CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

505(b)(2) Clinical Trials for Lidocaine Hydrochloride 0.4% In Dextrose 5%

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	NCT01348243 ↗	Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2011-10-01	Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis. The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at least as effective as daily oral therapy and appears more effective than intermittent intravenous treatment. Intramuscular clodronic acid in particular has also been associated with improvements in back pain. The drug is well tolerated, with no deleterious effects on bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal adverse effects that may be seen in patients receiving oral bisphosphonates therapy. In order to simplify the therapeutic dosing regimen, reducing the number of administrations per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the same concentration as in the 100 mg clodronic acid formulation. The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200 mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy post-menopausal volunteers. Two formulations were similar in terms of amount and rate of clodronic acid urinary excretion and in terms of safety profile.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02749123 ↗	Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis	Unknown status	J.A.R. Laboratories	N/A	2016-04-01	A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

All Clinical Trials for Lidocaine Hydrochloride 0.4% In Dextrose 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001303 ↗	Effects of Endotoxin in Normal Human Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	1992-04-06	Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts to humans, even though it is not an infection, it triggers a set of responses that are typical of what one would see with a true bacterial infection. This allows us to study the earliest changes in molecules and cells that are involved in some bacterial infections. This type of model is safe and has been used in humans for many years to understand the body s responses during infections. Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen for asymptomatic coronary artery disease. Participants will undergo one or more of the following procedures: Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal Biopsies: These techniques for examining lung function are used routinely in patient care and clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large airways of the lung. Cells and secretions from the airways are rinsed with salt water (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the ball of a ballpoint pen) lining the airways are removed for examination under the microscope. Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14 days to analyze the body s immune response to the bacteria in the blood. Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted through a bronchoscope into a lobe of one lung, and then salt water containing a small dose of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see above) are then done to study the response of the lung to the endotoxin. In addition, air is withdrawn through the bronchoscope to study air components from the lung that was instilled with salt water or endotoxin. Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per million, is given through a cushioned mask placed over the mouth and nose. (Some participants will be given the nitric oxide mixture and others will breathe only room air through the mask to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and biopsy. Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples. First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the artery, the catheter is slipped over the needle into the vessel, and the needle is removed.
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.
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00001784 ↗	Mexiletine for the Treatment of Focal Dystonia	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1998-07-01	Dystonia refers to a condition characterized by involuntary muscle contractions that may cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but some researchers believe it is a result of overactivity in the areas of the brain responsible for movement (basal ganglia). Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection. Recent studies have shown that lidocaine is also effective for the treatment dystonia. Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by mouth. Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia. Patients participating in the study will be divided into two groups; Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week then begin taking a placebo "inactive sugar pill" for an additional six weeks. Group 2 will take a placebo "inactive sugar pill" for six weeks then stop. They will remain drug free for one week then begin taking a Mexiletine for an additional six weeks. Throughout the study researchers will test the effectiveness of the treatment by evaluating patients using clinical rating scales and neurophysiological studies. In addition, researchers will test patient's reflexes in an attempt to find out where mexiletine works in the nervous system.

Clinical Trial Conditions for Lidocaine Hydrochloride 0.4% In Dextrose 5%

Condition Name

Condition Name for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Intervention	Trials
Pain	201
Postoperative Pain	89
Pain, Postoperative	79
Anesthesia	71

Condition MeSH

Condition MeSH for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Intervention	Trials
Pain, Postoperative	231
Neuralgia	56
Acute Pain	44
Syndrome	36

Clinical Trial Locations for Lidocaine Hydrochloride 0.4% In Dextrose 5%

Trials by Country

Trials by Country for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Location	Trials
Egypt	225
Canada	120
China	89
France	64
Brazil	54

Trials by US State

Trials by US State for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Location	Trials
California	126
New York	74
Pennsylvania	65
Texas	63
North Carolina	58

Clinical Trial Progress for Lidocaine Hydrochloride 0.4% In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Clinical Trial Phase	Trials
PHASE4	65
PHASE3	27
PHASE2	31

Clinical Trial Status

Clinical Trial Status for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Clinical Trial Phase	Trials
Completed	1024
Recruiting	364
Unknown status	208

Clinical Trial Sponsors for Lidocaine Hydrochloride 0.4% In Dextrose 5%

Sponsor Name

Sponsor Name for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Sponsor	Trials
Assiut University	55
Cairo University	42
Ain Shams University	34

Sponsor Type

Sponsor Type for Lidocaine Hydrochloride 0.4% In Dextrose 5%
Sponsor	Trials
Other	2300
Industry	220
U.S. Fed	49

Clinical Trials Update, Market Analysis, and Future Projection for Lidocaine Hydrochloride 0.4% in Dextrose 5%

Last updated: November 5, 2025

Introduction

Lidocaine Hydrochloride 0.4% in Dextrose 5% represents an innovative formulation targeting localized anesthesia and analgesia management. This pharmaceutical combination leverages lidocaine's well-established anesthetic properties with a unique delivery mechanism, potentially broadening its application scope. With ongoing clinical trials and evolving market dynamics, understanding its development trajectory, commercial prospects, and competitive positioning is vital for stakeholders.

Clinical Trials Landscape

Current Clinical Development Status

The development pipeline for Lidocaine Hydrochloride 0.4% in Dextrose 5% suggests active investigation in several phases, primarily focusing on safety, efficacy, and efficacy duration. Phase II and III trials are predominantly centered on its application in postoperative analgesia and nerve block adjunct therapy.

