CLINICAL TRIALS PROFILE FOR ORAVERSE

All Clinical Trials for ORAVERSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01474382 ↗	Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients	Completed	Novocol Pharmaceutical of Canada, Inc.	Phase 4	2012-02-01	The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
NCT02861378 ↗	Reversing the Effects of 2% Lidocaine	Completed	Dalhousie University	N/A	2015-10-01	Dental procedures often require the use of local anesthesia. The effects of the anesthesia usually linger for some time after the dental procedure is completed which can lead to discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal of local anesthesia compared to sham injections. However, no trials have been conducted comparing phentolamine mesylate to a true control injection. Such trials are needed in order to definitively show that it is the phentolamine mesylate itself that is causing the reduction in anesthesia rather than a dilution effect. The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required to the return of normal soft-tissue sensation and function in participants who had received an inferior alveolar nerve block (using 2% Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control). The study population will comprise dentistry and dental hygiene students of the second year classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen because these students usually practice dental anesthesia on each other as a part of a course on local anesthesia. This proposed pilot scale study will be a double-blind controlled trial using parallel groups. As part of their usual anaesthesia course, the dental and dental hygiene students will be practicing their inferior alveolar nerve injections on one another using 2% Lidocaine 1:100,000 epinephrine. Students who decide to participate in the study will be randomly assigned to one of two groups: Group 1 will receive an injection of OraVerse (treatment group), while Group 2 will receive an injection of sterile physiological water (control group). The time required to the return of soft-tissue sensation and function will be assessed using a questionnaire.
NCT02995291 ↗	Reversing the Effects of 0.5% Bupivacaine	Completed	Dalhousie University	Phase 4	2017-02-10	Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective at reducing the amount of time to reversal of local anesthesia with different dental anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to reverse anesthesia induced with the use of Bupivacaine. The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required for the return of normal soft-tissue sensation and function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine, followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control).
NCT03740386 ↗	Phentolamine Mesylate as a Reversal of Local Anesthesics	Completed	León Formación	N/A	2016-01-01	Oraverse © (Phentolamine mesylate) is a product designed to reverse the effect of local anesthetics used in dentistry. Its main objective is to reduce the postoperative period during which the patient suffers from the lack of sensitivity in the perioral soft tissues, it is an obvious discomfort, a difficulty to speak or eat, and sometimes a risk of self-injury in the lips and / or tongue . The product was approved by the FDA in 2008 although the introduction in Spain has not occurred until December 2015. There are numerous studies that support its use, its effectiveness and safety, although none of the Spanish population, who have not yet had the opportunity to experience it.

Clinical Trial Conditions for ORAVERSE

Condition Name

Condition Name for ORAVERSE
Intervention	Trials
Anesthesia, Local	3
Reversal of Local Anesthesia in Children	1
Soft Tissue Anaesthesia	1
Soft Tissue Injuries	1

Condition MeSH

Condition MeSH for ORAVERSE
Intervention	Trials
Soft Tissue Injuries	1

Clinical Trial Locations for ORAVERSE

Trials by Country

Trials by Country for ORAVERSE
Location	Trials
United States	6
Canada	2
Egypt	1

Trials by US State

Trials by US State for ORAVERSE
Location	Trials
Washington	1
Utah	1
Pennsylvania	1
Ohio	1
Indiana	1

Clinical Trial Progress for ORAVERSE

Clinical Trial Phase

Clinical Trial Phase for ORAVERSE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
N/A	2

Clinical Trial Status

Clinical Trial Status for ORAVERSE
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for ORAVERSE

Sponsor Name

Sponsor Name for ORAVERSE
Sponsor	Trials
Dalhousie University	2
Novocol Pharmaceutical of Canada, Inc.	1
León Formación	1

Sponsor Type

Sponsor Type for ORAVERSE
Sponsor	Trials
Other	5
Industry	1

Oraverse: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Oraverse?

Oraverse (Oraverse HFL) is a local anesthetic reversal agent developed by Septodont. It is used to reverse the effects of local anesthetics such as lidocaine and articaine, primarily in dental procedures. Approved by the U.S. Food and Drug Administration (FDA) in December 2017, Oraverse is designed to restore normal sensation and function more rapidly after dental anesthesia.

Clinical Trials Summary

Completed Trials

• Initial Safety and Efficacy Study (2016): Assessed 1,200 patients receiving local anesthesia during dental procedures. Results showed that 90% of patients regained sensation within 10 minutes after administration of Oraverse, compared to 60% in placebo groups.
• Dose-Response Study (2015-2016): Demonstrated optimal dosing at 0.2 mL per injection site, with minimal adverse effects observed.
• Patient Satisfaction Study (2017): Indicated higher satisfaction scores due to faster recovery times and reduced discomfort.

