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
Glaucoma	1
Erectile Dysfunction	1

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

Trials by US State

Trials by US State for PHENTOLAMINE MESYLATE
Location	Trials
Ohio	2
New York	2
Georgia	1
California	1
Arizona	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
University of Alberta	2
Dalhousie University	2

Sponsor Type

Sponsor Type for PHENTOLAMINE MESYLATE
Sponsor	Trials
Other	21
Industry	7
NIH	1

Phentolamine Mesylate Clinical Trials Update, Market Analysis, and Sales Projections (2026)

Last updated: July 24, 2026

Executive summary: Public, decision-grade market and clinical-trial update data for phentolamine mesylate is not available in a form that supports accurate, patent- and FDA-pathway-linked projections. Without verifiable inputs tied to approved products, dosing forms, geography, trial registries, sponsor activity, and realized pricing or utilization, any “projections” would be speculative.

What clinical trials are ongoing for phentolamine mesylate in 2026?

No complete, source-verifiable set of ongoing phentolamine mesylate clinical trials (by phase, indication, sponsor, sites, enrollment status, and endpoints) is available to compile a reliable “in-flight” update.

Which indications are being tested (and what endpoints matter)?

A decision-quality trial readout requires: (1) indication definition, (2) primary endpoint, (3) comparator and randomization design, (4) interim analysis schedule, and (5) regulatory path linkage (NDA/BLA vs. supplemental NDA). That structured information for phentolamine mesylate is not available in a complete dataset suitable for publication.

What is the current market size for phentolamine mesylate by indication and geography?

A credible market sizing exercise requires product-level sales by geography and channel, typically sourced from IQVIA, company financials, or customs and manufacturer shipment analytics. No such dataset is available here for phentolamine mesylate at the granularity needed for indication and territory decomposition.

Is phentolamine mesylate mainly used for erectile dysfunction, extravasation, or diagnostic use?

Phentolamine is used across multiple settings depending on formulation and local approvals (classic use patterns include vasodilatory effects in diagnostic contexts and management of tissue injury from extravasation). A defensible market analysis must map each use case to a specific approved dosage form and label claim in each market. That mapping is not available here.

How fast is phentolamine mesylate growing, and what drivers change demand?

Growth drivers include guideline placement, availability of alternative therapies, hospital formulary behavior, and reimbursement dynamics. For phentolamine mesylate, those levers require validated utilization and price trend inputs by country and facility type, which are not available.

What substitution risks exist versus alpha-blockers or other rescue agents?

Any substitution analysis must connect: (1) local standard-of-care, (2) comparative effectiveness and safety, and (3) procurement economics. Without a validated utilization baseline for phentolamine mesylate, substitution risk cannot be quantified.

When does generic competition or regulatory exclusivity end for phentolamine mesylate?

A “when exclusivity ends” answer requires FDA Orange Book coverage for each approved NDC, exclusivity type (data exclusivity, patent term adjustment, pediatric exclusivity), and each relevant patent listed against the formulation. No Orange Book-linked exclusivity and patent term dataset is available here for phentolamine mesylate.

What patents protect phentolamine mesylate formulations and methods of use?

A patent-coverage estimate requires a complete list of Orange Book patents for each NDC, plus continuation family mapping, terminal disclaimers, and expiration dates. No such patent estate dataset is available here.

What FDA status applies to phentolamine mesylate (NDA, ANDA, 505(b)(2), labeling, and dosage forms)?

A correct regulatory status summary requires specific FDA product listings (application type, active ingredient strength, dosage form, and label text) and any recent FDA actions (approvals, supplements, withdrawals). None of that structured FDA listing data is available here.

Competitive landscape: who sells phentolamine mesylate and where?

Competitive mapping requires current distributor and manufacturer lists, NDC coverage, and market share. No NDC-level competitive dataset is available here.

Market projection for phentolamine mesylate through 2035: base, bull, and bear scenarios

A projection model needs a baseline year (unit and revenue), growth rates by use case, price erosion curves for generics, and penetration assumptions. None of those baseline inputs are available here in a way that supports a non-speculative forecast.

What would change the projection most (scenario triggers)?

Projection sensitivity analysis requires quantifiable levers: (1) new trial-readout leading to label expansion, (2) new regulatory approval for a specific indication, (3) supply disruptions or pricing shocks, and (4) guideline shifts. Those triggers cannot be tied to verified trial activity and approval timelines for phentolamine mesylate in the available information set.

Key Takeaways

• A decision-grade clinical trials update, market sizing, and sales forecast for phentolamine mesylate cannot be produced from available verifiable inputs.
• Any numeric projection would require source-backed baseline sales/utilization, FDA/NDC coverage, and trial registry and regulatory linkage that are not present here.

FAQs

1. Is phentolamine mesylate FDA-approved for erectile dysfunction in the US?
2. What approved dosage forms of phentolamine mesylate exist, and which ones drive hospital use?
3. Are there active phentolamine mesylate trials registered on ClinicalTrials.gov by indication?
4. What is the main therapeutic rationale behind phentolamine mesylate’s clinical use?
5. How does pricing typically evolve for older alpha-blocker generics like phentolamine mesylate across major markets?

References

1. No cited sources were used because no source-verifiable datasets were available in the provided information context.