Last Updated: June 27, 2026

CLINICAL TRIALS PROFILE FOR CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL


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505(b)(2) Clinical Trials for Chlorhexidine Gluconate; Isopropyl Alcohol

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Chlorhexidine Gluconate; Isopropyl Alcohol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00247897 ↗ Comparing Skin Disinfectants Before Labour Epidural Analgesia Completed University of British Columbia N/A 2005-11-01 The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.
NCT00739583 ↗ Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions Completed Johns Hopkins University Phase 4 2008-08-01 Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.
NCT00829023 ↗ Efficacy of Surgical Preparation Solutions in Shoulder Surgery Completed CareFusion N/A 2007-06-01 The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
NCT00829023 ↗ Efficacy of Surgical Preparation Solutions in Shoulder Surgery Completed Northwestern University N/A 2007-06-01 The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chlorhexidine Gluconate; Isopropyl Alcohol

Condition Name

Condition Name for Chlorhexidine Gluconate; Isopropyl Alcohol
Intervention Trials
Breast Surgery 3
Anesthesia, Local 2
Surgical Site Infection 2
Trauma Injury 2
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Condition MeSH

Condition MeSH for Chlorhexidine Gluconate; Isopropyl Alcohol
Intervention Trials
Acute Pain 3
Infections 3
Communicable Diseases 3
Pain, Postoperative 3
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Clinical Trial Locations for Chlorhexidine Gluconate; Isopropyl Alcohol

Trials by Country

Trials by Country for Chlorhexidine Gluconate; Isopropyl Alcohol
Location Trials
United States 17
Canada 3
United Kingdom 1
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Trials by US State

Trials by US State for Chlorhexidine Gluconate; Isopropyl Alcohol
Location Trials
California 7
Pennsylvania 2
Illinois 2
Wisconsin 1
Florida 1
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Clinical Trial Progress for Chlorhexidine Gluconate; Isopropyl Alcohol

Clinical Trial Phase

Clinical Trial Phase for Chlorhexidine Gluconate; Isopropyl Alcohol
Clinical Trial Phase Trials
Phase 4 12
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Chlorhexidine Gluconate; Isopropyl Alcohol
Clinical Trial Phase Trials
Completed 12
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Chlorhexidine Gluconate; Isopropyl Alcohol

Sponsor Name

Sponsor Name for Chlorhexidine Gluconate; Isopropyl Alcohol
Sponsor Trials
University of California, San Diego 9
Northwestern University 2
McLaren Health Care 1
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Sponsor Type

Sponsor Type for Chlorhexidine Gluconate; Isopropyl Alcohol
Sponsor Trials
Other 26
Industry 4
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Last updated: May 24, 2026

Clinical Trials Update, Market Analysis, and Forecast for Chlorhexidine Gluconate + Isopropyl Alcohol (Topical Antiseptic) Products

Chlorhexidine gluconate (CHG) plus isopropyl alcohol (IPA) is a widely used topical antiseptic combination, marketed globally in prefilled applicators and skin-cleansing formats. The drug’s near-term growth is driven by hospital adoption for pre-procedural skin preparation and device-related infection prevention protocols, but the commercial ceiling is shaped by (1) formulary competition versus alternative antiseptics (povidone-iodine, benzalkonium chloride blends, octenidine), (2) supply and manufacturing complexity for fixed-dose combination applicators, and (3) pricing pressure as multiple generic and private-label offerings expand.

No patent-by-patent exclusivity and no FDA Orange Book–style proprietary status can be produced from the information provided in this thread. Likewise, no credible “clinical trials update” can be completed without specific trial IDs, registries, sponsors, geographies, and endpoints.

What clinical trials exist for chlorhexidine gluconate + isopropyl alcohol (CHG/IPA) skin antisepsis?

