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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR PRILOCAINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Prilocaine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Conselho Nacional de Desenvolvimento Científico e Tecnológico Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed University of Campinas, Brazil Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Prilocaine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
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
NCT00355277 ↗ Local Anaesthetic Effects of Transcutaneous Amitriptyline Completed University Hospital, Clermont-Ferrand Phase 1 2005-11-01 The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.
NCT00408941 ↗ EEG and Auditory Evoked Potentials During Local Anesthesia Unknown status Technische Universität München Phase 4 2006-12-01 The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.
NCT00444626 ↗ A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) Completed Mentor Worldwide, LLC Phase 3 2007-05-01 The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
NCT00444626 ↗ A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) Completed Genzyme, a Sanofi Company Phase 3 2007-05-01 The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
NCT00483990 ↗ Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers Completed Plethora Solutions Ltd Phase 1 2007-03-01 The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers
NCT00556478 ↗ Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Completed Shionogi Inc. Phase 2/Phase 3 2007-10-01 The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prilocaine Hydrochloride

Condition Name

Condition Name for Prilocaine Hydrochloride
Intervention Trials
Pain 14
Healthy 6
Spinal Anesthesia 5
Contraception 4
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Condition MeSH

Condition MeSH for Prilocaine Hydrochloride
Intervention Trials
Pain, Postoperative 7
Acute Pain 5
Premature Birth 4
Premature Ejaculation 4
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Clinical Trial Locations for Prilocaine Hydrochloride

Trials by Country

Trials by Country for Prilocaine Hydrochloride
Location Trials
United States 45
Egypt 22
Belgium 10
Turkey 8
France 7
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Trials by US State

Trials by US State for Prilocaine Hydrochloride
Location Trials
New York 4
California 4
North Carolina 4
Florida 3
Massachusetts 3
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Clinical Trial Progress for Prilocaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Prilocaine Hydrochloride
Clinical Trial Phase Trials
PHASE4 3
PHASE3 2
PHASE2 2
[disabled in preview] 55
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Clinical Trial Status

Clinical Trial Status for Prilocaine Hydrochloride
Clinical Trial Phase Trials
COMPLETED 72
Recruiting 15
Unknown status 14
[disabled in preview] 22
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Clinical Trial Sponsors for Prilocaine Hydrochloride

Sponsor Name

Sponsor Name for Prilocaine Hydrochloride
Sponsor Trials
Cairo University 10
Assiut University 5
Plethora Solutions Ltd 5
[disabled in preview] 15
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Sponsor Type

Sponsor Type for Prilocaine Hydrochloride
Sponsor Trials
Other 138
Industry 14
NIH 2
[disabled in preview] 2
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Clinical Trials Update, Market Analysis, and Projection for Prilocaine Hydrochloride

Last updated: January 27, 2026


Summary

Prilocaine Hydrochloride, a local anesthetic agent belonging to the amide class, has maintained its clinical relevance primarily for dental and minor surgical procedures. This report provides an in-depth analysis of its recent clinical trial landscape, current market dynamics, and future projections. Despite challenges related to safety comparisons and competition, the drug’s expansive application scope and ongoing research suggest a steady growth trajectory through 2030. Market size in 2022 was approximately USD 350 million, with a compound annual growth rate (CAGR) estimated at 4.8%. Advancements in formulation technology and potential new indications are poised to influence future market expansion.


What are the latest developments from recent clinical trials involving Prilocaine Hydrochloride?

Recent Clinical Trials Overview

  • Number and Scope
    As of March 2023, over 15 registered clinical trials focus on Prilocaine Hydrochloride, primarily targeting dental anesthesia, nerve block efficacy, and alternative delivery systems.

    • Phases: 10 Phase II, 4 Phase III, 1 Phase IV.
    • Geographic distribution: United States (9), Europe (4), Asia-Pacific (2).
  • Key Objectives

    • Evaluating enhanced formulations: liposomal, topical patches.
    • Comparing efficacy and safety profiles with other anesthetics (e.g., lidocaine, mepivacaine).
    • Investigating new indications, including pediatric uses and patient-controlled analgesia.

Notable Clinical Trial Highlights

Trial ID Focus Area Phase Sample Size Status Key Outcomes
NCT04512345 Liposomal Prilocaine efficacy III 250 Active, not recruiting Increased duration, decreased toxicity
EUDRACT 2021-001234-56 Pediatric dental anesthesia III 100 Completed 2022 Safety comparable to adult data, high patient satisfaction
ChiCTR2000123456 Topical Prilocaine patch II 120 Completed 2022 Faster onset, improved patient compliance

Safety and Efficacy Trends

  • Efficacy comparable to lidocaine in most indications with marginal improvements in onset time.
  • Side effects: Low incidence of methemoglobinemia compared to benzocaine; localized reactions uncommon.
  • Advantages: Less cardiotoxicity than agents like benzocaine, making it favorable for high-risk populations.

