CLINICAL TRIALS PROFILE FOR HIBICLENS

505(b)(2) Clinical Trials for HIBICLENS

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
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).

All Clinical Trials for HIBICLENS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00513799 ↗	The Natural History of Community-Associated MRSA Infections and Decolonization Strategies	Completed	Washington University School of Medicine	N/A	2007-03-01	The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus. In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
NCT00731783 ↗	Staphylococcus Aureus Decolonization Study	Completed	Washington University School of Medicine	N/A	2008-07-01	The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
NCT00799812 ↗	Test for Pre Operative Skin Preparations	Completed	CareFusion	Phase 3	2007-11-13	Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	Cubist Pharmaceuticals LLC	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	East Tennessee State University	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	Mountain Home Research & Education Corporation	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01537783 ↗	Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess	Completed	Tufts Medical Center	Phase 4	2011-09-01	In this study, the investigators will enroll patients who present to the emergency department with abscesses to the study. The patients will be randomly selected to either have the standard of care, which includes the standard drainage of the abscess and then usually a follow-up visit to recheck the wound, or to have the standard of care plus instructions to use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily application of a topical antibiotic ointment called mupirocin to the nasal passages for five days. The investigators will then call back the patients at 7 days, 14 days (if in the treatment arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The study hypothesis is that the patients who have undergone the decontamination protocol will have fewer subsequent infections.

Clinical Trial Conditions for HIBICLENS

Condition Name

Condition Name for HIBICLENS
Intervention	Trials
Staphylococcal Skin Infections	3
Staphylococcus Aureus	3
Abscesses	2
Furunculosis	2

Condition MeSH

Condition MeSH for HIBICLENS
Intervention	Trials
Infections	7
Communicable Diseases	6
Staphylococcal Infections	5
Infection	5

Clinical Trial Locations for HIBICLENS

Trials by Country

Trials by Country for HIBICLENS
Location	Trials
United States	17

Trials by US State

Trials by US State for HIBICLENS
Location	Trials
Missouri	4
Maryland	2
Tennessee	2
Virginia	2
Pennsylvania	1

Clinical Trial Progress for HIBICLENS

Clinical Trial Phase

Clinical Trial Phase for HIBICLENS
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	9
Phase 3	1

Clinical Trial Status

Clinical Trial Status for HIBICLENS
Clinical Trial Phase	Trials
Completed	8
Recruiting	5
Unknown status	2

Clinical Trial Sponsors for HIBICLENS

Sponsor Name

Sponsor Name for HIBICLENS
Sponsor	Trials
Washington University School of Medicine	4
Johns Hopkins University	2
Cystic Fibrosis Foundation Therapeutics	1

Sponsor Type

Sponsor Type for HIBICLENS
Sponsor	Trials
Other	30
Industry	2
U.S. Fed	1

Last updated: July 27, 2026

Hibiclens clinical trials update, market analysis and revenue projection (2026-2035)

Executive summary: Hibiclens (chlorhexidine gluconate 4% topical antiseptic solution; generically sold as chlorhexidine gluconate 4% wash in multiple strengths) is a mature, low-cost Rx-to-OTC bridge antiseptic with limited “new-to-market” pipeline momentum. Near-term commercial growth is driven by hospital inventory cycles, infection-prevention protocols (surgical-site infection and MRSA coverage pathways), and retail treatment of minor skin infections under physician guidance. Patent-driven exclusivity is not a credible primary driver; the category competes on labeling, availability, supply reliability, and channel execution rather than brand differentiation.

Commercial view: Hibiclens-like chlorhexidine wash products are expected to grow in line with healthcare hygiene spend, with additional share gains possible where hospitals standardize pre-op skin preparation. The most material demand risks are formulation recalls, antiseptic stewardship shifts, payer formulary changes, and substitution toward alternative antiseptics in skin-cleansing protocols.

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What is Hibiclens and how is it regulated in the US (FDA status, labeling, pathway)?

Short answer: Hibiclens is a chlorhexidine gluconate 4% topical antiseptic marketed as a non-prescription (OTC) drug in consumer settings and as a hospital antiseptic product used in institutional infection prevention protocols. It is not a “clinical trial pipeline drug” in the way chronic therapeutics are; its regulatory strategy and commercialization center on established use labeling and product quality/CMC rather than new active ingredients.

What does the product label cover?

Typical US labeling for Hibiclens centers on:

• Preoperative skin preparation to reduce bacteria on the skin
• Use for minor skin conditions under medical direction
• Temporary reduction of bacteria on the skin prior to procedures

(Exact label wording is product-and-version dependent. The commercial analysis below uses the established chlorhexidine antiseptic market framework and the product’s known use profile.)

Is Hibiclens under the OTC Drug Facts framework or an NDA?

Hibiclens is regulated as a drug product with antiseptic active ingredient chlorhexidine gluconate; the commercial market behavior aligns with established antiseptic monographs/sections and legacy approvals rather than a late-stage NDA pipeline build.

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What clinical trials exist for Hibiclens (chlorhexidine gluconate 4%) and what is the latest update?

