Last Updated: May 26, 2026

CLINICAL TRIALS PROFILE FOR LIDOCAINE AND PRILOCAINE


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All Clinical Trials for Lidocaine And Prilocaine

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.
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.
NCT00556478 ↗ Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Completed Plethora Solutions Ltd 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.
NCT00808054 ↗ Evaluation of Analgesia With EMLA and Glucose Oral Solution Completed Federal University of Minas Gerais Phase 4 2008-11-01 In this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lidocaine And Prilocaine

Condition Name

Condition Name for Lidocaine And Prilocaine
Intervention Trials
Pain 13
Premature Ejaculation 4
Contraception 4
Anesthesia, Local 3
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Condition MeSH

Condition MeSH for Lidocaine And Prilocaine
Intervention Trials
Premature Ejaculation 4
Premature Birth 4
Hernia, Inguinal 3
Pain, Postoperative 3
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Clinical Trial Locations for Lidocaine And Prilocaine

Trials by Country

Trials by Country for Lidocaine And Prilocaine
Location Trials
United States 34
Egypt 10
France 6
Belgium 3
Italy 3
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Trials by US State

Trials by US State for Lidocaine And Prilocaine
Location Trials
North Carolina 4
California 3
Utah 3
New York 2
Illinois 2
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Clinical Trial Progress for Lidocaine And Prilocaine

Clinical Trial Phase

Clinical Trial Phase for Lidocaine And Prilocaine
Clinical Trial Phase Trials
PHASE4 2
PHASE3 1
PHASE2 2
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Clinical Trial Status

Clinical Trial Status for Lidocaine And Prilocaine
Clinical Trial Phase Trials
Completed 44
Unknown status 11
Recruiting 9
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Clinical Trial Sponsors for Lidocaine And Prilocaine

Sponsor Name

Sponsor Name for Lidocaine And Prilocaine
Sponsor Trials
Cairo University 6
Plethora Solutions Ltd 5
Assiut University 4
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Sponsor Type

Sponsor Type for Lidocaine And Prilocaine
Sponsor Trials
Other 87
Industry 12
NIH 2
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Lidocaine and Prilocaine: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the drug product landscape for lidocaine and prilocaine?

Lidocaine and prilocaine are local anesthetics used in topical fixed-dose combinations, most prominently as eutectic mixtures in creams and patches (commonly described as “lidocaine 2.5% and prilocaine 2.5%” in consumer and professional markets). The combination is used to reduce pain from minor superficial procedures and for application-site anesthesia prior to procedures such as needle insertion.

Core commercial positioning

  • Route/product format: topical application (cream/gel and adhesive patch formats)
  • Mechanism class: sodium channel blockers used for local anesthesia
  • Typical usage setting: dermatology, procedural pain management, minor medical interventions

Major known marketed combination

  • “EMLA” (commonly referenced as the archetypal lidocaine/prilocaine combination) is widely used internationally as a topical anesthetic for application-site pain reduction. Market data sources frequently categorize this combination as topical anesthetic/anesthetics rather than standalone “chemical” line items due to brand and formulation effects.

How do clinical development and trial activity currently map to this class?

Public clinical activity for lidocaine/prilocaine is typically dominated by:

  1. Formulation and bioavailability studies (new vehicles, delivery systems, penetration enhancers, patch design)
  2. Comparative local efficacy/safety trials against other topical anesthetics
  3. Indication expansion trials that remain procedural and pain-reduction oriented rather than disease-modifying

A complete “all-trials” adjudication across registries is not available in the provided dataset. No specific, registry-confirmed current-phase trial list (by sponsor, NCT number, phase, endpoints, and status) can be produced without risking incorrect claims.

What do the latest clinical-trial patterns imply for competitive R&D?

Clinical trial activity patterns for topical anesthetic combinations generally concentrate on time-to-onset, duration, depth-of-anesthesia surrogates, and tolerability (local irritation, erythema, hypersensitivity). For investment-grade evaluation of a lidocaine/prilocaine program, the discriminators are:

  • Onset and adequacy under real-world prep time
  • Consistency across skin sites (thinner vs thicker skin; pediatric vs adult)
  • Vehicle performance (cream vs gel vs patch changes penetration and user acceptability)
  • Safety in repeated/extended application (local irritation profiles and rare hypersensitivity)

How big is the lidocaine and prilocaine market today?

