Clinical Trials

Numerous clinical trials evaluate phentolamine mesylate across various development phases, spanning Early Phase 1 to Phase 4, with statuses including completed, actively recruiting, and not yet recruiting. Sponsored by academic medical centers and commercial entities, these investigations target conditions such as night vision disturbances, severe pre-eclampsia, congestive heart failure, and soft tissue trauma following local anesthesia. Notable studies assess specific formulations, including ophthalmic solutions for dim light vision impairment and intravenous administration for pre-eclampsia management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07726433 RECRUITING
Chemotherapy-Induced Nausea and Vomiting (CINV)
Tianjin Medical University Cancer Institute and Hospital
 2026-06-15 PHASE2
NCT05997732 RECRUITING
Vasoconstriction; Vasodilation
University of Alberta
 2023-10-31 PHASE4
NCT05219799 RECRUITING
Obesity; Vasodilation; Healthy
University of Missouri-Columbia
 2023-03-14 EARLY_PHASE1
NCT06787066 RECRUITING
Menopause
University of Missouri-Columbia
 2025-07-10 EARLY_PHASE1
NCT03318094 ACTIVE_NOT_RECRUITING
Insulin Resistance; Healthy; Obesity
Vanderbilt University Medical Center
 2017-10-24 PHASE1
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT07140783 ACTIVE_NOT_RECRUITING
Vision Loss Night; Vision Disorders
Ocuphire Pharma, Inc.
 2025-09-02 PHASE3
NCT05448807 RECRUITING
Soft Tissue Injuries
Cairo University
 2025-07-05 PHASE3
NCT06385600 UNKNOWN
Severe Pre-eclampsia
Assiut University
 2024-05-20
NCT07012512 NOT_YET_RECRUITING
Pupillary Constriction; Accomodation
Mansoura University
 2025-06-01
NCT06422494 COMPLETED
Diabetes Mellitus, Type 1; Inflammation
Radboud University Medical Center
 2025-09-28
NCT06349759 COMPLETED
Mesopic Vision; Night Vision Loss
Ocuphire Pharma, Inc.
 2024-04-01 PHASE3
NCT06542497 COMPLETED
Presbyopia
Ocuphire Pharma, Inc.
 2024-08-15 PHASE3
NCT06620991 NOT_YET_RECRUITING
Preoperative; Phentolamine; Intraoperative; Esmolol; Hypotensive Anesthesia; Functional Endoscopic Sinus Surgery
Ain Shams University
 2024-10-10
NCT06286059 UNKNOWN
CA-AKI - Contrast-Associated Acute Kidney Injury; Coronary Artery Disease; Acute Coronary Syndrome; Adrenergic Receptor Antagonist Adverse Reaction
Helwan University
 2024-03-07 PHASE2; PHASE3
NCT06385600 Not yet recruiting
Severe Pre-eclampsia
Assiut University
 2024-05-20 Not Applicable
NCT06172998 UNKNOWN
Obstructive Sleep Apnea
Xu J
 2022-04-01 EARLY_PHASE1
NCT05646719 COMPLETED
Presbyopia
Ocuphire Pharma, Inc.
 2022-12-22 PHASE3
NCT05687669 COMPLETED
Pre-Eclampsia; Complicating Pregnancy; Pre-eclampsia Aggravated
Assiut University
 2023-01-12 PHASE4
NCT05525416 COMPLETED
Vasodilation; Vasoconstriction
University of Alberta
 2022-07-28
NCT04638660 COMPLETED
Dim Light Vision Disturbances
Ocuphire Pharma, Inc.
 2020-12-30 PHASE3
NCT05223478 COMPLETED
Mydriasis; Dilation
Ocuphire Pharma, Inc.
 2021-12-17 PHASE3
NCT05134974 COMPLETED
Mydriasis; Dilation
Ocuphire Pharma, Inc.
 2021-11-18 PHASE3
NCT04955236 Completed
Posterior Fossa Tumor
Kasr El Aini Hospital
 2021-07-14 Phase 1
NCT04675151 COMPLETED
Presbyopia
Ocuphire Pharma, Inc.
 2021-02-15 PHASE2
NCT04620213 COMPLETED
Mydriasis; Dilation
Ocuphire Pharma, Inc.
 2020-11-18 PHASE3
NCT04269980 UNKNOWN
Mean Blood Pressure
Beni-Suef University
 2020-04-01
NCT03098680 TERMINATED
Drug-Related Side Effects and Adverse Reactions; Cardiovascular System Disease
Cambridge University Hospitals NHS Foundation Trust
 2017-04-24 PHASE1
NCT04110808 UNKNOWN
Effect of Drugs
Beni-Suef University
 2019-10-15 EARLY_PHASE1
NCT04024891 COMPLETED
Mydriasis; Dilation
Ocuphire Pharma, Inc.
 2019-08-13 PHASE2
NCT03960866 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Ocuphire Pharma, Inc.
 2019-05-28 PHASE2
NCT03079921 COMPLETED
Type1diabetes; Hypoglycemia; Hypoglycemia Unawareness; Islet Cell Transplantation
University of Pennsylvania
 2017-01-20 EARLY_PHASE1
NCT03740386 COMPLETED
Anesthesia, Local
León Formación
 2016-01-01
NCT02861378 COMPLETED
Soft Tissue Anaesthesia
Dalhousie University
 2015-10
NCT01703559 COMPLETED
Night Vision Complaints; Decrease in Night Vision; Disturbance; Vision, Loss
Ocuphire Pharma, Inc.
 2011-09-09 PHASE2
NCT04004507 COMPLETED
Decrease in Night Vision; Disturbance; Vision, Loss
Ocuphire Pharma, Inc.
 2007-08 PHASE2
NCT00226096 COMPLETED
CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages
The George Institute
 2005-11
NCT00080808 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 2001-08 PHASE2
NCT00154167 COMPLETED
Soft Tissue Anesthesia (Numbness)
Novalar Pharmaceuticals, Inc.
 2003-02 PHASE2
NCT00309335 COMPLETED
Anesthesia, Dental
Novalar Pharmaceuticals, Inc.
 2006-02 PHASE3
NCT00309361 COMPLETED
Anesthesia, Dental
Novalar Pharmaceuticals, Inc.
 2006-02 PHASE3
NCT00309322 COMPLETED
Anesthesia, Dental
Novalar Pharmaceuticals, Inc.
 2006-03 PHASE2
NCT00132106 UNKNOWN
Heart Failure, Congestive
Radboud University Medical Center
 2005-08

(data from https://clinicaltrials.gov, updated on 2026-07-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phentolamine mesylate acts as a reversible, non-selective alpha-adrenergic receptor antagonist, blocking norepinephrine-induced intracellular calcium signaling and preventing vascular smooth muscle contraction. The resulting vasodilation and tissue relaxation directly underlie its therapeutic utility in managing hypertensive crises such as severe pre-eclampsia, reversing local anesthesia, and alleviating dim light vision disturbances.

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.