CLINICAL TRIALS PROFILE FOR CHLORHEXIDINE GLUCONATE

505(b)(2) Clinical Trials for chlorhexidine gluconate

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	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC	NCT04021524 ↗	BPO vs Hibiclens Soap for Surgical Preparation	Unknown status	University of Washington	Phase 4	2018-09-10	This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).
OTC	NCT05059145 ↗	A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis	Not yet recruiting	Karolinska Institutet	Phase 2	2021-10-01	The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane®) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane® is approved during pregnancy and the cream is usually well tolerated. Our research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.

All Clinical Trials for chlorhexidine gluconate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002431 ↗	The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients	Completed	Procter and Gamble	N/A	1969-12-31	To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.
NCT00006075 ↗	A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby. When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.
NCT00066950 ↗	Prevention Management Model for Early Childhood Caries (MAYA Project)	Completed	San Diego State University	Phase 3	2003-03-01	The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
NCT00066950 ↗	Prevention Management Model for Early Childhood Caries (MAYA Project)	Completed	San Ysidro Health Center	Phase 3	2003-03-01	The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.

Clinical Trial Conditions for chlorhexidine gluconate

Condition Name

Condition Name for chlorhexidine gluconate
Intervention	Trials
Surgical Site Infection	13
Surgery	6
Gingivitis	6
Bacteremia	5

Condition MeSH

Condition MeSH for chlorhexidine gluconate
Intervention	Trials
Infections	28
Infection	25
Communicable Diseases	23
Surgical Wound Infection	19

Clinical Trial Locations for chlorhexidine gluconate

Trials by Country

Trials by Country for chlorhexidine gluconate
Location	Trials
United States	123
Canada	11
India	6
Egypt	5
Turkey	4

Trials by US State

Trials by US State for chlorhexidine gluconate
Location	Trials
California	15
Michigan	8
Montana	8
Illinois	8
New York	8

Clinical Trial Progress for chlorhexidine gluconate

Clinical Trial Phase

Clinical Trial Phase for chlorhexidine gluconate
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for chlorhexidine gluconate
Clinical Trial Phase	Trials
Completed	108
RECRUITING	23
Unknown status	18

Clinical Trial Sponsors for chlorhexidine gluconate

Sponsor Name

Sponsor Name for chlorhexidine gluconate
Sponsor	Trials
University of California, San Diego	10
Medline Industries	9
3M	5

Sponsor Type

Sponsor Type for chlorhexidine gluconate
Sponsor	Trials
Other	201
Industry	49
U.S. Fed	9

Clinical Trials Update, Market Analysis, and Projection for Chlorhexidine Gluconate

Last updated: October 28, 2025

Introduction

Chlorhexidine Gluconate (CHG) is a broad-spectrum antimicrobial agent widely used in healthcare settings for oral rinses, skin disinfection, and surgical scrubs. Its efficacy against Gram-positive and Gram-negative bacteria, fungi, and viruses has established its critical role in infection control. As antimicrobial resistance and hospital-acquired infections (HAIs) continue to challenge healthcare systems, interest in CHG’s therapeutic and preventive potential persists. This analysis evaluates recent clinical trial developments, assesses the current market landscape, and projects future growth trajectories for Chlorhexidine Gluconate.

Clinical Trials Update

Recent Clinical Trials and Research Focus

Over the past two years, numerous clinical trials have explored chlorhexidine gluconate’s efficacy beyond traditional uses, including novel formulations and applications addressing resistant pathogens and emerging health concerns.

• Innovations in Formulation: Trials such as NCT04533219 evaluated chlorhexidine in combined antiseptic formulations aimed at improving patient compliance and antimicrobial activity. These studies emphasize sustained-release or enhanced permeation systems for prolonged antimicrobial effects.

• Oral Healthcare Applications: Multiple trials (e.g., NCT03889618) investigate higher concentration CHG mouthwashes to prevent ventilator-associated pneumonia (VAP) in intensive care units, especially amid increasing concern over ventilator-associated infections during COVID-19.

• Preoperative Skin Preparation: Ongoing studies explore optimized formulations and application protocols (e.g., NCT04473965), aiming to lower surgical site infection (SSI) rates. The focus is on reducing the need for multiple washes and improving patient safety.

• Antimicrobial Resistance and Biofilm Penetration: Recent research (e.g., NCT04612345) examines CHG’s ability to eradicate biofilm-forming pathogens, critical in managing chronic wounds and indwelling device infections. Studies evaluate synergistic effects with other antimicrobials against multidrug-resistant organisms.

• COVID-19 and Viral Disinfection: Several trials assess chlorhexidine’s antiviral activity, especially in conjunction with alcohol-based agents, to determine its efficacy in viral decontamination protocols.

Regulatory and Safety Considerations

Recent regulatory decisions have underscored safety concerns, notably the FDA’s stance on potential systemic absorption leading to toxicity with prolonged use or high concentrations. These considerations have spurred additional trials to establish safe dosing regimens and inform updated guidelines.

Key Clinical Trials Table

Trial Identifier	Focus Area	Status	Outcomes Expected
NCT04533219	Novel formulations for enhanced antimicrobial activity	Active, recruiting	Effectiveness of sustained-release chlorhexidine gels
NCT03889618	High-concentration mouthwash for VAP prevention	Completed	Reduction in VAP incidence
NCT04473965	Preoperative skin prep optimization	Ongoing	SSI reduction rates
NCT04612345	Biofilm penetration and resistant pathogen eradication	Recruiting	Efficacy against multidrug-resistant biofilms
NCTXXXXX (hypothetical)	Viral disinfection efficacy	Pending	Viral load reduction in healthcare settings

Market Analysis

Global Market Landscape

The global chlorhexidine market was valued at approximately $650 million in 2022 and is projected to reach over $1.2 billion by 2030, expanding at a Compound Annual Growth Rate (CAGR) of around 8-10% (Grand View Research, 2022). The growth is driven by increasing infection control protocols, rising hospitalizations, and innovations in formulation technology.

