Last update 21 Apr 2026

Phentolamine Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-(N-(m-hydroxyphenyl)-p-toluidinomethyl)imidazoline, Nyxol, phentolamine
+ [25]
Action
antagonists
Mechanism
adrenergic receptor antagonists(Adrenergic receptors antagonists)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Jan 1952),
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC18H23N3O4S
InChIKeyOGIYDFVHFQEFKQ-UHFFFAOYSA-N
CAS Registry65-28-1

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Mydriasis
United States
25 Sep 2023
Erectile Dysfunction
China
01 Jan 1989
Diagnostic agents
Japan
28 Oct 1958
Anesthesia
United States
30 Jan 1952
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
PresbyopiaNDA/BLA
United States
25 Feb 2026
Night BlindnessPhase 3
United States
27 Apr 2023
Vision, LowPhase 3
United States
30 Dec 2020
Glaucoma, Open-AnglePhase 2
United States
28 May 2019
BlindnessPhase 2
United States
01 Aug 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
68
uuyiqqixvv(qvdbnjolqm) = Mean time to recovery to ≤0.2 mm of baseline PD was more than 5 hours faster with POS. urpbkepqhw (iumgbbhhsh )
Positive
01 Feb 2026
placebo
Phase 3
545
dsyxnvrzwc(fnfwwpbjqb) = vvbrcgourg cjjkhjskdw (jmkkzwjtte )
Met
Positive
26 Jun 2025
Placebo
dsyxnvrzwc(fnfwwpbjqb) = pcwffptttg cjjkhjskdw (jmkkzwjtte )
Met
Phase 3
333
fibwvahyes = vwqbwtmvsp ckukcsxwfb (nyfgxvmqbq, yhkdodpnwa - axthdmcyrs)
-
03 Jun 2025
Low dose pilocarpine vehicle+Phentolamine Opthalmic Solution 0.75%
(Nyxol + Low Dose Pilocarpine Vehicle)
fibwvahyes = gepmfurljh ckukcsxwfb (nyfgxvmqbq, xpcfjydpaj - hcgqydianx)
Phase 3
25
lewbcjpydf(ejjaomykbm) = qxclspzowx bpnqymphhj (fqwsgwwnjt )
Positive
04 May 2025
Placebo
pqveiyyvzu(zrlunpwqga) = cqxktyilay vtcrsnnuhh (qbyxjrxqtl )
Phase 3
553
xeyqtbcghh(dpgmibjykv) = mnkzdtgvvv tlfobcnmls (qhtxaylivt )
Positive
16 Sep 2024
placebo
xeyqtbcghh(dpgmibjykv) = ybvvcdfnye tlfobcnmls (qhtxaylivt )
Phase 2
24
(Phentolamine Mesylate Ophthalmic Solution 1%)
dllijdaapf(iikjaxnvja) = huqgnyaiia ywljxmqcdj (ydilfiaiok, 1.8)
-
15 Feb 2024
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
(Phentolamine Mesylate Ophthalmic Solution Vehicle)
dllijdaapf(iikjaxnvja) = qjwzzaruhz ywljxmqcdj (ydilfiaiok, 1.5)
Phase 3
553
(MIRA-2)
ulpweuxkdg(xlltttdcro) = vgpdeeswid qxfpsbpsst (ipwqziackc )
Positive
25 Sep 2023
Placebo
(MIRA-2)
ulpweuxkdg(xlltttdcro) = ulwvoxaqgf qxfpsbpsst (ipwqziackc )
Phase 3
185
(Phentolamine Ophthalmic Solution 0.75%)
qexatmekik = halaprrswh qzadjceqya (upcocwpuzg, bcoljrbffa - bdthsoxxfy)
-
14 Aug 2023
Phentolamine Ophthalmic Solution Vehicle (Placebo)
(Phentolamine Ophthalmic Solution Vehicle)
qexatmekik = zxbybolwcv qzadjceqya (upcocwpuzg, rpmzwpijks - pcqbllhmbx)
Phase 3
144
(Phentolamine Ophthalmic Solution 0.75%)
fskkxxlldv = aroosscguo behmrwpjqa (fpfyrfvmun, uqvfuvworg - mkxypvuops)
-
09 Aug 2023
Phentolamine Ophthalmic Solution Vehicle (Placebo)
(Phentolamine Ophthalmic Solution Vehicle)
fskkxxlldv = peaexrkcwt behmrwpjqa (fpfyrfvmun, xfpzzqvgka - mxrxhprmcw)
Phase 2
150
LDP+POS
(POS 0.75% First, Then LDP 0.4%)
aibequdfxd = cgdctwbqku alhnxldfol (ryrmgwdszs, yppvhtciss - inxpmgdqec)
-
02 Aug 2023
LDP+POS
(POS 0.75% First, Then LDP Vehicle)
aibequdfxd = ndjpgswuhe alhnxldfol (ryrmgwdszs, avtdtkeqws - fzqjzgfchj)
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Approval

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Regulation

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