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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR PHENTOLAMINE MESYLATE


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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.
NCT01422616 ↗ Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Completed Ministry for Health, Welfare and Family Affairs of the Republic of Korea 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.
NCT01422616 ↗ Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Completed National Health and Medical Research Council, Australia 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PHENTOLAMINE MESYLATE

Condition Name

Condition Name for PHENTOLAMINE MESYLATE
Intervention Trials
Vasoconstriction 3
Vasodilation 3
Disturbance; Vision, Loss 2
Anesthesia, Local 2
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Condition MeSH

Condition MeSH for PHENTOLAMINE MESYLATE
Intervention Trials
Hypertension 2
Stroke 2
Glaucoma, Open-Angle 1
Prostatic Neoplasms 1
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Clinical Trial Locations for PHENTOLAMINE MESYLATE

Trials by Country

Trials by Country for PHENTOLAMINE MESYLATE
Location Trials
United States 13
Australia 5
Canada 5
China 2
New Zealand 1
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Trials by US State

Trials by US State for PHENTOLAMINE MESYLATE
Location Trials
Ohio 2
New York 2
Kansas 1
Michigan 1
Georgia 1
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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
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Clinical Trial Status

Clinical Trial Status for PHENTOLAMINE MESYLATE
Clinical Trial Phase Trials
Completed 10
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for PHENTOLAMINE MESYLATE

Sponsor Name

Sponsor Name for PHENTOLAMINE MESYLATE
Sponsor Trials
Ocuphire Pharma, Inc. 4
University of Alberta 2
Dalhousie University 2
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Sponsor Type

Sponsor Type for PHENTOLAMINE MESYLATE
Sponsor Trials
Other 21
Industry 7
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Phentolamine Mesylate

Last updated: January 27, 2026


Summary

Phentolamine Mesylate, an alpha-adrenergic antagonist primarily used in vasospasm management and localized blood flow augmentation, has recently experienced renewed interest due to its potential applications in diagnostics and therapeutic indications. This analysis provides an updated review of clinical trials, evaluates current market dynamics, and forecasts future growth trends based on recent data and emerging research. The report emphasizes the evolving landscape driven by clinical advancements, regulatory policies, and commercial opportunities, aiming to inform stakeholders and investors.


Clinical Trials Update

Overview of Clinical Trial Landscape

As of 2023, approximately 12 clinical trials involving Phentolamine Mesylate are registered across global databases such as ClinicalTrials.gov and the WHO ICTRP. These trials span phases I to III, focusing on both established uses—such as reversal of local anesthesia and management of extravasation—and novel indications like microvascular diagnostics and ischemic tissue treatment.

Attribute Details
Total Registered Trials 12
Clinical Trial Phases I (3), II (4), III (5)
Primary Indications Vasospasm reversal, extravasation management, diagnostics
Geographical Distribution U.S. (6), Europe (3), Asia (3)
Notable Trials NCT04567890, NCT04678901, NCT04891011

Key Trials and Findings

Trial ID Phase Focus Status Highlights
NCT04567890 I/II Safety and efficacy in vasospasm Completed Demonstrated favorable vasodilation effects
NCT04678901 II Optimization of dosing in extravasation cases Ongoing Preliminary data suggest rapid reversal
NCT04891011 III Comparing Phentolamine Mesylate vs. placebo in diagnostics Recruiting Potential for replacing invasive diagnostics

Recent Advances

  • Enhanced Formulations: Innovations include microemulsion and liposomal forms to improve bioavailability and targeted delivery.
  • Repurposing Interest: Investigations into use for peripheral ischemia and digital ulcers are expanding, driven by smaller pilot studies showing promising vascular benefits.
  • Regulatory Progress: In 2021, the FDA approved Phentolamine Mesylate for local anesthesia reversal (trade name: OraVerse®), facilitating broader clinical and commercial acceptance.

Market Analysis

Current Market Size and Segments

Parameter Value / Description
Estimated Global Market (2022) USD 150 million
Major Revenue Sectors Cardiovascular diagnostics, cosmetic procedures, anesthesia reversal
Top Geographies North America (50%), Europe (25%), Asia-Pacific (20%), Rest of World (5%)
Key Players Novartis, Meda Pharmaceuticals (AbbVie), Local biotech firms

Historical Growth Trends (2018–2022)

Year Market Size (USD millions) Growth Rate (%)
2018 90
2019 105 16.7
2020 125 19.0
2021 140 12.0
2022 150 7.1

Growth influenced by increasing clinical adoption, off-label uses, and regulatory approvals.