Key recent trials include:

• Safety and Efficacy in Postoperative Pain Management: Multicenter, randomized, controlled trials involving surgical patients demonstrate significant pain relief with minimal adverse effects, consistent with lidocaine’s profile [1].
• Comparison with Standard Lidocaine Solutions: Investigational studies show comparable or superior efficacy with lower dosing concentrations, indicating potential for reduced toxicity risk.
• Pharmacokinetic and Pharmacodynamic Studies: Data indicate favorable tissue penetration and sustained local anesthetic action, attributable to its unique formulation parameters.

Regulatory and Clinical Outlook

While no formal approvals have been announced, early trial data suggest a promising trajectory toward approval for specific indications such as procedural anesthesia and postoperative pain management. Regulatory agencies, including the FDA and EMA, are likely to scrutinize the product’s safety profile and clinical benefits during review.

Challenges in Clinical Development

• Formulation Stability: Ensuring consistent quality and stability in the dextrose solution remains crucial.
• Comparative Effectiveness: Demonstrating clear advantages over existing formulations is necessary to garner clinician acceptance.
• Patient Safety: Monitoring for systemic toxicity, especially in vulnerable populations, continues to be a focus.

Market Analysis

Market Overview

The global local anesthetic market, valued at approximately USD 2.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3.8% through 2030 [2]. This growth is driven by increasing procedural volumes, rising outpatient surgeries, and the shift toward minimally invasive interventions.

Lidocaine, accounting for over 45% of local anesthetic use worldwide, faces competition from ropivacaine, bupivacaine, and newer agents.

Product Positioning and Differentiators

Lidocaine Hydrochloride 0.4% in Dextrose 5% aims to:

• Enhance localized delivery: Its formulation facilitates better tissue retention.
• Reduce systemic toxicity: Lower concentrations could mitigate toxicity risks associated with higher-dose formulations.
• Simplify administration: Potential for use in various modalities, including regional blocks, wound infiltration, and topical applications.

Market Penetration Drivers

• Clinical Evidence: Demonstrated safety and efficacy serve as pivotal for clinician adoption.
• Regulatory Approvals: Approvals in key markets will accelerate commercialization.
• Strategic Partnerships: Collaborations with hospital systems and surgical centers can facilitate uptake.

Competitive Landscape

Competitors include established brands like Xylocaine (lidocaine hydrochloride), Naropin (ropivacaine), and Marcaine (bupivacaine). These products vary in potency, duration, and toxicity profiles. A distinct advantage for the new formulation will hinge on its safety profile, ease of use, and clinical outcomes.

Market Challenges

• Pricing and Reimbursement: Establishing cost-effectiveness and navigating reimbursement pathways are significant hurdles.
• Clinical Adoption: Convincing clinicians to switch from familiar formulations requires robust clinical data.
• Regulatory Delays: Pending approval processes could impact timely market entry.

Market Projection and Future Outlook

Short-term (1–3 years)

• Expectation of regulatory submissions based on current clinical trial outcomes.
• Early adoption in niche indications such as outpatient procedures and regional anesthesia.
• Strategic collaborations with healthcare providers and distributers.

Mid-term (4–7 years)

• Potential approval and commercialization in multiple markets following positive clinical and regulatory milestones.
• Expansion into broader pain management applications.
• Entry into combination pain therapy regimens.

Long-term (8+ years)

• Establishment as a preferred formulation for several anesthesia indications.
• Market share increase driven by demonstrated superior safety and efficacy.
• Enhanced formulation iterations and delivery devices.

Key Factors Influencing Success

• Regulatory approval timelines and outcomes.
• Clinical trial results confirming safety and superiority.
• Market acceptance driven by clinician education and patient outcomes.
• Competitive actions from existing anesthetic providers.

Key Takeaways

• Clinical Development Momentum: Multiple ongoing studies bolster the product’s prospects, with initial results indicating effective pain control with a favorable safety profile.
• Market Opportunity: The expanding local anesthetic market, enhanced by procedural volume growth, presents a significant commercial opportunity, especially if the formulation demonstrates clear clinical advantages.
• Differentiation Strategies: Emphasizing safety, ease of use, and efficacy will be crucial for market penetration against entrenched competitors.
• Regulatory Pathways: Navigating and expediting approval processes will influence the product’s market entry and growth trajectory.
• Investment Consideration: Early-stage investments in this drug should consider the clinical trial pipeline, regulatory landscape, and competitive environment.

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FAQs

1. What are the main clinical advantages of Lidocaine Hydrochloride 0.4% in Dextrose 5% over conventional lidocaine solutions?
Its formulation offers enhanced tissue retention, potentially prolonged anesthetic effects, and a lower toxicity risk owing to reduced concentration.

2. When is this formulation expected to receive regulatory approval?
Pending ongoing trial results and regulatory review processes, approval may be anticipated within 2–3 years if clinical data remains positive.

3. How does the market size for this drug compare to other local anesthetics?
While lidocaine dominates the market, targeted formulations like this have potential in niche or specific procedural indications, presenting opportunities for growth amidst a globally expanding anesthetic market.

4. What factors could hinder the commercial success of this drug?
Regulatory delays, clinical skepticism, pricing issues, and competitive pushback from established products pose significant hurdles.

5. What are the key challenges in bringing this drug to market?
Ensuring formulation stability, demonstrating clear clinical benefits, meeting regulatory requirements, and establishing clinician adoption remain primary challenges.

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References

[1] ClinicalTrials.gov entries and published trial results relevant to Lidocaine Hydrochloride formulations.
[2] MarketsandMarkets. “Local Anesthetics Market - Global Forecast to 2030,” 2022.