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Last Updated: January 17, 2025

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 13
Healthy 6
Contraception 4
Premature Ejaculation 4
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Condition MeSH

Condition MeSH for Prilocaine Hydrochloride
Intervention Trials
Pain, Postoperative 6
Acute Pain 4
Premature Ejaculation 4
Premature Birth 3
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Clinical Trial Locations for Prilocaine Hydrochloride

Trials by Country

Trials by Country for Prilocaine Hydrochloride
Location Trials
United States 44
Egypt 13
Belgium 10
Turkey 8
France 6
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Prilocaine Hydrochloride
Clinical Trial Phase Trials
Phase 4 38
Phase 3 14
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Prilocaine Hydrochloride
Clinical Trial Phase Trials
Completed 61
Unknown status 14
Not yet recruiting 13
[disabled in preview] 19
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Clinical Trial Sponsors for Prilocaine Hydrochloride

Sponsor Name

Sponsor Name for Prilocaine Hydrochloride
Sponsor Trials
Cairo University 7
Plethora Solutions Ltd 5
Centre Hospitalier Universitaire Saint Pierre 5
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Sponsor Type

Sponsor Type for Prilocaine Hydrochloride
Sponsor Trials
Other 120
Industry 14
NIH 2
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Prilocaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Prilocaine hydrochloride is a local anesthetic of the amide type, widely used in various medical procedures, including dentistry, cosmetic surgeries, and minor invasive treatments. This article will delve into the current state of clinical trials, market analysis, and future projections for prilocaine hydrochloride.

Mechanism of Action and Clinical Use

Prilocaine hydrochloride acts by inhibiting sodium channels on the neuronal cell membrane, thereby reducing the propagation of nerve impulses and providing local anesthesia. It is commonly used in dentistry through nerve block or infiltration techniques and is also part of topical anesthetic creams, such as those combined with lidocaine[1][4].

Clinical Trials

While specific recent clinical trials on prilocaine hydrochloride alone are not extensively detailed in the available sources, it is often studied within the broader context of local anesthetics. For instance, clinical trials focusing on the efficacy and safety of prilocaine in combination with other anesthetics, such as lidocaine, are more common. These trials typically assess the anesthetic's effectiveness, duration of action, and side effect profile.

Safety and Efficacy

Clinical trials have shown that prilocaine hydrochloride is generally safe and effective when used appropriately. However, it is crucial to monitor patients for potential adverse reactions, such as methemoglobinemia, especially when combined with other medications that can increase this risk[4].

Market Analysis

The market for prilocaine hydrochloride, particularly in the form of lidocaine and prilocaine cream, is experiencing significant growth.

Market Drivers

Several factors are driving the growth of the lidocaine and prilocaine cream market:

  • Increasing Demand for Topical Anesthetics: The rising need for non-invasive pain relief options in procedures like laser treatments, tattoos, and minor surgeries is a key driver[2].
  • Growing Prevalence of Skin Conditions: The increase in dermatological conditions and treatments where local pain management is essential further fuels market demand[2].
  • Advancements in Product Formulations: Innovations in pharmaceutical formulations offering enhanced efficacy and longer-lasting relief are driving adoption and expanding the market's potential[2].

Market Size and Growth

The lidocaine and prilocaine cream market is anticipated to witness a compound annual growth rate (CAGR) of 7.99% from 2024 to 2031, transitioning from a valuation of USD 6.6 billion in 2024 to USD 11.3 billion by 2031[2].

Regional Analysis

The market is distributed across various regions:

  • Asia-Pacific: This region is rapidly growing due to countries like China, Japan, India, and South Korea, driven by a large population, rising disposable income, and increasing urbanization[2].
  • Europe: Europe is characterized by a mature market with well-established infrastructure and consumer preferences, including countries such as the UK, Germany, France, and Italy[2].
  • Latin America and Middle East & Africa: These regions present opportunities and challenges, with countries like Brazil, Mexico, and Argentina in Latin America, and UAE, Saudi Arabia, South Africa, and Nigeria in the Middle East and Africa showing promising growth potential[2].

Market Projections

Future Growth Prospects

The future of the lidocaine and prilocaine cream market looks promising due to several factors:

  • Increasing Urbanization: The rising urban population is propelling the demand for these creams, especially in urban centers[2].
  • Sustainable Solutions: Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives, boosting the demand for eco-friendly products[2].
  • Mergers and Acquisitions: The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness[2].

Key Players

The market is dominated by several key players, including Tongfang Pharma, Aspen Pharma, Octavius Pharma, Padagis, and Akorn. These companies are focusing on expanding their product lines, innovating formulations, and accessing new technologies through acquisitions[2].

Adverse Effects and Precautions

While prilocaine hydrochloride is generally safe, it is important to be aware of potential adverse effects:

  • Methemoglobinemia: A significant risk, especially when combined with other medications that can increase this risk[4].
  • Cardiovascular Effects: Bradycardia, hypotension, and cardiovascular collapse are possible adverse reactions[4].
  • Allergic-Type Reactions: Patients should be monitored for any signs of allergic reactions[4].

Key Takeaways

  • Mechanism of Action: Prilocaine hydrochloride inhibits sodium channels on the neuronal cell membrane.
  • Clinical Use: Commonly used in dentistry and as part of topical anesthetic creams.
  • Market Growth: The lidocaine and prilocaine cream market is expected to grow at a CAGR of 7.99% from 2024 to 2031.
  • Regional Analysis: Asia-Pacific, Europe, Latin America, and the Middle East & Africa are key regions driving market growth.
  • Adverse Effects: Methemoglobinemia, cardiovascular effects, and allergic-type reactions are potential risks.

FAQs

What is the primary mechanism of action of prilocaine hydrochloride?

Prilocaine hydrochloride acts by inhibiting sodium channels on the neuronal cell membrane, thereby reducing the propagation of nerve impulses and providing local anesthesia[1].

What are the common uses of prilocaine hydrochloride?

It is commonly used in dentistry through nerve block or infiltration techniques and is also part of topical anesthetic creams, such as those combined with lidocaine[4].

What are the key drivers of the lidocaine and prilocaine cream market?

The market is driven by increasing demand for topical anesthetics, growing prevalence of skin conditions, advancements in product formulations, and increasing urbanization[2].

What is the projected market size of the lidocaine and prilocaine cream market by 2031?

The market is anticipated to reach a valuation of USD 11.3 billion by 2031, growing at a CAGR of 7.99% from 2024 to 2031[2].

What are the potential adverse effects of prilocaine hydrochloride?

Potential adverse effects include methemoglobinemia, cardiovascular effects such as bradycardia and hypotension, and allergic-type reactions[4].

Sources

  1. DrugBank Online - Prilocaine: Uses, Interactions, Mechanism of Action.
  2. OpenPR - Lidocaine and Prilocaine Cream Market Size, Share and Forecast.
  3. GlobeNewswire - Local Anesthesia Drugs Market is estimated to be US$ 8.5 billion by 2032.
  4. eMPR - Prilocaine HCl Prescription & Dosage Information.
  5. AstraZeneca - Environmental Risk Assessment Data Prilocaine hydrochloride.

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