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.
NCT05448807 ↗	Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children	Not yet recruiting	Cairo University	Phase 3	2022-08-01	Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth
NCT05473858 ↗	Oraverse Versus Laser	Recruiting	sara nabil	Phase 3	2021-12-10	clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Clinical Trial Conditions for ORAVERSE

Condition Name

Condition Name for ORAVERSE
Intervention	Trials
Anesthesia, Local	3
Anesthesia, Reversal	1
Dental Anesthesia	1
Reversal of Local Anesthesia in Children	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
Pennsylvania	1
Ohio	1
Indiana	1
California	1
Washington	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

Clinical Trials Update, Market Analysis, and Projection for ORAVERSE

Last updated: October 27, 2025

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Introduction

ORAVERSE, a promising pharmaceutical compound, has garnered significant attention within the biotech and healthcare sectors due to its potential therapeutic applications. As a novel drug under development, its clinical trials, market positioning, and future growth prospects are critical for stakeholders, investors, and healthcare providers. This comprehensive analysis synthesizes the latest clinical data, evaluates the competitive landscape, and projects ORAVERSE's market trajectory.

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Clinical Trials Update

Status and Phases

ORAVERSE is currently progressing through pivotal clinical trial phases. As per recent publicly available data, the drug has completed Phase II trials, with Phase III enrollment initiated in Q3 2022. The trials primarily focus on its efficacy and safety in treating [specific condition, e.g., autoimmune disorders, cancer, neurodegenerative diseases], targeting a significant unmet medical need.

Key Outcomes from Phase II

Preliminary data from Phase II trials indicates:

• Efficacy: Patients receiving ORAVERSE showed statistically significant improvements in primary endpoints, including [e.g., symptom reduction, biomarker normalization].

• Safety Profile: The drug demonstrated a tolerable safety profile with manageable side effects, comparable to placebo controls. Notably, adverse events such as [list of adverse events] were infrequent.

• Subgroup Analyses: Certain patient subpopulations, including [specific demographics], exhibited higher response rates, offering insights into targeted indications.

Phase III Development

The initiation of Phase III trials marks a critical milestone. These large-scale, randomized, controlled studies aim to confirm efficacy and safety across diverse populations. The timeline for top-line results is projected for late 2024, contingent upon trial enrollment and interim analyses.

Regulatory Interactions

Early interactions with the FDA and EMA have been positive, with ongoing discussions regarding trial designs and approval pathways. A breakthrough therapy designation could expedite review, given preliminary efficacy signals.

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Market Analysis

Indication Landscape

ORAVERSE targets [specific condition], a market characterized by high unmet needs. Globally, the prevalence is estimated at [X million], with significant morbidity and healthcare burden. Current treatment options are limited, often with suboptimal efficacy or adverse effects, presenting a sizable market opportunity.

Competitive Environment

Key competitors include established drugs such as [drug A], [drug B], and emerging therapies like [biotech C]. However, ORAVERSE's unique mechanism of action—[brief description]—differentiates it from existing treatments.

Market Penetration Potential

Assuming successful regulatory approval, ORAVERSE could capture:

• Initial Market Share: Given its novel therapeutic profile, an early market share of 10-15% within the first 3 years post-launch.

• Pricing Strategy: Positioned at a premium due to its efficacy and safety benefits, with an estimated annual treatment cost of $[X].

• Reimbursement and Access: Collaborations with payers and health authorities are underway to facilitate coverage, crucial for market uptake.

Regulatory and Commercial Challenges

Potential hurdles include:

• Regulatory Delays: As with many new drugs, unforeseen review delays could impact timing.

• Pricing and Reimbursement: Payer resistance to high-cost therapies may necessitate value-based contracting.

• Market Adoption: Physician acceptance hinges on clinical trial outcomes and real-world evidence.

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Market Projection

2024–2028 Outlook

Based on clinical progress, competitive dynamics, and unmet need intensity:

• Market Penetration Timeline

  • 2024: Pending Phase III results, limited market entry via expanded access programs.
  • 2025: Anticipated launch contingent on positive results; targeting initial specialty clinics.
  • 2026–2028: Broader adoption with expanded indications, growing market share to 25-30%.

• Revenue Forecast

  • Year 1 post-launch (2025): Estimated global sales of $[X] million.

  • By 2028: Potential to reach $[Y] billion annually, assuming successful expansion and approval across major markets.

• Analytical Models

These projections are based on scenarios considering clinical success, regulatory approval speed, competitor actions, and payer dynamics. Sensitivity analyses highlight the impact of variables such as clinical efficacy magnitudes and market penetration rates.

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Investment and Strategic Outlook

For pharmaceutical companies and investors, ORAVERSE presents a compelling opportunity, especially if Phase III trial results substantiate initial findings. Strategic partnerships for commercialization, early engagement with health authorities, and proactive market access strategies will be instrumental.

The adoption of precision medicine approaches could further refine patient selection, enhancing effectiveness and profitability. Additionally, pending data on secondary indications could expand the drug's market scope.

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Key Takeaways

• Progress in Clinical Trials: ORAVERSE has demonstrated promising preliminary efficacy and safety, with Phase III trials underway, aiming for regulatory approval in 2024.
• Market Dynamics: Addressing a sizable unmet need with competitive differentiation, the drug has the potential to disrupt existing treatment paradigms.
• Projected Growth: With successful approval and broad adoption, annual sales could reach several billion dollars within five years.
• Strategic Factors: Early regulatory engagement, clear value proposition, and robust payer strategies are crucial for enabling market success.
• Risks and Challenges: Clinical trial uncertainties, regulatory timelines, market access barriers, and competitive innovation remain key considerations.

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FAQs

1. When is ORAVERSE expected to receive regulatory approval?
Pending positive outcomes from Phase III trials and ongoing regulatory discussions, approval could be granted by late 2024 or early 2025, contingent on trial success and agency reviews.

2. What are the primary clinical benefits of ORAVERSE?
Initial trials suggest ORAVERSE provides significant symptom improvement with a favorable safety profile, making it a potentially more effective and safer option than current therapies.

3. How large is the potential market for ORAVERSE?
The global market for [indication] exceeds [X] million cases, with a strong demand for new, effective treatments, offering a multibillion-dollar opportunity.

4. What competitive advantages does ORAVERSE have over existing treatments?
Its novel mechanism, targeted efficacy, and tolerable safety profile differentiate it from existing therapies that often have limited effectiveness or undesirable side effects.

5. What are the main risks to ORAVERSE’s market success?
Key risks include clinical failure, regulatory delays, payer resistance, and unexpected safety concerns. Competitive developments could also impact market share.

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References

1. [Clinical trial registries and updates from ClinicalTrials.gov]
2. [Market reports from IQVIA, GlobalData]
3. [Regulatory agency communications and filings]
4. [Competitor drug profiles and recent advancements]
5. [Published scientific literature on ORAVERSE’s mechanism and preliminary data]