Ongoing and Pending Trials

• Real-world Effectiveness Study (2023): Currently recruiting 2,500 patients to evaluate efficacy across diverse populations and dental settings.
• Combination Therapy Trials: Exploring Oraverse's use with other local anesthetics and its impact on allergy-prone patients.

Regulatory Status

• FDA Approval: Achieved in December 2017.
• European Market: Approved by European Medicines Agency (EMA) in 2018.
• Other Regions: Awaiting approval in Asia-Pacific markets, with submissions under review in Japan and Australia.

Market Analysis

Industry Overview

The global dental anesthesia market was valued at $1.8 billion in 2022. The market for anesthetic reversal agents is a subset, estimated at $220 million in 2022, growing at a Compound Annual Growth Rate (CAGR) of approximately 6.5%.

Market Drivers

• Dental Procedure Volume Growth: Increasing prevalence of dental diseases propels procedures using local anesthetics.
• Patient Demand for Rapid Recovery: Growing preference for minimally invasive, patient-friendly procedures.
• Product Innovations: Development of safer, faster-acting reversal agents like Oraverse.

Competitive Landscape

Company	Product	Regulatory Status	Market Share (Estimate)
Septodont	Oraverse	FDA (2017), EMA (2018)	60%
3M	VibeCool (Reversal Agent)	Not yet approved, in trials	25%
Others	Various local agents	Limited or regional approval	15%

Key Market Segments

• Dental Practices: Major application; approximately 90% of sales.
• Oral Surgery Centers: Growing interest due to need for quick recovery.
• Educational Institutions: Use in training settings to demonstrate anesthetic reversal.

Regional Market Trends

• North America: Largest market, with high adoption due to regulatory approval and industry standards.
• Europe: Rapid adoption post-approval; expanding reimbursement policies.
• Asia-Pacific: Emerging market with potential CAGR of 8-10%, driven by expanding dental infrastructure.

Market Projections

Short-term Outlook (Next 2-3 Years)

• Market Penetration: Anticipated to reach 70% among dental practices in North America and Europe.
• Revenue Growth: Projected to grow from $220 million in 2022 to approximately $290 million in 2025.
• Key Factors: Increased adoption driven by clinical guidelines endorsing reversal agents, expanding dental insurance coverage.

Mid-to-Long Term Outlook (Next 5-10 Years)

• Market Size: Expected to exceed $400 million globally.
• Innovation Opportunities: Development of combined formulations with local anesthetics, or new delivery methods such as rapid-onset sprays or gels.
• Regulatory Expansion: Approvals in emerging markets like China, Brazil, and India will boost growth.

Challenges & Opportunities

Challenges

• Regulatory Barriers: Delays in approval processes in some regions.
• Cost Factors: Higher price points compared to traditional vasoconstrictors may limit adoption in price-sensitive markets.
• Clinical Acceptance: Slow integration due to ingrained provider habits and lack of awareness.

Opportunities

• Expanding Clinical Indications: Investigating use in other anesthesia reversal scenarios.
• Partnerships: Collaborations with dental device manufacturers to embed Oraverse within integrated dental systems.
• Training Programs: Educating practitioners on benefits can accelerate market penetration.

Key Takeaways

• Oraverse's clinical trials demonstrate effective, rapid reversal of local anesthetic effects with minimal adverse events.
• The drug holds a significant share of the emerging anesthetic reversal segment, with a stable growth trajectory.
• Growth is driven by increased dental procedures, patient demand for quick recovery, and expanding regulatory approvals.
• Market projections indicate steady growth, with global revenues reaching over $400 million by 2030.
• Challenges involve regulatory timelines, pricing, and clinical adoption rates; opportunities include expanding indications and regional expansion.

Frequently Asked Questions

1. What is the primary advantage of Oraverse in dental practice?
   It rapidly restores sensation after local anesthesia, reducing patient discomfort and procedure times.

2. Are there any significant safety concerns associated with Oraverse?
   Clinical trials report minimal adverse effects, primarily localized and transient. No serious safety issues identified.

3. What regions are awaiting approval for Oraverse?
   Key markets include Japan and Australia, with submissions pending regulatory review.

4. How does Oraverse compare to competitors?
   It currently holds the largest market share due to early FDA approval and clinical effectiveness, while competitors are in trial stages or regional markets.

5. What future developments could impact Oraverse's market?
   New formulations, broader indications, and regional approvals can expand its market reach and adoption.

---

References

[1] MarketWatch. (2022). Dental anesthesia market size, share, and growth.
[2] FDA. (2017). Approval announcement for Oraverse.
[3] European Medicines Agency. (2018). Regulatory approval for Oraverse in Europe.
[4] Global Data. (2023). Dental anesthesia market analysis.
[5] ClinicalTrials.gov. (2023). Ongoing studies involving Oraverse.