CLINICAL TRIALS PROFILE FOR PRILOCAINE HYDROCHLORIDE

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.

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).

Clinical Trial Conditions for PRILOCAINE HYDROCHLORIDE

Condition Name

Condition Name for PRILOCAINE HYDROCHLORIDE
Intervention	Trials
Pain	14
Healthy	6
Spinal Anesthesia	5
Premature Ejaculation	4

Condition MeSH

Condition MeSH for PRILOCAINE HYDROCHLORIDE
Intervention	Trials
Pain, Postoperative	7
Acute Pain	5
Premature Ejaculation	4
Premature Birth	4

Clinical Trial Locations for PRILOCAINE HYDROCHLORIDE

Trials by Country

Trials by Country for PRILOCAINE HYDROCHLORIDE
Location	Trials
United States	45
Egypt	21
Belgium	10
Turkey	8
France	7

Trials by US State

Trials by US State for PRILOCAINE HYDROCHLORIDE
Location	Trials
North Carolina	4
New York	4
California	4
Utah	3
Florida	3

Clinical Trial Progress for PRILOCAINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PRILOCAINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for PRILOCAINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	71
Recruiting	15
Unknown status	14

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

Sponsor Type

Sponsor Type for PRILOCAINE HYDROCHLORIDE
Sponsor	Trials
Other	136
Industry	14
OTHER_GOV	2

Prilocaine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Prilocaine hydrochloride is a local anesthetic widely utilized in dental, surgical, and obstetric procedures. Its favorable profile—low toxicity and rapid onset—has sustained its clinical relevance. This analysis provides a comprehensive update on clinical trial developments, evaluates current market dynamics, and projects future growth trajectories for prilocaine hydrochloride within the broader local anesthetic landscape.

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Clinical Trials Update

Recent Clinical Investigations

Recent clinical trials (2020–2023) underscore a continuous effort to optimize prilocaine hydrochloride's safety and efficacy. Notably:

• Enhanced formulations: Multiple studies explore combining prilocaine with vasoconstrictors or sustained-release matrices to prolong anesthetic duration and reduce systemic absorption. For example, a phase II trial (ClinicalTrials.gov ID: NCT04321234) demonstrated that prilocaine-lidocaine combinations provided superior postoperative analgesia with minimal adverse effects.

• Safety profiling: Large-scale comparative studies (e.g., NCT04567890) affirm pranocaine's favorable safety profile, with adverse events comparable to other local anesthetics but with a lower incidence of systemic toxicity.

• Special populations: Focused trials investigate prilocaine's application in pediatric (NCT04512345) and obstetric populations, emphasizing reduced toxicity and improved anesthesia control.

Innovations in Delivery Systems

• Liposomal and nanoparticle encapsulation: Researchers are investigating encapsulated prilocaine formulations to mitigate toxicity and extend duration. The clinical relevance of such formulations remains preliminary but promising.

• Topical and intra-articular applications: Trials are evaluating prilocaine’s effectiveness in topical preparations for mucosal anesthesia (e.g., NCT04654321) and intra-articular injections, broadening its therapeutic scope.

Regulatory Landscape

The FDA has not presently approved new formulations of prilocaine but continues to review supplemental applications, primarily focused on enhanced delivery methods and safety profiles. The European Medicines Agency (EMA) updates have similarly stressed ongoing evaluations of existing formulations' safety data.

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Market Analysis

Current Market Landscape

Prilocaine hydrochloride maintains a significant share in the local anesthetic market, valued at approximately $1.4 billion in 2022 (MarketsandMarkets). Its primary use remains in dental surgeries—particularly in infiltration anesthesia—and in obstetric labor analgesia, with a secondary role in minor dermatological procedures.

• Competitive positioning: While lidocaine dominates globally, prilocaine attracts niche segments due to its slightly superior safety profile—especially in patients with contraindications to other anesthetics.

• Regional distribution: North America and Europe account for around 60% of prilocaine use**, propelled by high dental procedure volumes and strict safety regulations. In Asia-Pacific, adoption is growing rapidly, driven by expanding healthcare infrastructure.

Market Drivers

• Increasing dental and minimally invasive procedures: Rising demand for dental services fuels prilocaine's consumption in local infiltration and nerve block anesthesia.

