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Phentolamine · Oraverse, Regitine

Small molecule · Antagonist of alpha-1 adrenergic receptor and alpha-2 adrenergic receptor · developed by Novartis

Approved FDA, Jan 1952
6 Registered trials

What is Phentolamine?

Phentolamine is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist that reversibly binds alpha-1 receptors on the iris dilator muscle, reducing pupil diameter. It is studied in night vision disturbances, presbyopia and mesopic vision problems, and is labeled for reversing pharmacologically induced mydriasis and soft-tissue anesthesia of the lip and tongue after intraoral local anesthetic injection.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Oraverse, Regitine, Ryzumvi
Drug type
Small molecule
Targets
alpha-1 adrenergic receptor, alpha-2 adrenergic receptor
Mechanism
Antagonist of alpha-1 adrenergic receptor and alpha-2 adrenergic receptor
Pathways
adrenergic signaling, iris dilator muscle contraction, pupil dilation
Therapy area
Ophthalmology
Developer
Novartis
In trials of
IRD
FDA status
Approved as Oraverse, Regitine, Ryzumvi (January 30, 1952), NDA008278 · FDA label
UNII
Z468598HBV

✅ FDA-approved uses

From the indications section of the FDA label (version of Mar 15, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07140783 Phase 3 Vision Loss Night Recruiting IRD
NCT06349759 Phase 3 Mesopic Vision Completed IRD
NCT05646719 Phase 3 Presbyopia Completed IRD
NCT04638660 Phase 3 Dim Light Vision Disturbances Completed IRD
NCT01703559 Phase 2 Night Vision Complaints Completed IRD
NCT04004507 Phase 2 Decrease in Night Vision Completed IRD

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Vision DisordersVision Loss NightDecrease in Night VisionDim Light Vision DisturbancesDisturbance; Vision, LossMesopic VisionNight Vision ComplaintsNight Vision LossPresbyopia

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.