What is the typical clinical evidence base

CHG/IPA products are usually supported by:

  • randomized trials or pragmatic hospital studies assessing skin decolonization or bacterial burden reduction after pre-procedure cleansing
  • catheter- or surgical-site infection prevention studies embedded in broader infection-control bundles
  • comparative effectiveness studies against povidone-iodine or CHG alone

Clinical programs are often operational rather than “development-stage,” with evidence generated as label-support and post-marketing hospital outcomes rather than new chemical entity trials.

What endpoints are most often used

  • time-to-reduction in colony counts (log reduction) on skin
  • incidence of surgical site infection (SSI) or catheter-related bloodstream infection (CRBSI)
  • microbiologic contamination or persistence after application
  • tolerability and skin irritation measures

Where new trials typically concentrate

  • high-acuity hospital environments (ICU, perioperative, central-line insertion workflows)
  • special populations that are protocol-sensitive (orthopedics, vascular access, oncology procedure pathways)
  • operational studies focused on adherence, usability, and time-to-application rather than new clinical biology

What is the current market landscape for chlorhexidine gluconate + isopropyl alcohol (CHG/IPA) antiseptics?

Core commercial use cases

  • preoperative skin preparation and perioperative antisepsis
  • pre-injection or pre-procedural skin cleansing in clinical settings
  • device insertion workflows (central venous catheter, dialysis access preparation)
  • outbreak mitigation protocols for infection prevention teams

Competitive set

CHG/IPA competes against:

  • CHG-only formulations (washes, wipes, applicators)
  • povidone-iodine solutions and swabs
  • alternative antiseptic chemistries (including quaternary ammonium compounds and octenidine in some markets)
  • combination wipes and pre-soaked products under private label and generic supply chains

Buying drivers

  • infection-prevention guideline alignment (CDC or local hospital bundle protocols)
  • formulary adoption by ID and infection control committees
  • product usability (wipe vs applicator, time-to-dry, workflow fit)
  • cost per use under group purchasing organization (GPO) or hospital contract frameworks
  • availability and supply reliability

How fast does the chlorhexidine gluconate + isopropyl alcohol market grow, and what drives adoption?

Market growth equation (practical view)

Growth is usually a function of:

  • procedure volume growth (surgery and invasive device placements)
  • infection prevention bundle penetration
  • compliance with standardized skin antisepsis workflows
  • substitution away from older antiseptics due to efficacy perceptions and institutional experience
  • reimbursement and procurement dynamics

Growth constraints

  • price compression as supply expands
  • substitution pressure from CHG-only and alternative antiseptics where budgets tighten
  • adverse event and skin tolerability management requirements for alcohol-containing products in sensitive patient groups
  • manufacturing capacity and QA variability for fixed-dose applicators

Forecast sensitivity

The forecast is most sensitive to:

  • hospital procurement contract resets (often 12 to 24 months)
  • formulary decisions after infection-control committee reviews
  • country-level antimicrobial stewardship and infection prevention guideline updates
  • supply chain disruptions affecting alcohol or CHG sourcing

When do chlorhexidine gluconate + isopropyl alcohol products lose exclusivity or face generic entry risk?

What exclusivity risk typically looks like for antiseptic combinations

For antiseptics that are widely supplied, generic entry is commonly driven by:

  • formulation-level equivalence and manufacturing scale rather than classic “new chemical entity” exclusivity
  • label and method-of-use positioning where clinical differentiation is less about a single patent and more about procurement and workflow fit

What can and cannot be stated here

A precise exclusivity timeline, including Orange Book listings, patent expiration dates, and Paragraph IV risk windows, cannot be produced from the current prompt. No drug-specific registration, product strength, dosage form, NDC, or FDA application identifiers were provided.

What is the Orange Book status of chlorhexidine gluconate + isopropyl alcohol products?

A product-level Orange Book status requires at minimum:

  • FDA application number(s) or NDC listing(s)
  • proprietary product names and strength/dosage form

Those details are not present, so a table of listed patents, expiration dates, and exclusivity periods cannot be generated.

Which companies are active in chlorhexidine gluconate + isopropyl alcohol, and how do they compete?

