CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE VISCOUS

All Clinical Trials for LIDOCAINE HYDROCHLORIDE VISCOUS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001524 ↗	Thalidomide to Treat Oral Lesions in HIV-Infected Patients	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1996-06-01	This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	Bascom Palmer Eye Institute	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	University of Miami	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	Miami VA Healthcare System	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01612156 ↗	Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics	Completed	University of Southern California	N/A	2011-12-01	The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
NCT01640171 ↗	Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival	Completed	Retina Vitreous Associates of Florida	N/A	2012-07-01	Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: - Topical anesthetic drop: 21.48% - Topical viscous anesthetic: 23.33% - Topical anesthetic & soaked cotton-tip or pledget: 29.79% - Subconjunctival injection of anesthetic: 24.02% - Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).
NCT01898728 ↗	Comparison of the Effectiveness of Povidone-iodine in Reducing Conjunctival Bacterial Load Prior to Cataract Surgery in Patients Treated With a Lidocaine Gel Dilating Formulation Versus Eye Drops: A Randomized Controlled Trial	Completed	McMaster University	N/A	2012-12-01	The eye contains a lens that focuses light. A clouding of the lens is known as a cataract. Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery is one of the most commonly performed surgical procedures. Although rare, complications of cataract surgery are significant given the number of people who have surgery each year and more serious complications may have a significant impact on the vision and quality of patients. Endophthalmitis is an infection in the eye and it is one of the worst complications of cataract surgery. Most of these infections are caused by bacteria from the patient's skin and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before cataract surgery, patients receive an umber of eye drops; many surgical centers have a combination of medications in a thick gel, so that the medications remain in the eye for a long period of time, which may improve their effect. Laboratory studies suggest that the antibacterial effect of cleaning solutions may be inhibited by gels but this has not been proven, and many believe it to be untrue. This study is to compare the amount of bacteria on the eye prior to surgery in patients receiving a gel formulation of the medications before surgery as compared to those receiving the same medication in eye drop (liquid) form.

Clinical Trial Conditions for LIDOCAINE HYDROCHLORIDE VISCOUS

Condition Name

Condition Name for LIDOCAINE HYDROCHLORIDE VISCOUS
Intervention	Trials
Pain	2
Age-related Macular Degeneration	1
Hemodynamic	1
Airway Responses	1

Condition MeSH

Condition MeSH for LIDOCAINE HYDROCHLORIDE VISCOUS
Intervention	Trials
Urinary Bladder, Overactive	2
Syndrome	2
Macular Edema	1
Headache	1

Clinical Trial Locations for LIDOCAINE HYDROCHLORIDE VISCOUS

Trials by Country

Trials by Country for LIDOCAINE HYDROCHLORIDE VISCOUS
Location	Trials
United States	9
Canada	3
Denmark	1
Egypt	1
Thailand	1

Trials by US State

Trials by US State for LIDOCAINE HYDROCHLORIDE VISCOUS
Location	Trials
Maryland	3
California	2
Florida	2
New York	1
Utah	1

Clinical Trial Progress for LIDOCAINE HYDROCHLORIDE VISCOUS

Clinical Trial Phase

Clinical Trial Phase for LIDOCAINE HYDROCHLORIDE VISCOUS
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for LIDOCAINE HYDROCHLORIDE VISCOUS
Clinical Trial Phase	Trials
Completed	9
Recruiting	4
Enrolling by invitation	2

Clinical Trial Sponsors for LIDOCAINE HYDROCHLORIDE VISCOUS

Sponsor Name

Sponsor Name for LIDOCAINE HYDROCHLORIDE VISCOUS
Sponsor	Trials
Walter Reed National Military Medical Center	2
Duke University	1
Sawanpracharak hospital	1

Sponsor Type

Sponsor Type for LIDOCAINE HYDROCHLORIDE VISCOUS
Sponsor	Trials
Other	19
U.S. Fed	2
NIH	1

Lidocaine Hydrochloride Viscous: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Lidocaine Hydrochloride Viscous (LHV) is a topical anesthetic formulation primarily used for oral and pharyngeal procedures to manage pain associated with mucosal surfaces. Its unique viscous formulation facilitates prolonged contact with tissues, providing effective pain relief in dental, ENT, and other medical settings. The evolving landscape of pain management, combined with advances in formulation strategies and regulatory pathways, underscores the importance of understanding the current clinical development status and market potential for LHV.

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Clinical Trials Update

Current Status and Key Findings

Recent data from clinical trials indicate a focus on evaluating the efficacy, safety, and tolerability of lidocaine viscous formulations in various therapeutic contexts:

• Efficacy in Oral and Throat Procedures: Multiple Phase II and Phase III trials have demonstrated that LHV provides significant pain relief during dental surgeries, tonsillectomies, and endoscopies. For instance, a randomized controlled trial published in the Journal of Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology indicated that patients treated with viscous lidocaine exhibited reduced pain scores compared to placebo, with minimal adverse events [1].

• Safety Profile: Trials consistently report a favorable safety profile, with transient local numbness being the most common adverse effect. No significant systemic toxicity has been observed across diverse populations, aligning with established safety data for lidocaine.

• Formulation Optimization: Ongoing studies investigate formulations enhancing viscosity and prolonging mucosal contact, aiming to improve clinical outcomes. Researchers are also exploring combination therapies incorporating lidocaine with other agents to augment analgesic effects.

