MedPath

Phentolamine

Generic Name
Phentolamine
Brand Names
Oraverse
Drug Type
Small Molecule
Chemical Formula
C17H19N3O
CAS Number
50-60-2
Unique Ingredient Identifier
Z468598HBV
Background

Phentolamine is a reversible, non-selective alpha-adrenergic blocker that induces vasodilation. While initially introduced to the market for the treatment of hypertension, this clinical use was halted due to cardiovascular and gastrointestinal adverse effects with the prolonged use of large oral doses of phentolamine. It has several therapeutic uses, including the treatment of hypertensive episodes, prevention of norepinephrine-induced extravasation, diagnosis of pheochromocytoma, reversal of soft-tissue anesthesia, and treatment of pharmacologically-induced mydriasis. Phentolamine is administered intravenously, intramuscularly, submucosally, and topically.

Indication

1.用于预防和治疗嗜铬细胞瘤所致的高血压发作,包括手术切除时出现的阵发性高血压,也可根据血压对本品的反应用于协助诊断嗜铬细胞瘤;

2.治疗左心衰竭;

3.治疗去甲肾上腺素、去氧肾上腺素、间羟胺等静脉给药外溢,用于防止皮肤坏死;

4.临床还用于治疗男性勃起功能障碍(ED)。最新研究表明,本品与罂粟碱、前列地尔三联用药,可降低引起平滑肌收缩的交感神经张力,使阴茎动脉平滑肌松弛,增加阴茎动脉血流,有利勃起。

Associated Conditions
Mydriasis, Necrosis caused by norepinephrine extravasation, Pheochromocytoma, Sloughing Skin, Soft Tissue Anesthesia (Numbness), Hypertensive episodes

Sex Differences in Sympathetic Vascular Reactivity at High Altitude

Not Applicable
Completed
Conditions
Vasodilation
Vasoconstriction
Interventions
Other: Isometric Handgrip and Post-Exercise Circulatory Occlusion
Other: Rhythmic Handgrip
Other: Cold Pressor Test
First Posted Date
2022-09-01
Last Posted Date
2023-03-23
Lead Sponsor
University of Alberta
Target Recruit Count
17
Registration Number
NCT05525416
Locations
🇨🇦

University of Alberta, Edmonton, Alberta, Canada

🇨🇦

University of British Columbia - Okanagan, Kelowna, British Columbia, Canada

Oraverse Versus Laser

Phase 3
Conditions
Reversal of Local Anesthesia in Children
Interventions
First Posted Date
2022-07-26
Last Posted Date
2022-07-26
Lead Sponsor
sara nabil
Target Recruit Count
40
Registration Number
NCT05473858
Locations
🇪🇬

Dr.sara nabil, Cairo, Egypt

Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children

Phase 3
Not yet recruiting
Conditions
Soft Tissue Injuries
Interventions
First Posted Date
2022-07-07
Last Posted Date
2022-10-03
Lead Sponsor
Cairo University
Target Recruit Count
80
Registration Number
NCT05448807

Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

First Posted Date
2022-02-04
Last Posted Date
2023-09-05
Lead Sponsor
Ocuphire Pharma, Inc.
Target Recruit Count
23
Registration Number
NCT05223478
Locations
🇺🇸

Clinical Site 2, Athens, Ohio, United States

🇺🇸

Clinical Site 1, Longwood, Florida, United States

Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

Early Phase 1
Recruiting
Conditions
Obesity
Vasodilation
Healthy
Interventions
First Posted Date
2022-02-02
Last Posted Date
2025-03-28
Lead Sponsor
University of Missouri-Columbia
Target Recruit Count
72
Registration Number
NCT05219799
Locations
🇺🇸

University of Missouri, Columbia, Missouri, United States

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

First Posted Date
2021-11-26
Last Posted Date
2023-08-29
Lead Sponsor
Ocuphire Pharma, Inc.
Target Recruit Count
368
Registration Number
NCT05134974
Locations
🇺🇸

Clinical Site 5, Pittsburg, Kansas, United States

🇺🇸

Clinical Site 10, Newport Beach, California, United States

🇺🇸

Clinical Site 9, Delray Beach, Florida, United States

and more 12 locations

Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

Phase 2
Completed
Conditions
Presbyopia
Interventions
First Posted Date
2020-12-19
Last Posted Date
2023-09-07
Lead Sponsor
Ocuphire Pharma, Inc.
Target Recruit Count
150
Registration Number
NCT04675151
Locations
🇺🇸

Clinical Site 18, Saint Louis, Missouri, United States

🇺🇸

Clinical Site 12, Laguna Hills, California, United States

🇺🇸

Clinical Site 3, Pittsburg, Kansas, United States

and more 14 locations

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

Phase 3
Completed
Conditions
Dim Light Vision Disturbances
Interventions
First Posted Date
2020-11-20
Last Posted Date
2023-09-08
Lead Sponsor
Ocuphire Pharma, Inc.
Target Recruit Count
144
Registration Number
NCT04638660
Locations
🇺🇸

Clinical Site 13, Pittsburg, Kansas, United States

🇺🇸

Clinical Site 1, Petaluma, California, United States

🇺🇸

Clinical Site 19, Ogden, Utah, United States

and more 14 locations

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

Phase 3
Completed
Conditions
Mydriasis
Dilation
Interventions
Other: Phentolamine Ophthalmic Solution Vehicle (Placebo)
First Posted Date
2020-11-06
Last Posted Date
2023-09-11
Lead Sponsor
Ocuphire Pharma, Inc.
Target Recruit Count
185
Registration Number
NCT04620213
Locations
🇺🇸

Clinical Site 7, Pittsburg, Kansas, United States

🇺🇸

Clinical Site 3, Shawnee Mission, Kansas, United States

🇺🇸

Clinical Site 11, Newport Beach, California, United States

and more 9 locations

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Early Phase 1
Recruiting
Conditions
Healthy
Vasoconstriction
Vasodilation
Obesity
Interventions
First Posted Date
2020-06-18
Last Posted Date
2024-05-03
Lead Sponsor
University of Missouri-Columbia
Target Recruit Count
104
Registration Number
NCT04436731
Locations
🇺🇸

University of Missouri-Columbia, Columbia, Missouri, United States

© Copyright 2025. All Rights Reserved by MedPath