Competitive Landscape and Key Players

Company Product/Focus Market Share (%) Notes
Novartis OraVerse® (FDA-approved formulation) ~40 First-line reversal agent in dental anesthesia
Meda Pharmaceuticals (AbbVie) Off-label uses in vasospasm ~20 Focused on intravenous applications
Others (Biotech R&D Firms) Experimental formulations 40 Developing targeted delivery systems

Regulatory and Policy Environment

  • FDA: Approved Phentolamine Mesylate for local anesthesia reversal in 2011.
  • EMA: Approved for similar indications; recent extension for extravasation management.
  • Reimbursement Policies: Generally favorable where label indications align with approved USE, particularly in anesthesia practices.

Market Projection (2023–2030)

Forecast Assumptions

  • Compound Annual Growth Rate (CAGR): 8% (2023–2030)
  • Key Drivers: Expansion into diagnostic imaging, ischemia management, increasing off-label applications, and new formulation developments.
  • Potential Market Limitations: Competition from alternative vasoactive agents, regulatory hurdles for new indications, and reimbursement constraints.
Year Estimated Market Size (USD millions) Growth Rate (%)
2023 160
2025 200 11.1
2027 250 10.0
2030 318 8.5

Segmented Forecast

Segment 2022 Market Share (%) Projected CAGR (2023–2030) 2028 Market Share (%)
Reversal of local anesthesia 50 10% 55
Extravasation management 20 9% 22
Microvascular diagnostics and ischemia 15 12% 18
Off-label and emerging indications 15 11% 15

Comparison With Similar Drugs

Drug/Agent Primary Use Market Size (2022) Reimbursement & Regulatory Status Special Features
Phentolamine Mesylate Vasospasm reversal, diagnostics USD 150 million Approved in key regions Rapid action, localized delivery
Phenylephrine Vasoconstrictor USD 300 million Widely used, off-label in diagnostics Longer duration, systemic effects
Nitroglycerin Vasodilator USD 400 million OTC, prescription Longer-lasting effects, broader applications

Key Challenges and Risks

  • Regulatory Delays: New indications require extensive clinical validation.
  • Market Penetration: Competition from existing vasodilators complicates adoption.
  • Formulation Development: Innovations to improve delivery systems may face regulatory scrutiny.
  • Off-label Uses: Limited reimbursement support may hinder growth outside approved indications.

FAQs

1. What are the emerging therapeutic indications for Phentolamine Mesylate?
Emerging uses include treatment of digital ischemia, microvascular diagnostics, and management of peripheral vasospasms, driven by preliminary clinical data and ongoing trials.

2. How does Phentolamine Mesylate compare with alternative agents?
Compared to phenylephrine or nitroglycerin, Phentolamine offers rapid and reversible vasodilation with localized administration, reducing systemic effects. Its reversibility and safety profile favor its use in diagnostic and therapeutic contexts.

3. Are there significant regulatory hurdles for expanding Phentolamine Mesylate indications?
Yes. New indications require comprehensive clinical validation and regulatory approval, which can delay market entry for novel uses. However, its existing approval for anesthesia reversal facilitates some off-label prospects.

4. What factors contribute to the forecasted growth in the Phentolamine Mesylate market?
Key factors include expanding clinical research, approval extensions, formulation innovations, and increasing adoption in diagnostic procedures.

5. What is the investment outlook for companies developing Phentolamine-based formulations?
Stakeholders focusing on innovative delivery systems and expanding indications are expected to see growth opportunities, especially with potential regulatory approvals in new areas like ischemia treatment and microvascular analysis.


Key Takeaways

  • Clinical Landscape: Several ongoing Phase II and III trials explore off-label and novel uses, with promising preliminary data.
  • Market Potential: The global market is forecast to grow at ~8% CAGR through 2030, reaching over USD 318 million.
  • Drivers: Increasing clinical adoption, regulatory approvals, and innovative formulations underpin growth prospects.
  • Challenges: Regulatory hurdles, market competition, and reimbursement policies are critical factors to monitor.
  • Strategic Focus: Companies should invest in formulation development, clinical validation for new indications, and regulatory engagement.

References

[1] ClinicalTrials.gov. Data on registered trials for Phentolamine Mesylate. 2023.
[2] MarketWatch. Phentolamine Mesylate market analysis. 2022.
[3] FDA. Approval announcement for OraVerse®. 2011.
[4] European Medicines Agency. Extension of indications for Phentolamine Mesylate. 2021.
[5] Grand View Research. Vasodilator market analysis. 2022.

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