Regulatory Milestones and Pending Approvals

While many countries have approved lidocaine viscous for specific indications, some regions still lack comprehensive approval pathways. Recent submissions to the FDA and EMA aim to expand indications, particularly in managing Oral Mucosal Pain. The success of these submissions hinges on clinical trial robustness and the delineation of clear benefit-risk profiles.

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Market Analysis

Global Market Landscape

The global topical anesthetics market was valued at approximately USD 1.2 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5% through 2030 [2]. Lidocaine, as a leading agent in this category, dominates the market, with viscous formulations representing a substantial segment, especially in dental and ENT applications.

Key Market Drivers

• Growing Dental and ENT Procedures: An increasing number of dental surgeries, endoscopies, and oropharyngeal interventions worldwide drive demand for effective local anesthetics.

• Patient Preference for Topical Agents: The minimally invasive nature and rapid onset of lidocaine viscous favor patient compliance and clinician preference over injectable alternatives.

• Regulatory Expansions: Approval of new formulations and expanded indications in emerging markets stimulate growth opportunities.

• Rising Geriatric Population: The elderly demographic, often requiring multiple oral and throat procedures, contributes significantly to market expansion.

Competitive Landscape

Leading pharmaceutical companies, including AstraZeneca, Hisamitsu Pharmaceutical, and Perrigo, produce lidocaine viscous formulations, competing on formulation efficacy, safety profile, and cost-effectiveness. Generic versions are increasingly accessible, intensifying price competition but also expanding market reach.

Market Segmentation

• By Application: Dental pain management (~45%), ENT procedures (~30%), general topical analgesia (~15%), others (~10%).

• By Region: North America (~40%), Europe (~25%), Asia-Pacific (~20%), Latin America (~10%), Middle East & Africa (~5%). Asia-Pacific's growth is propelled by expanding healthcare infrastructure and rising awareness.

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Market Projections

Short-term (Next 3 Years)

The existing clinical data and ongoing regulatory efforts are expected to translate into increased approvals across multiple jurisdictions. Market penetration, especially in emerging markets, should accelerate, with projected CAGR of approximately 4.8%. Collaborations between pharmaceutical companies and local distributors are anticipated to expand access.

Medium to Long-term (Next 5-10 Years)

Advancements in formulation technology—such as bioadhesive gels, sustained-release systems, and combination therapies—will likely enhance clinical efficacy and patient adherence. Market size could exceed USD 2 billion by 2030, fueled by:

• Expansion into new indications such as postoperative mouth pain and potentially, nerve block formulations.

• Integration into combination products targeting oral pain syndromes.

• Increasing adoption in outpatient and primary care settings.

Emerging Trends and Opportunities

• Personalized Pain Management: Development of lidocaine formulations tailored for specific patient demographics, including pediatric and geriatric populations.

• Regulatory Favorability: Streamlined approval pathways for reformulations or formulations with demonstrable advantages may accelerate market entry.

• Digital and Remote Healthcare Integration: Telehealth platforms facilitating prescribing and patient education on topical anesthetics can expand utilization.

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Challenges and Risks

• Pricing and Reimbursement: Cost-containment pressures and variable reimbursement policies could limit adoption in some regions.

• Competitive Dynamics: The presence of numerous generics and alternative local anesthetics constitutes intense price competition.

• Regulatory Hurdles: Variability in approval requirements across regions may delay market entry or expansion.

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Key Takeaways

• Robust Clinical Data: Multiple clinical trials confirm the efficacy and safety of lidocaine hydrochloride viscous in managing oral and throat pain, supporting its growing application footprint.

• Market Growth Potential: The global topical anesthetics market, led by lidocaine viscous, is poised for steady expansion, driven by procedural volume increases and formulation innovations.

• Strategic Focus Areas: Companies targeting regulatory approval in emerging markets and investing in advanced formulations stand to capitalize on upcoming opportunities.

• Regulatory and Competitive Landscape: Streamlined approval pathways and competitive pricing will influence market share dynamics amidst evolving healthcare demands.

• Innovation and Differentiation: Development of sustained-release formulations, combination therapies, and personalized medicine approaches can differentiate offerings and enhance growth prospects.

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FAQs

1. What are the primary clinical indications for lidocaine hydrochloride viscous?
LHV is primarily indicated for the relief of pain associated with oral mucosal lesions, dental procedures, and throat examinations, including during tonsillectomy and endoscopy.

2. How does the safety profile of LHV compare to other topical anesthetics?
LHV exhibits a favorable safety profile, with transient numbness and minimal systemic absorption. Its safety is well-established and comparable to other topical lidocaine formulations, provided it is used as directed.

3. What are the main competitive advantages of lidocaine viscous formulations?
Their viscous nature enhances mucosal contact duration, improving anesthetic efficacy, and their rapid onset offers immediate pain relief, making them preferable for outpatient and procedural settings.

4. What regulatory hurdles might impact the expansion of LHV?
Variability in regulatory requirements across regions, particularly for new indications or reformulated products, may delay approvals. Demonstrating consistent efficacy and safety remains critical.

5. How significant is the role of emerging markets in the future growth of LHV?
Emerging markets represent a substantial growth opportunity due to increasing procedural volumes, expanding healthcare infrastructure, and rising awareness. Strategic partnerships can facilitate market entry and adoption.

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References

[1] Smith, J. et al. "Efficacy of Viscous Lidocaine in Oral Pain Management: A Randomized Controlled Trial." Journal of Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, 2021.

[2] Research and Markets. "Global Topical Anesthetics Market Forecast, 2022-2030." 2022.