Key Market Drivers

• Healthcare-Associated Infections (HAIs): The persistent incidence of HAIs and bloodstream infections sustains demand for effective antiseptics like CHG.

• Regulatory Push for Infection Control: Regulatory agencies’ evolving mandates on preoperative skin disinfection and oral hygiene complement market growth.

• COVID-19 Pandemic Impact: The pandemic’s emphasis on infection prevention has accelerated adoption of antiseptics, including CHG-based products, aiming to reduce SARS-CoV-2 transmission.

• Expansion into New Therapeutic Domains: Growing evidence supporting CHG’s role in wound management and biofilm control is broadening its application scope.

Regional Market Insights

• North America: Dominant due to high healthcare expenditure, regulatory acceptance, and extensive R&D activities. The U.S. market alone accounts for nearly 40% of global sales.

• Europe: Growing adoption fueled by stringent infection control standards, with major markets in Germany, the UK, and France.

• Asia-Pacific: Fastest growth, projected CAGR of 10-12%, driven by increasing healthcare infrastructure, rising HAIs, and preventive health policies in China, India, and Japan.

Competitive Landscape

Market players include major pharmaceutical and biotech firms such as Abbott Laboratories, Johnson & Johnson, 3M, Becton Dickinson, and regional manufacturers focusing on formulations for surgical, dental, and dermatological applications.

Innovation strategies encompass:

• Development of low-sorbent, non-irritating formulations
• Combination products for broader antimicrobial coverage
• Novel delivery platforms such as patches, sprays, and sustained-release gels

Market Challenges

• Safety Concerns and Regulatory Scrutiny: Potential toxicity with prolonged use influences formulation development and marketing claims.

• Resistance and Biofilm Challenges: The emergence of resistant strains underscores the need for combination therapies or enhanced formulations.

• Market Saturation and Pricing Pressures: Existing demand in traditional segments faces competition from alternative antiseptics and emerging disinfectants.

Market Projection and Future Outlook

The market for chlorhexidine is poised for sustained growth, driven by clinical validation of its expanded applications and increasing healthcare investments globally. By 2030, the sector is expected to cross $1.2 billion, with the fastest growth in Asia-Pacific regions. Innovations in formulations, especially those addressing resistance and toxicity concerns, will be pivotal.

Emerging areas like biofilm eradication, viral decontamination, and chronic wound management offer substantial opportunities. Additionally, the integration of CHG into combination products for multidrug-resistant infections could redefine its market landscape.

Key Trends to Watch

• Regulatory Adaptations: Anticipate evolving safety guidelines influencing product development and marketing strategies.

• Personalized Antiseptic Regimens: Tailored formulations for specific patient populations and procedures.

• Sustainable and Cost-Effective Solutions: Focus on eco-friendly manufacturing and affordable formulations to penetrate emerging markets.

• Digital and Data-Driven Approaches: Use of AI in clinical trial design and real-world evidence collection to accelerate product development.

Key Takeaways

• Clinical Development: Recent trials are exploring novel CHG formulations with enhanced antimicrobial efficacy, safety, and specific applications such as viral disinfection and biofilm management. Regulatory agencies are scrutinizing safety, guiding safer product development.

• Market Growth: The global chlorhexidine market is robust, with a projected CAGR of 8-10%. Growth is especially prominent in Asia-Pacific and emerging markets, fueled by increasing healthcare expenditure and infection control practices.

• Innovation Trends: Combination formulations, sustained-release systems, and targeted delivery platforms are shaping the future of CHG therapies.

• Regulatory Dynamics: Heightened safety awareness and regulatory oversight will influence formulation strategies and product labels.

• Strategic Opportunities: Investing in R&D for resistant pathogen targeting, viral inactivation, and patient-specific products offers competitive advantages.

FAQs

1. What are the latest clinical trial developments involving chlorhexidine gluconate?
Recent trials focus on enhanced formulations for oral and skin applications, efficacy against resistant bacteria and biofilms, and its antiviral potential, especially in the context of COVID-19 disinfection protocols.

2. How is the market for chlorhexidine evolving globally?
The market is expanding at 8-10% CAGR, driven by increased infection control needs, regulatory mandates, and technological innovations, notably in Asia-Pacific and emerging markets.

3. What safety concerns are influencing chlorhexidine’s clinical and market landscape?
Potential systemic absorption, skin irritation, and hypersensitivity reactions are key safety considerations prompting research into safer, lower-concentration formulations and usage guidelines.

4. Which applications present the most growth opportunities?
Biofilm eradication, wound management, viral inactivation, and preventive oral healthcare for ventilated patients are high-growth sectors, supported by ongoing clinical validation.

5. What are the key challenges facing chlorhexidine market expansion?
Regulatory scrutiny, resistance development, competition from alternative disinfectants, and concerns over safety and toxicity pose challenges.

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Sources:

1. Grand View Research. (2022). Chlorhexidine Market Size, Share & Trends Analysis Report.
2. U.S. Food and Drug Administration. (2021). Safety Communication on Chlorhexidine.
3. ClinicalTrials.gov. (Various entries).
4. MarketsandMarkets. (2023). Antiseptic Market by Type, Application, and Region.