Clinical Trials

Multiple clinical trials evaluate Phenoxybenzamine HCl across Phase 2, Phase 3, and Phase 4 development for conditions such as pheochromocytoma, paraganglioma, congenital heart disease, and perioperative management during cardiac surgery. Sponsored predominantly by academic institutions and university medical centers, these investigations span completed, actively recruiting, and terminated or withdrawn protocols assessing preoperative alpha-adrenergic blockade and pediatric parenteral applications. Overall, these studies focus on evaluating hemodynamic stability and the comparative efficacy of adrenoceptor inhibition in surgical settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05702944 RECRUITING
Pheochromocytoma; Paraganglioma; Adrenalectomy; Status; Adrenergics Causing Adverse Effects in Therapeutic Use
Seoul National University Hospital
2023-01-18 PHASE4
NCT03176693 COMPLETED
Pheochromocytoma; Paraganglioma
University of California, Los Angeles
2017-05-05 PHASE3
NCT01379898 COMPLETED
Pheochromocytoma
University Medical Center Groningen
2011-12 PHASE4
NCT01379898 Completed
Pheochromocytoma
University Medical Center Groningen|Radboud University Medical Center|UMC Utrecht|VU University of Amsterdam|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|Leiden University Medical Center|Erasmus Medical Center|Maastricht University Medical Center|St. Antonius Hospital|Medisch Spectrum Twente|Maxima Medical Center|Canisius-Wilhelmina Hospital|Onze Lieve Vrouwe Gasthuis|Atrium Medical Center|Isala
2011-12 Phase 4
NCT00770705 WITHDRAWN
Congenital Heart Disease
Vanderbilt University
2008-10 PHASE2
NCT00569855 COMPLETED
Open-heart Surgery; Cardiopulmonary Bypass
University of Arkansas
2001-02 PHASE2
NCT00620945 TERMINATED
Congenital Heart Surgery; Cardiopulmonary Bypass
The Cleveland Clinic
2006-06
NCT00770705 Withdrawn
Congenital Heart Disease
Vanderbilt University|Vanderbilt University Medical Center
2008-10 Phase 2

(data from https://clinicaltrials.gov, updated on 2025-06-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenoxybenzamine HCl acts as a non-specific, irreversible alpha-adrenergic antagonist by forming permanent covalent bonds with alpha adrenoceptors, thereby blocking endogenous catecholamines such as adrenaline and noradrenaline from binding. This receptor blockade inhibits vascular smooth muscle constriction to induce pronounced vasodilation, directly addressing hypertension and restoring hemodynamic balance in clinical settings such as pheochromocytoma and perioperative surgical management.

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.