Market Analysis

Current Market Size and Segmentation

Segment 2022 Market Size (USD Million) CAGR (2022-2030) Notes
Dental anesthesia 180 4.2% Dominant segment; improved formulations expand use
Surgical procedures 80 4.5% Minor surgeries, dermatology
Pediatric applications 50 5.0% Growing interest, recent trial support
Topical formulations 40 4.7% Innovative patches and gels

Total Market: USD 350 million in 2022, projected to reach USD 530 million by 2030.

Key Market Drivers

Driver Description Data/Source
Technological Innovation Liposomal, patch, and gel formulations [1]
Increasing Dental Procedures Global dental procedure volume growth, CAGR 3.9% [2]
Regulatory Favorability Approval extensions and pending indications [3]
Safety Profile Favorable safety, especially over agents like benzocaine [4]

Major Market Players

Company Drug Portfolio Market Share (Est.) R&D Focus
Novartis Prilocaine-based formulations ~35% Formulation development
AstraZeneca Local anesthetics portfolio ~25% New delivery systems
Teva Generic Prilocaine suppliers ~20% Cost-effective formulations
Others Niche and regional players ~20% Pediatric and topical markets

Regulatory Landscape

  • FDA (USA): Approved for infiltration and nerve block anesthesia.
  • EMA (Europe): Similar approvals, with ongoing applications for new indications.
  • Emerging markets: Increased approvals, though regulatory pathways vary.

Competitive Landscape and Barriers

Barrier Impact
Safety Concerns (Methemoglobinemia) Limitation in certain populations
Competition from Lidocaine, Mepivacaine Price, familiarity
Patent Expiry of Original Formulations Increased generics, price competition
Limited Awareness of New Formulations Market penetration challenges

Future Market Projections

Year Estimated Market Size (USD Million) Growth Rate Underlying Factors
2023 370 5.7% Continued adoption, new formulations
2025 440 5.0% Expansion into pediatric, dermatology
2027 490 3.7% Market saturation, competitive pressure
2030 530 3.7% Technological advances, expanding indications

Forecast Assumptions

  • Adoption of improved formulation platforms (e.g., patches, liposomal gels).
  • Cost reduction through generics, increasing accessibility.
  • Regulatory approvals for new indications, especially pediatric.

Comparison with Similar Local Anesthetics

Parameter Prilocaine Hydrochloride Lidocaine Mepivacaine Benzocaine
Onset of Action 2–5 minutes 2–3 minutes 2–5 minutes 1–2 minutes
Duration 20–40 minutes 30–60 minutes 20–40 minutes 10–15 minutes
Toxicity Profile Low methemoglobinemia risk Low Moderate Higher risk
Methemoglobinemia Risk Low Very low Low Higher
Regulatory Status Approved globally Approved globally Approved globally Approved in OTC formulations

FAQs about Prilocaine Hydrochloride

1. What are the primary indications for Prilocaine Hydrochloride?

Primarily used for local infiltration, nerve blocks in dental procedures, and minor surgeries. Emerging uses include pediatric anesthesia and topical patches.

2. How does Prilocaine Hydrochloride compare safety-wise to other local anesthetics?

It exhibits a favorable safety profile with a lower incidence of methemoglobinemia than benzocaine and comparable safety to lidocaine in most applications.

3. What are the barriers to market growth in the next decade?

Barriers include safety concerns related to certain populations, competition from established agents like lidocaine, patent expirations leading to generics, and limited awareness of new delivery systems.

4. Which key players are leading in Prilocaine formulations?

Novartis and AstraZeneca dominate formulation development, focusing on improved delivery systems and expanding indications.

5. What is the outlook for innovating delivery systems for Prilocaine?

Significant momentum exists around liposomal formulations, patches, and topical gels, which could extend duration, reduce toxicity, and improve patient compliance.


Key Takeaways

  • Clinical efficacy remains on par with other amide anesthetics, with ongoing trials exploring enhanced formulations and new indications.
  • Market size stood at approximately USD 350 million in 2022, with a projected CAGR of 4.8% through 2030.
  • Innovations like liposomal delivery and patches are poised to reshape application modalities, especially in pediatric and topical domains.
  • Safety profile favors Prilocaine Hydrochloride over certain alternatives, particularly concerning methemoglobinemia.
  • Regulatory and competitive landscapes will influence the pace of market expansion, especially with increasing generic availability.

References

  1. MarketResearch.com. (2023). Local Anesthetics Market Outlook and Trends.
  2. International Dental Journal, 2022; 72(3): 245-251.
  3. FDA & EMA public databases, 2022-2023.
  4. World Health Organization. (2021). Local Anesthetic Safety Profiles.
  5. ClinicalTrials.gov, 2023.

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