Clinical Trials

Hydralazine hydrochloride is evaluated across numerous clinical trials ranging from early Phase 1 through Phase 4, focusing primarily on cardiovascular indications including essential hypertension, preeclampsia with severe features, congestive heart failure, and intracerebral hemorrhage. Sponsored by government organizations, academic medical centers, and industry leaders such as the National Heart, Lung, and Blood Institute, Stanford University, and Daiichi Sankyo, these protocols display varied recruitment statuses, including active, recruiting, completed, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04842552 COMPLETED
Alzheimer Disease
Shahid Sadoughi University of Medical Sciences and Health Services
 2021-08-02 PHASE3
NCT06218199 RECRUITING
Heart Failure, Congestive
Heart Center Research, LLC
 2021-07-08 PHASE4
NCT03514108 COMPLETED
Heart Failure; Diabetes
Henrik Wiggers
 2018-03-01 PHASE4
NCT05230901 UNKNOWN
Aortic Stenosis, Severe
University Medical Center Goettingen
 2022-02-23 PHASE3
NCT06360601 UNKNOWN
Preeclampsia Severe
Tanta University
 2024-04-01 PHASE1; PHASE2
NCT07572656 COMPLETED
Preeclampsia
Muhammad Aamir Latif
 2024-05-01
NCT04484350 COMPLETED
Stroke, Acute; Vessels; Occlusion; Blood Pressure; Endovascular Thrombectomy; Mechanical Thrombectomy
Hamilton Health Sciences Corporation
 2020-10-23 PHASE2
NCT04217135 UNKNOWN
Systolic Heart Failure Stage D (Disorder); Mitral Regurgitation
Kaohsiung Veterans General Hospital.
 2017-01-01 PHASE4
NCT04116112 COMPLETED
Acute Stroke; Endovascular Thrombectomy
University of Cincinnati
 2020-01-17 PHASE2
NCT05096728 Completed
Preeclampsia With Severe Features
Ohio State University
 2021-12-01 --
NCT02281838 TERMINATED
Intracerebral Hemorrhage
University of Alberta
 2011-08-01 PHASE2
NCT04164004 Active not recruiting
Heart Failure
Stanford University
 2021-08-30 Not Applicable
NCT03423810 COMPLETED
Polycystic Kidney Diseases
University of Kansas Medical Center
 2018-04-23 EARLY_PHASE1
NCT02046395 COMPLETED
Type 2 Diabetes; Hypertension
Tulane University School of Medicine
 2012-01 PHASE4
NCT02228408 COMPLETED
Chronic Hemodialysis (ESRD)
Brigham and Women's Hospital
 2017-08-28 PHASE4
NCT04435210 COMPLETED
Hypertension
Adebayo Joshua Adeniyi
 2018-08-13
NCT02446652 WITHDRAWN
Cervical Cancer
National Institute of Cancerología
 2015-01-01 PHASE3
NCT03619317 Unknown status
Cancer of Esophagus
Aarhus University Hospital Skejby|Danish Cancer Society
 2018-06-25 --
NCT00223717 COMPLETED
Hypertension
Vanderbilt University
 2001-01 PHASE1
NCT02933593 WITHDRAWN
Hypertension
St. Louis University
 2016-08
NCT01516346 COMPLETED
Heart Failure; Congestive Heart Failure
Corporal Michael J. Crescenz VA Medical Center
 2012-01 PHASE2
NCT01822808 UNKNOWN
Acute Heart Failure; Left Ventricular Dysfunction
University of Cape Town
 2013-01 PHASE3
NCT02343393 UNKNOWN
Cardio-Renal Syndrome
National University Hospital, Singapore
 2015-01 PHASE3
NCT02050529 COMPLETED
Hypertension, Pregnancy Induced; Hydralazine Adverse Reaction; Pre-eclampsia; Pre-eclampsia Superimposed Pre-existing Hypertension
Dow University of Health Sciences
 2012-10 PHASE2
NCT01356875 UNKNOWN
Myelodysplastic Syndrome
Basque Health Service
 2011-09 PHASE2
NCT01538875 COMPLETED
Hypertension, Pregnancy Induced
Saint Thomas Hospital, Panama
 2012-07 PHASE3
NCT00996060 COMPLETED
Lung Cancer
New Mexico Cancer Research Alliance
 2008-07 PHASE1
NCT01255475 COMPLETED
Heart Failure; Cardiac Failure; Congestive Heart Failure
University of Sao Paulo
 2011-01 PHASE2; PHASE3
NCT01587313 COMPLETED
Healthy
Arbor Pharmaceuticals, Inc.
 2012-04 PHASE1
NCT01587313 Completed
Healthy
Arbor Pharmaceuticals Inc.
 2012-04 Phase 1
NCT00963976 COMPLETED
Intracerebral Hemorrhage
University of Alberta
 2007-01 PHASE2
NCT00532818 UNKNOWN
Metastatic Cervical Cancer
National Institute of Cancerología
 2007-07 PHASE3
NCT00575978 WITHDRAWN
Breast Cancer
University of Arkansas
 2004-06 PHASE1; PHASE2
NCT00661895 COMPLETED
Hypertension
Creighton University
 2005-08 PHASE4
NCT00607477 TERMINATED
Treatment Induced Hypertension
University of Chicago
 2008-01
NCT00599235 COMPLETED
Hypertension
University of Edinburgh
 2007-03
NCT00575640 WITHDRAWN
Rectal Cancer
University of Arkansas
 2004-11 PHASE1; PHASE2
NCT00311974 COMPLETED
Healthy
Regional Hospital Holstebro
 2006-04 PHASE4
NCT00226096 COMPLETED
CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages
The George Institute
 2005-11
NCT00204984 COMPLETED
High Blood Pressure
University of Wisconsin, Madison
 2005-05
NCT00772499 COMPLETED
Hypertension
Daiichi Sankyo
 2002-11 PHASE4
NCT00000499 COMPLETED
Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1980-09 PHASE2
NCT00533299 UNKNOWN
Ovarian Cancer
National Institute of Cancerología
 2007-08 PHASE3
NCT00395655 TERMINATED
Locally Advanced Breast Cancer
National Institute of Cancerología
 2005-06 PHASE2
NCT00404326 COMPLETED
Cervical Cancer
National Institute of Cancerología
 2005-05 PHASE2
NCT00404508 COMPLETED
Refractory Solid Tumors
National Institute of Cancerología
 2005-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydralazine hydrochloride acts as a direct vascular smooth muscle relaxant and nitric oxide donor that elevates intracellular cyclic guanosine monophosphate levels, thereby suppressing inositol trisphosphate-mediated sarcoplasmic calcium release. This molecular cascade inhibits arterial constriction and reduces peripheral vascular resistance, providing the physiological basis for lowering blood pressure in clinical conditions such as hypertension, preeclampsia, and heart failure.

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>).

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Note: Technical data last updated: Sep 1, 2026.