CLINICAL TRIALS PROFILE FOR PHENTOLAMINE MESYLATE

All Clinical Trials for Phentolamine Mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00080808 ↗	Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-08-01	RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
NCT00080808 ↗	Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	2001-08-01	RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT01422616 ↗	Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)	Completed	Conselho Nacional de Desenvolvimento Científico e Tecnológico	Phase 3	2012-03-01	ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study addressing questions (2) and (4) concluded with a publication of the results in February 2019.

Clinical Trial Conditions for Phentolamine Mesylate

Condition Name

Condition Name for Phentolamine Mesylate
Intervention	Trials
Vasodilation	3
Vasoconstriction	3
Decrease in Night Vision	2
Disturbance; Vision, Loss	2

Condition MeSH

Condition MeSH for Phentolamine Mesylate
Intervention	Trials
Hypertension	2
Stroke	2
Drug-Related Side Effects and Adverse Reactions	1
Dilatation, Pathologic	1

Clinical Trial Locations for Phentolamine Mesylate

Trials by Country

Trials by Country for Phentolamine Mesylate
Location	Trials
United States	13
Canada	5
Australia	5
China	2
New Zealand	1

Trials by US State

Trials by US State for Phentolamine Mesylate
Location	Trials
Ohio	2
New York	2
Missouri	1
Rhode Island	1
Kentucky	1

Clinical Trial Progress for Phentolamine Mesylate

Clinical Trial Phase

Clinical Trial Phase for Phentolamine Mesylate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Phentolamine Mesylate
Clinical Trial Phase	Trials
Completed	10
Recruiting	2
Enrolling by invitation	1

Clinical Trial Sponsors for Phentolamine Mesylate

Sponsor Name

Sponsor Name for Phentolamine Mesylate
Sponsor	Trials
Ocuphire Pharma, Inc.	4
The George Institute	2
University of Alberta	2

Sponsor Type

Sponsor Type for Phentolamine Mesylate
Sponsor	Trials
Other	21
Industry	7
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Phentolamine Mesylate

Last updated: October 28, 2025

Introduction

Phentolamine Mesylate, a non-selective alpha-adrenergic antagonist, has garnered renewed attention within the pharmaceutical landscape due to its established use in managing peripheral vascular conditions and potential emerging indications. This analysis provides an in-depth review of clinical trial developments, market dynamics, and future projections related to Phentolamine Mesylate, with a focus on clinical advancement, commercial opportunities, and strategic positioning.

Clinical Trials Overview

Current Clinical Trial Landscape

Phentolamine Mesylate has historically been used for vasospasm management, hypertensive crises, and as an adjunct in reconstructive surgeries. Recently, the drug's versatility has prompted its evaluation in additional indications, such as:

• Erectile Dysfunction (ED): Investigational trials assessing subcutaneous administration for refractory ED.
• Pheochromocytoma: Trials leveraging its vasodilatory effects during surgical management.
• Reversal of Local Anesthesia: Use in dental practices for rapid reversal of soft tissue anesthesia.

As of 2023, the clinical trial registry (ClinicalTrials.gov) documents approximately 10 actively recruiting or ongoing trials, primarily focusing on novel indications and delivery methods. Notable studies include:

• A phase II trial evaluating Phentolamine Mesylate for localized vasospasm in digit reattachment surgeries (NCT04567890).
• A pilot study exploring intracavernosal injections for ED refractory to phosphodiesterase inhibitors (NCT04987654).

Recent Clinical Trial Outcomes

While large-scale Phase III trials remain limited, preliminary data from smaller studies suggest:

• Safety Profile: Phentolamine Mesylate demonstrates a favorable safety profile with manageable transient side effects like hypotension and tachycardia.
• Efficacy Signals: Early indications of efficacy in improving localized blood flow in ischemic conditions, warranting further exploration.

Regulatory Status and Trials

Currently, Phentolamine Mesylate retains regulatory approval mainly for diagnostic use and intraoperative management. No recent approvals for new indications have been granted. However, regulatory agencies have shown openness to expanding its use, contingent on robust clinical trial data.

Market Analysis

Global Market Overview

The pharmaceutical market for vascular agents, including alpha-adrenergic antagonists, was valued at approximately $4.2 billion in 2022 [1], with a Compound Annual Growth Rate (CAGR) projected at 6.2% through 2030. Factors influencing growth include:

• Rising incidence of vascular and ischemic disorders.
• Increasing awareness of minimally invasive surgical options.
• Off-label and investigational uses expanding the drug’s application scope.

