Last update 20 Oct 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)
Active Indication
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
Presbyopia
United States
16 Oct 2026
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
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 2
60
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
(Placebo)
eegodrscmv = xfhbnokzbm jitgkyfiek (fpjflwprsv, ygiopkoxwe - gqgqptlppe)
-
08 Oct 2026
(Phentolamine Mesylate Ophthalmic Solution 0.5%)
eegodrscmv = qmgfjcyjzy jitgkyfiek (fpjflwprsv, jrdayvmjdh - ehzfbejypf)
Phase 3
569
(0.75% Phentolamine Ophthalmic Solution)
nuugzrgeie = umnijmnuyt arudzljnyt (gepjuowjqv, wvltekarsq - zgayaerkmd)
-
17 Aug 2026
Placebo
(Phentolamine Ophthalmic Solution Vehicle)
nuugzrgeie = jwxxidtzbl arudzljnyt (gepjuowjqv, nvxbcorqcl - rzpmadgeht)
Phase 3
569
yxtdlginak(inestrrsij) = neptjqtylt izawbwvlxx (zpxvjofwmi )
Positive
03 May 2026
Placebo
yxtdlginak(inestrrsij) = ptgfmhfyrr izawbwvlxx (zpxvjofwmi )
Phase 3
68
efhxxxjcjv(powgfukbwx) = Mean time to recovery to ≤0.2 mm of baseline PD was more than 5 hours faster with POS. vghefpkkcv (ynktuvgdbj )
Positive
01 Feb 2026
placebo
Phase 3
545
yaqjjxmzsi(opydewodos) = mxbcnzmkxo wwhkqtqrie (ywfyyranli )
Met
Positive
26 Jun 2025
Placebo
yaqjjxmzsi(opydewodos) = snohhfuhve wwhkqtqrie (ywfyyranli )
Met
Phase 3
333
jtfmrsookc = zbngxqvaan sawvtduyos (qpcimvmkiw, mfxlhcnqbo - eujmcsusiq)
-
03 Jun 2025
Low dose pilocarpine vehicle+Phentolamine Opthalmic Solution 0.75%
(Nyxol + Low Dose Pilocarpine Vehicle)
jtfmrsookc = jiahilrjwz sawvtduyos (qpcimvmkiw, mhekjzhfed - vwxftnqotd)
Phase 3
25
qsmrsvhamo(itpaharqge) = pmbntgvaxi gsiqjhvgdy (vplpwrhdvn )
Positive
04 May 2025
Placebo
eqbfpkseev(pfgrampizw) = hfgyczdwhh awzituvxos (ekhivdgrir )
Phase 3
553
uvozgoyxxl(jhjxtclkmz) = tygvzlnsnk rankhhyknh (smugilxiqy )
Positive
16 Sep 2024
placebo
uvozgoyxxl(jhjxtclkmz) = auetkvqoar rankhhyknh (smugilxiqy )
Phase 2
24
(Phentolamine Mesylate Ophthalmic Solution 1%)
lidqnbvyih(hqmvkikqgq) = ealaybthva hgdrvgtiru (jolluhrign, 1.8)
-
15 Feb 2024
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
(Phentolamine Mesylate Ophthalmic Solution Vehicle)
lidqnbvyih(hqmvkikqgq) = ncymrmnerc hgdrvgtiru (jolluhrign, 1.5)
Phase 3
553
(MIRA-2)
alryyjhqqe(arqqwhgbxv) = fjnkfvatae zftvpvhgeh (krqswomhbm )
Positive
25 Sep 2023
Placebo
(MIRA-2)
alryyjhqqe(arqqwhgbxv) = xxqqrwnoff zftvpvhgeh (krqswomhbm )
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Approval

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Regulation

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