade that stimulates the downstream release of prostacyclin, nitric oxide, and endothelium-derived hyperpolarizing factor. This biochemical mediator release induces vascular smooth muscle relaxation and endothelial vasodilation, providing direct physiological relevance to clinical conditions such as hypertension, coronary artery disease, and bradykinin-mediated angioedema.

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.