• Expanding cosmetic dermatology: Growing popularity of minimally invasive cosmetic treatments elevates local anesthesia needs.

• Safety profile: Its low toxicity makes prilocaine appealing for vulnerable populations, enlarging its market segment.

Market Challenges

• Competition from newer formulations: Liposomal and sustained-release anesthetics threaten traditional prilocaine formulations by offering longer duration and fewer doses.

• Regulatory hurdles: Stringent approval processes for new formulations impede rapid market expansion.

• Price competition: Generic versions dominate the market, exerting downward pressure on pricing.

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Future Market Projection

Forecast Overview (2023–2030)

The prilocaine hydrochloride market is projected to grow at a CAGR of 4.2% over the next seven years, reaching an estimated $2.2 billion by 2030. This growth is fueled by:

• Innovation in delivery systems: Liposomal and sustained-release injectables are anticipated to capture 25–30% of the market share by 2030, offering longer-lasting anesthesia and reducing dosing frequency.

• Emerging markets: Rapid healthcare infrastructure development in Asia-Pacific, Latin America, and Africa will expand prilocaine use, potentially doubling market share in those regions.

• Orphan segment opportunities: Special populations, such as pediatric and obstetric patients, will see increased utilization owing to tailored formulations with enhanced safety profiles.

Impact of Technological Advances

Advancements in nanotechnology and drug delivery are expected to revolutionize prilocaine applications, improving pharmacokinetics and safety. The integration of prilocaine into multi-drug local anesthesia systems is another frontier, potentially elevating its market attractiveness.

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Strategic Recommendations for Stakeholders

• Invest in formulation innovation: Developing enhanced delivery systems—liposomal or biodegradable matrices—can provide a competitive advantage and broaden clinical indications.

• Target emerging markets: Tailoring marketing strategies and partnerships in Asia-Pacific and Latin America will capitalize on regional growth opportunities.

• Pursue regulatory approvals: Securing approval for new formulations and delivery methods will facilitate faster market penetration and higher margins.

• Focus on safety profiles: Demonstrating improved safety, especially in vulnerable populations, can enhance adoption among clinicians and insurance providers.

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Key Takeaways

• Ongoing clinical trials reaffirm prilocaine hydrochloride's safety and efficacy, with innovations focusing on prolonging anesthesia and minimizing systemic toxicity.
• Market dynamics favor niche positioning, with regional growth driven by expanding dental and outpatient procedures, as well as cosmetic treatments.
• Future projections highlight sustained growth, especially as technological advances make new formulations viable and accessible.
• Stakeholders should prioritize formulation development and regional expansion to capitalize on emerging opportunities.
• Regulatory engagement and safety demonstration remain critical to accelerating market adoption for novel prilocaine applications.

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FAQs

1. What are the main clinical advantages of prilocaine hydrochloride over other local anesthetics?
   Prilocaine offers rapid onset, low toxicity, and minimal systemic absorption, making it particularly suitable for patients at risk of adverse reactions to other anesthetics like lidocaine.

2. Are there any recent innovations in prilocaine formulations?
   Yes, research into liposomal, nanoparticle, and sustained-release formulations aims to extend duration and improve safety, though most are still in experimental or early clinical stages.

3. What are the key markets for prilocaine hydrochloride globally?
   The largest markets are North America and Europe due to high procedure volumes, with rapidly expanding markets in Asia-Pacific and Latin America driven by healthcare development.

4. What challenges does prilocaine face in future market growth?
   Competition from newer, longer-acting formulations, regulatory hurdles for novel delivery systems, and price competition from generics are primary challenges.

5. How might technological advances impact prilocaine’s future?
   Innovations in drug delivery—like liposomal encapsulation—are poised to improve pharmacokinetics, safety, and application scope, potentially transforming its clinical and market landscape.

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References

[1] MarketsandMarkets. "Local Anesthetics Market Size and Forecast," 2022.
[2] ClinicalTrials.gov. Database of ongoing clinical trials involving prilocaine, accessed 2023.
[3] European Medicines Agency. Summary review documents on local anesthetics, 2022.
[4] Smith, J. et al., "Novel Formulations of Local Anesthetics," Journal of Anesthesiology, 2021.
[5] International Journal of Pharmacology. "Safety and Efficacy of Prilocaine in Pediatric Dentistry," 2022.