Market definition constraints

“Lidocaine and prilocaine” market sizing varies by:

  • whether the analyst includes only the fixed-dose eutectic combination branded as “EMLA-like,”
  • whether it includes all topical lidocaine-prilocaine formats (cream, patch, gel),
  • whether it is grouped under broader categories such as topical anesthetics or local anesthetics.

A reliable market number requires a specific taxonomy and a cited market research dataset. No cited market size, CAGR, or regional shares are provided in the source material available here.

What are the demand drivers and commercial headwinds?

Demand drivers

  • Procedural volume in dermatology and outpatient settings using topical anesthesia to reduce pain and improve patient compliance
  • Need for needle-related pain control in routine minor procedures
  • Preference for topical methods that reduce sedation requirements compared with injectable anesthesia in select settings

Commercial headwinds

  • Switching to alternatives (other topical anesthetic actives and combinations) based on perceived onset time, tolerability, and availability
  • Generic and formulation competition that compresses price per treatment
  • Regulatory and labeling constraints on indication scope and safe-use time windows

How should the market be projected for lidocaine and prilocaine?

Projection mechanics (what typically governs the curve)

For topical local anesthetic combinations, projections generally track:

  • procedure volume and setting migration (office-based care)
  • penetration of prescription and OTC pathways (varies by region and regulatory status)
  • treatment frequency per patient encounter
  • channel mix (hospital procurement vs retail)

What can be projected without numbers

A structured projection for lidocaine/prilocaine must state:

  • base-year market size
  • CAGR by geography
  • scenario assumptions (brand share vs generic share; patch adoption vs cream)

Those numeric inputs and citations are not present in the provided material. Producing numeric projections without a cited baseline would add unverifiable claims.

Actionable market and R&D implications for investors

Even without numerical market sizing, actionable conclusions can be drawn from product-development economics in topical local anesthesia:

Where differentiation has value

  • Faster onset that enables shorter application windows in busy clinics
  • Improved skin-site performance (e.g., consistent effect in joints/irritation-prone areas)
  • Better tolerability (reduced erythema/irritation rates at label-compliant dosing)
  • Device-adjacent innovation (patch adhesion, uniform dosing, reduced leakage)

Where duplication risk is high

  • New entrants that replicate existing vehicles without measurable performance improvements face compressed pricing and difficult reimbursement positioning.
  • Trials that do not use clinically meaningful endpoints for procedural pain adequacy create weaker payer and clinician acceptance.

Key Takeaways

  • Lidocaine and prilocaine are established topical local anesthetic combinations used for procedural pain reduction; competitive advantage typically comes from formulation and delivery improvements rather than new mechanism.
  • Clinical development in this class is typically dominated by formulation/bioavailability and comparative efficacy/safety trials.
  • Reliable market sizing and numeric projections require a cited market taxonomy and dataset; those inputs are not included here, so only structurally grounded strategy insights can be provided.
  • For R&D and investment decisions, the highest-leverage differentiation metrics are onset time, procedural adequacy, skin-site consistency, and tolerability under label-compliant use.

FAQs

  1. What are lidocaine/prilocaine combinations used for clinically?
    They are used to reduce pain at application sites prior to minor superficial procedures, most commonly in dermatology and outpatient settings.

  2. What differentiates one lidocaine/prilocaine product from another?
    Vehicle and delivery design (cream/gel vs patch), application time, penetration performance, and tolerability at comparable dosing.

  3. Are there disease-modifying indications in development for lidocaine/prilocaine?
    Publicly, the development pattern is typically procedural analgesia rather than disease modification.

  4. How do investors evaluate new topical anesthetic candidates in this space?
    They focus on clinically meaningful endpoints (pain reduction adequacy), time-to-onset, and safety/irritation profiles, plus device usability.

  5. What limits market growth for lidocaine/prilocaine combinations?
    Generic and formulation competition, substitution by alternative topical anesthetics, and constrained labeling on safe-use timing.


References

[1] ClinicalTrials.gov. Lidocaine and prilocaine search results. https://clinicaltrials.gov/ (accessed 2026-04-28)
[2] European Medicines Agency (EMA). Public product information and assessment documents related to topical lidocaine/prilocaine combinations. https://www.ema.europa.eu/ (accessed 2026-04-28)

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