TheraRadar
Data updated: May 26, 2026

PHENTOLAMINE MESYLATE

Cardiovascular Approved 1998-03-11

PHENTOLAMINE MESYLATE is indicated for the treatment of Hypertension; Pheochromocytoma; Dermal Necrosis.

Source: FDA Label • PRECISION DOSE INC
2
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1998-03-11
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PHENTOLAMINE MESYLATE

PHENTOLAMINE MESYLATE Approval History

1999
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Original
New Indication
New Form
Label Update
2 FDA actions from 1998 to 2017
Jul 2017 ORIGINAL
Update
Mar 1998 ORIGINAL
Update

What PHENTOLAMINE MESYLATE Treats

3 indications

PHENTOLAMINE MESYLATE is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Pheochromocytoma
  • Dermal Necrosis
Source: FDA Label

PHENTOLAMINE MESYLATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PHENTOLAMINE MESYLATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
2 shared
Aurobindo Pharma
Shared indications:
PheochromocytomaHypertension
ACEBUTOLOL HYDROCHLORIDE
ACEBUTOLOL HYDROCHLORIDE
1 shared
PHARMOBEDIENT
Shared indications:
ADREVIEW
IOBENGUANE SULFATE I-123
1 shared
GE HEALTHCARE
Shared indications:
Pheochromocytoma
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PHENTOLAMINE MESYLATE FDA Label Details

Indications & Usage

PHENTOLAMINE MESYLATE is indicated for the treatment of Hypertension; Pheochromocytoma; Dermal Necrosis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.