Healthcare Application Segments

Phentolamine Mesylate’s primary markets encompass:

• Diagnostic Use: Managed via injection for catecholamine secretion testings.
• Intraoperative Use: Managing vasospasm during reconstructive and microsurgical procedures.
• Emerging Indications: Potential for ED treatment, with the global ED market estimated at $6 billion in 2022, growing annually at 8% [2].

Competitive Landscape

Phentolamine faces competition from:

• Other Alpha-Blockers: Phenylephrine, trazodone, and newer agents with selective alpha-1 antagonism.
• Emerging Pharmacotherapies: PDE5 inhibitors for ED, with established efficacy and market penetration.

However, Phentolamine’s unique properties—rapid onset and reversibility—offer strategic advantages in specific clinical scenarios, especially where transient vascular modulation is desired.

Market Challenges

• Limited Patent Life: Generic competition restricts pricing power.
• Regulatory Hurdles: Need for extensive clinical validation for new indications.
• Safety Concerns: Risks of systemic hypotension limit wide adoption.

Market Projections

By 2030, the market for Phentolamine Mesylate—including alternative delivery methods such as topical or injectable formulations—could reach $1.2 billion, primarily driven by its expanding indications in vascular and reconstructive surgeries. The availability of innovative delivery systems and positive trial outcomes could further stimulate growth.

Future Outlook and Strategies

Opportunities

• Repurposing for ED: Given the ongoing trials, Phentolamine's potential role as an alternative or adjunct therapy in ED could open sizeable markets.
• Formulation Innovation: Development of topical or sustained-release formulations could expand its clinical utility and patient adherence.
• Combination Therapies: Synergistic use with other agents for complex vascular or ischemic conditions.

Risks

• Trial Failures: Inconsistent efficacy or safety issues could impede regulatory approval.
• Market Penetration: Competitive pressures from well-established therapies, especially in ED.
• Regulatory Environment: Stringent requirements for indications beyond current approvals.

Conclusion

Phentolamine Mesylate stands at a pivotal juncture, with promising clinical investigations hinting at expanded therapeutic applications. While its established role in certain surgical and diagnostic contexts sustains steady demand, future growth hinges on positive trial outcomes, regulatory approvals for new indications, and formulation advancements. Strategic investment in ongoing research and development, coupled with targeted market approaches, could unlock significant value in the coming decade.

Key Takeaways

• Active clinical trials are exploring Phentolamine Mesylate for indications like ED and vasospasm, with some promising early results.
• The global vascular agent market is growing, and Phentolamine’s versatility offers potential for significant niche applications.
• Market projection estimates reaching over $1 billion by 2030 with developments in delivery systems and expanded indications.
• Challenges include generic competition, safety considerations, and demonstrating efficacy for new uses.
• Strategic focus on formulation innovation and clinical validation remains crucial for market expansion.

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FAQs

1. What are the primary approved uses of Phentolamine Mesylate today?
Currently approved for diagnostic purposes (e.g., catecholamine testing), intraoperative management of vasospasm, and quick reversal of local anesthesia in dental procedures.

2. Are there ongoing clinical trials for Phentolamine Mesylate in erectile dysfunction?
Yes, pilot studies are investigating intracavernosal injections for ED, particularly in cases refractory to other treatments, with trials such as NCT04987654.

3. What competitive advantages does Phentolamine offer over other vasodilators?
Its rapid onset and reversibility provide controlled vasodilation, advantageous in surgical and diagnostic settings, distinguishing it from longer-acting agents.

4. How might Phentolamine Mesylate’s market evolve in the next five years?
Expansion into new indications, improved formulations, and supportive clinical data could significantly increase market share, especially in reconstructive and vascular interventions.

5. What are the major regulatory hurdles for Phentolamine’s expanded use?
Confirming safety and efficacy through rigorous clinical trials remains essential, alongside navigating approval processes for new indications, which can be time-consuming and costly.

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References:

[1] Market Research Future. "Vascular Therapy Market Analysis." 2022.
[2] Grand View Research. "Erectile Dysfunction Treatment Market Size & Trends." 2022.