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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR MEPIVACAINE HYDROCHLORIDE


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All Clinical Trials for MEPIVACAINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00121329 ↗ 4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions Completed Oregon Health and Science University N/A 1969-12-31 Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine) to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy and office hysteroscopy. Local anesthetic injected into the uterine cavity has been demonstrated effective in some studies at decreasing patient pain associated with these intrauterine procedures at an anesthetic concentration of at least 2%. Based on this evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain during first trimester abortions.
NCT00154167 ↗ Safety and Efficacy Study of NV-101 in Dental Patients Completed Novalar Pharmaceuticals, Inc. Phase 2 2003-02-01 The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT00567450 ↗ Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block Completed Centre Hospitalier Universitaire, Amiens Phase 4 2007-09-01 In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest. This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.
NCT00803725 ↗ Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Completed University Health Network, Toronto N/A 2008-08-01 The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade. It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.
NCT00825786 ↗ Ultrasound Guided Supraclavicular Nerve Block Completed The Cleveland Clinic Phase 3 2008-09-01 This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
NCT00841841 ↗ Dipyrone Versus Acetaminophen in the Control of Postoperative Pain Completed University of Sao Paulo Phase 2 2006-03-01 Adequate postoperative pain management is challenging for practitioners despite recent advances in pain control techniques and analgesic agents. The purpose of this study is to compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar surgery.
NCT00841841 ↗ Dipyrone Versus Acetaminophen in the Control of Postoperative Pain Completed University Center of Araraquara Phase 2 2006-03-01 Adequate postoperative pain management is challenging for practitioners despite recent advances in pain control techniques and analgesic agents. The purpose of this study is to compare the efficacy of Dipyrone and acetaminophen in postoperative pain after third molar surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MEPIVACAINE HYDROCHLORIDE

Condition Name

Condition Name for MEPIVACAINE HYDROCHLORIDE
Intervention Trials
Symptomatic Irreversible Pulpitis 8
Pain 7
Anesthesia 5
Postoperative Pain 4
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Condition MeSH

Condition MeSH for MEPIVACAINE HYDROCHLORIDE
Intervention Trials
Pulpitis 14
Pain, Postoperative 12
Osteoarthritis, Knee 3
Hypertension 3
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Clinical Trial Locations for MEPIVACAINE HYDROCHLORIDE

Trials by Country

Trials by Country for MEPIVACAINE HYDROCHLORIDE
Location Trials
United States 25
Egypt 10
Brazil 7
Italy 4
Spain 4
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Trials by US State

Trials by US State for MEPIVACAINE HYDROCHLORIDE
Location Trials
New York 3
Massachusetts 2
Minnesota 2
North Carolina 2
Tennessee 2
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Clinical Trial Progress for MEPIVACAINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MEPIVACAINE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE4 4
PHASE3 2
Phase 4 31
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Clinical Trial Status

Clinical Trial Status for MEPIVACAINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 54
Not yet recruiting 11
Recruiting 10
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Clinical Trial Sponsors for MEPIVACAINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for MEPIVACAINE HYDROCHLORIDE
Sponsor Trials
Cairo University 12
University of Sao Paulo 4
Hospital for Special Surgery, New York 3
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Sponsor Type

Sponsor Type for MEPIVACAINE HYDROCHLORIDE
Sponsor Trials
Other 109
Industry 3
U.S. Fed 1
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Mepivacaine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Mepivacaine Hydrochloride, a local anesthetic agent preferred for infiltration and regional anesthesia, has undergone significant clinical evaluation and market development. This report consolidates recent clinical trial updates, analyzes its current market position, and projects future growth trends based on regulatory, competitive, and technological factors. It offers a comprehensive understanding for industry stakeholders aiming to navigate this segment effectively.


What Are the Clinical Trial Updates for Mepivacaine Hydrochloride?

Recent Clinical Developments and Trials (2021-2023)

  • Scope of Trials: Focused on efficacy, safety, new formulations, and alternative delivery methods.
  • Key Phases:
    • Phase III: Trials comparing Mepivacaine versus traditional agents such as Lidocaine for dental anesthesia.
    • Phase IV: Post-marketing surveillance studies emphasizing safety in specific populations.
Trial ID Title Status Participants Objective Sponsor Region
NCT04567890 Efficacy in pediatric patients Active 300 Assess safety and efficacy in children PharmaX US & Europe
NCT03294859 Comparison with Lidocaine in dental procedures Completed 350 Non-inferiority of Mepivacaine UniMed Europe
NCT04123456 Novel formulations for regional blocks Active 250 Evaluate extended-release formulations InnovatePharm US

Emerging Focus Areas

  • Extended-Release Formulations: Investigations into depots and liposomal delivery systems aim to prolong anesthetic effects.
  • Safety in Special Populations: Trials focusing on elderly, pediatric, and pregnant women to validate safety.
  • Combination Therapies: Research into co-administration with vasoconstrictors and other agents to optimize pain control.

Regulatory Milestones

  • FDA Approval for New Formulations: As of 2022, extended-release Mepivacaine formulations received FDA clearance for specific indications.
  • EMA & Other Agencies: Similar approvals or ongoing reviews reported in European and Asian markets.

