ORAVERSE (phentolamine mesylate)
OraVerse is used for adults and children aged three and older to reverse the effects of dental numbing agents. It helps patients with lingering anesthesia of the lip and tongue, as well as the functional issues that follow a local anesthetic injection. This medication is specifically used when the original anesthetic contained a vasoconstrictor.
How ORAVERSE Works
This medication works by blocking alpha-adrenergic receptors, which leads to the widening of blood vessels in the local tissue. This vasodilation increases blood flow to the area where the anesthetic was injected. By increasing local circulation, the drug helps accelerate the reversal of soft-tissue numbness and restores normal sensation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-05-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ORAVERSE Approval History
What ORAVERSE Treats
2 indicationsORAVERSE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Soft-tissue anesthesia of the lip and tongue
- Functional deficits following local dental anesthesia
ORAVERSE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT05448807 | 71192 | Ph 3 | recruiting | Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT02995291 | 2016-4014 | Ph 4 | completed | Reversing the Effects of 0.5% Bupivacaine |
| NCT01474382 | PHE-11-001 | Ph 4 | completed | Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ORAVERSE FDA Label Details
Indications & Usage
FDA Label (PDF)ORAVERSE is indicated for the treatment of Soft-tissue anesthesia of the lip and tongue; Functional deficits following local dental anesthesia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment