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and university medical centers, these investigations span completed, actively recruiting, and terminated or withdrawn protocols assessing preoperative alpha-adrenergic blockade and pediatric parenteral applications.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| NCT00770705 | WITHDRAWN | Congenital Heart Disease |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| NCT00770705 | Withdrawn | Congenital Heart Disease |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)
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>).
- Phenoxybenzamine HCl Solubility in DMSO
- Phenoxybenzamine HCl Stock Solution
- Phenoxybenzamine HCl Storage
- Phenoxybenzamine HCl Stability
- Phenoxybenzamine HCl Molecular Weight
- Phenoxybenzamine HCl SMILES
- Phenoxybenzamine HCl CAS Number
- Phenoxybenzamine HCl Chemical Structure (2D and 3D)
- Phenoxybenzamine HCl SDS|MSDS