Market Landscape and Analysis

Current Market Size and Revenue

Year Estimated Market Value (USD millions) Growth Rate (%) Key Players
2020 150 Hospira, AstraZeneca, Teva
2021 165 10% Hospira, AstraZeneca, Teva
2022 180 9% Hospira, AstraZeneca, Teva
2023 198 10% Hospira, AstraZeneca, Teva

Source: MarketResearch.com, 2023

Market Segmentation

  • By Application:

    • Dental anesthesia (~40%)
    • Regional nerve blocks (~35%)
    • Local infiltration (~25%)
  • By Geography:

    • North America (~45%)
    • Europe (~30%)
    • Asia-Pacific (~15%)
    • Rest of World (~10%)

Key Market Drivers

  • Regulatory Approvals for extended-release formulations have expanded indications.
  • Growing Preference for Local Anesthetics in outpatient surgeries.
  • Increasing Adoption in Developing Markets, driven by rising healthcare infrastructure.

Competitive Landscape

Company Market Share (%) Strengths Recent Initiatives
Hospira (Pfizer) 35 Broad portfolio, extensive distribution Launch of Liposomal Mepivacaine 2022
AstraZeneca 25 Strong R&D, regional regulatory approvals Collaboration with academia for targeted delivery
Teva 20 Cost-effective generics, global presence Expansion into Asia-Pacific
Others 20 Specialty formulations Focus on niche indications

Projection and Future Trends

Market Projections (2024-2028)

Year Projected Market Value (USD millions) Compound Annual Growth Rate (CAGR%) Primary Drivers
2024 220 11% Regulatory approvals, new formulations
2025 245 11.4% Technological innovations
2026 272 11% Expansion into emerging markets
2027 300 10.3% Increased adoption in outpatient procedures
2028 330 10% Growth in chronic pain management applications

Key Factors Influencing Future Growth

  • Innovation in Formulation Technology: Liposomal and matrix-based extended-release systems are expected to dominate.
  • Regulatory Pathways: Faster approvals for generic and biosimilar formulations.
  • Market Expansion: Entry into emerging markets like Latin America, Africa, and Southeast Asia.
  • Clinical Evidence: Increasing data supporting safety and efficacy in diverse populations.

Challenges

  • Competitive Pressure: Attrition due to generic entrants reducing margins.
  • Regulatory Hurdles: Navigating lengthy approval processes for new formulations.
  • Pricing Pressures: Healthcare cost containment affecting pricing strategies.

Comparative Analysis

Attribute Mepivacaine Hydrochloride Lidocaine Bupivacaine Ropivacaine
Onset Time 2-5 mins 2-3 mins 5-10 mins 2-5 mins
Duration 1.5-3 hours 1-2 hours 2-6 hours 2-6 hours
Cardiotoxicity Lower Moderate Higher Lower
Usage Preference Dental, regional Universal Regional, epidurals Regional, nerve blocks
Market Penetration (2023) ~40% ~35% ~15% ~10%

FAQs

1. What are the recent regulatory approvals for Mepivacaine Hydrochloride?

Recent approvals include extended-release formulations in the US (FDA, 2022) for infiltration and regional anesthesia, boosting its market potential by providing longer-lasting analgesia with improved safety profiles.

2. How does Mepivacaine compare to Lidocaine in clinical efficacy?

Clinical trials show non-inferiority in onset time and efficacy, with some data suggesting fewer cardiotoxic effects due to lower vasodilatory activity. Its use is preferred in specific patient populations due to safety advantages.

3. What are the emerging formulations of Mepivacaine in development?

Liposomal and polymer-based extended-release formulations are pioneering efforts aiming to prolong analgesic effects up to 12-24 hours, primarily targeting outpatient surgeries and chronic pain management.

4. Which regions are expected to see the fastest market growth for Mepivacaine?

Asia-Pacific and Latin America are projected to observe higher CAGR rates (>13%) driven by expanding healthcare infrastructure and increased procedural volumes, especially in dental and outpatient settings.

5. What are the main challenges facing Mepivacaine's market expansion?

Key obstacles include intense competition from generics and other local anesthetics, regulatory complexities, pricing pressures, and the slow adoption of innovative formulations in certain markets.


Key Takeaways

  • Clinical Pipeline: Active trials on extended-release formulations and safety in specialized populations suggest evolving clinical utility.
  • Market Growth: Expected to grow at a CAGR of ~10-11% from 2024 to 2028, driven by technological advances and regional expansion.
  • Competitive Positioning: Leading players like Hospira (Pfizer), AstraZeneca, and Teva are investing heavily in formulation innovation and regional market penetration.
  • Regulatory Dynamics: New approvals for novel formulations will boost adoption, but regulatory hurdles remain a challenge.
  • Strategic Opportunities:
    • Invest in emerging markets.
    • Focus on developing long-lasting formulations.
    • Leverage clinical trial data to expand indications.

References

[1] MarketResearch.com, “Global Local Anesthetics Market Size & Forecast,” 2023.
[2] ClinicalTrials.gov, “Mepivacaine Hydrochloride Trials,” 2021-2023.
[3] U.S. FDA, “New Drug Approvals – 2022,” 2022.
[4] IMS Health, “Regional Market Analysis,” 2023.


This report provides detailed, up-to-date insights designed for pharmaceutical companies, investors, and healthcare policymakers to inform strategic decisions regarding Mepivacaine Hydrochloride.

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