How the market organizes

  • originator or branded hospital antiseptic suppliers competing on clinical trust and procurement contracts
  • generic and private-label manufacturers competing on supply, cost, and contract pricing
  • distributors and GPO channels acting as gatekeepers for formulary access

What determines share

  • contract price per use (not list price)
  • contract renewals tied to infection-prevention KPI tracking
  • product availability and lead times
  • clinician and nursing workflow usability

How strong is the patent estate for chlorhexidine gluconate + isopropyl alcohol antiseptic combinations?

A patent-strength score requires:

  • a defined product identity (CHG concentration, IPA concentration, formulation type, applicator/wipe format)
  • jurisdiction set (US, EU, UK, etc.)
  • known patents and assignees

No patent dataset was provided in the prompt, so patent strength cannot be quantified without fabricating.

What formulation and manufacturing/IP barriers affect chlorhexidine gluconate + isopropyl alcohol competition?

Typical formulation considerations

  • CHG stability in alcoholic media
  • residual solvent profile and shelf-life under temperature cycling
  • applicator performance (impregnation consistency, release efficiency on skin)
  • skin irritation profile balancing CHG activity and alcohol tolerability

Typical manufacturing and regulatory constraints

  • validated mixing and filtration steps for consistency
  • packaging integrity to maintain concentration over shelf-life
  • microbial limits and sterility assurance policies where applicable
  • regulatory compliance for labeling, instructions for use, and patient population contraindications

Regulatory positioning: how do chlorhexidine gluconate + isopropyl alcohol products get approved and maintained?

Regulatory categories that commonly apply

In many markets, antiseptics are regulated as:

  • OTC drug products (where permitted) or regulated antiseptic preparations
  • hospital/medical use products with specific labeled indications and instructions

What drives label maintenance

  • adverse event reporting trends and skin irritation signals
  • stability data updates
  • changes in packaging or manufacturing site (post-approval changes)
  • strengthening of infection prevention language in line with guideline updates

Commercial projection: base case, bear case, bull case

Base case (most likely procurement-led outcome)

  • Continued hospital adoption in perioperative and device-insertion workflows
  • Share held by cost-competitive suppliers and contract winners
  • Growth tracks procedure volume and infection prevention bundle compliance

Bear case (pricing and substitution pressure)

  • increased substitution toward CHG-only or alternative antiseptics under budget constraints
  • price compression as generic or private-label offerings expand
  • slower adoption in non-acute settings

Bull case (bundle expansion and better adherence)

  • stronger guideline alignment and measured infection reduction improves purchasing confidence
  • contract wins tied to outcomes tracking expand usage frequency
  • expanded institutional policies for broader pre-procedure coverage

Market model template (for internal forecasting)

Driver Measurement Base case Bear case Bull case
Procedure volume surgeries, invasive device placements + + +
Bundle penetration % facilities using standardized skin prep protocols steady slower faster
Price per unit contract price down moderately down sharply down moderately
Share of antisepsis shelf CHG/IPA vs alternatives steady declines improves
Supply continuity lead times and allocations stable disruptions stable

Key Takeaways

  • CHG/IPA is a mature antiseptic combination with demand tied to hospital infection prevention workflows rather than novel clinical endpoints.
  • Market growth is constrained mainly by procurement-driven price competition and substitution among alternative antiseptics.
  • A precise clinical trials update and patent/exclusivity timeline cannot be produced from the information in this prompt because no product identifiers, FDA application references, registries, or trial IDs were provided.

FAQs

  1. What indications are typically labeled for chlorhexidine gluconate + isopropyl alcohol skin antisepsis products?
  2. How do CHG/IPA wipes or applicators compare with povidone-iodine for surgical site infection outcomes?
  3. What are the key tolerability risks of alcohol-containing CHG products, and how do hospitals manage them?
  4. What procurement metrics do hospitals use to choose between CHG/IPA and alternative antiseptics?
  5. How does contract pricing and GPO participation affect market share for CHG/IPA antiseptics?

References

  1. No sources were provided in the prompt; no citations can be generated without external document inputs.

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