Short answer: Public clinical activity for chlorhexidine skin antisepsis remains dominated by protocol studies, head-to-head comparisons with povidone-iodine and other antiseptics, and studies of bathing regimens rather than “new Hibiclens clinical trials” with brand-defining endpoints. For a brand-level update, the practical conclusion is that ongoing activity usually supports clinical adoption of chlorhexidine-based pathways rather than introducing a new Hibiclens indication with meaningful regulatory milestones.

Trial categories most likely to affect Hibiclens demand

1. Surgical-site infection (SSI) prevention: pre-op skin preparation protocols using chlorhexidine washes.
2. MRSA and multidrug-resistant organism risk reduction: skin decolonization regimens where applicable.
3. Device- and procedure-associated infection pathways: cleansing prior to line placement and minor procedures.
4. Comparative antisepsis trials: chlorhexidine vs povidone-iodine, alcohol-based formulations, benzalkonium chloride, and iodine-based blends.

What changes in trial outcomes typically do for the market?

• Increased hospital formulary uptake when protocol committees see reduced SSI/MRSA signals or when compliance is higher for chlorhexidine-based standard orders.
• Reduced demand where stewardship bodies limit antiseptic use due to resistance concerns, skin irritation, or adherence problems.

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How does Hibiclens perform in the US market: sizing, channel mix, and key competitors?

Short answer: The chlorhexidine antiseptic wash space is crowded, with multiple branded and generic competitors, including store-brand chlorhexidine 4% washes, hospital private-label offerings, and alternative antiseptic products. Hibiclens’ advantage is usually brand recognition among clinicians and hospital procurement familiarity, not patent exclusivity.

Competitive landscape (practical substitutes)

• Generic chlorhexidine gluconate 4% topical antiseptic wash products
• Branded antiseptic skin-prep alternatives (non-chlorhexidine comparators) used in SSI protocols
• Institutional private-label chlorhexidine washes supplied through group purchasing organizations (GPOs)

Channel drivers

• Hospital procurement: standard-of-care protocols, bundled infection prevention initiatives
• Retail and e-commerce: episodic purchases and clinician-directed self-care following guidance
• Long-term care: bathing/decolonization protocols where instituted

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Which patents protect Hibiclens and does patent expiry matter for competition?

Short answer: Hibiclens competes primarily in a genericized chlorhexidine antiseptic environment. The active ingredient chlorhexidine gluconate is long off any core novelty period for antiseptic chemistry. Brand-level barriers are typically limited to product formulation details, packaging, process, and any remaining method-of-use or manufacturing patents, if any, but the category’s competitive reality is dominated by generics and private label.

How do you assess patent risk in practice?

For Hibiclens, patent-driven risk usually manifests as:

• Orange Book listings for specific NDA/ANDA product codes tied to Hibiclens labeling
• Litigation around formulation/process or trademark-related branding (rare for antiseptic chemistry)
• Label-change exclusivities rather than core compound exclusivity (if present)

Because chlorhexidine antiseptic demand is already served by multiple products, even a “patent-protected brand” often has limited ability to stop substitution in practice.

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When does Hibiclens lose exclusivity and what generic entry risks exist?

Short answer: Generic entry risk is structurally high in this category because chlorhexidine gluconate 4% wash is widely available from generics and private-label supply. The most realistic “entry barrier” is not compound exclusivity, but:

• Ability to obtain compliant manufacturing and distribution at scale
• Ability to support labeling consistent with hospital protocol requirements
• Contracting with GPOs and pharmacy benefit structures

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What is the Orange Book status of Hibiclens (and which ANDAs could substitute)?

Short answer: Hibiclens’ competitive substitution is expected to be driven by the availability of chlorhexidine gluconate 4% wash ANDAs and private-label products. The practical Orange Book relevance is whether Hibiclens has any listed patents tied to a specific listed drug and whether they remain enforceable. In a generic environment, multiple ANDAs exist with label-compatible antiseptic claims.

(An Orange Book listing table with patent numbers and expiry dates cannot be produced without source-specific product-identification fields for the exact Hibiclens listed drug and strength configuration.)

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How strong is the patent estate for Hibiclens compared with alternative antiseptics?

Short answer: Chlorhexidine antiseptic products are typically not protected by a large, enforceable modern patent thicket around the active ingredient, and the market does not price antiseptic washes as an innovation monopoly. Relative advantage usually comes from supply reliability and channel positioning, not enforceable exclusivity.

Practical implications for brand strategy

• Litigation is less likely to be the main competitive lever than procurement wins.
• Differentiation focuses on procurement readiness, package convenience, and clinician/prescriber habits.

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How does Hibiclens compare with competing antiseptics (povidone-iodine and others) in adoption drivers?

Short answer: Hospital protocol committees decide antiseptic selection on:

• SSI and colonization reduction evidence in specific settings
• Skin tolerability and irritation profile
• Ease of compliance and workflow fit
• Supply chain reliability and cost per use

Chlorhexidine is often favored in many SSI protocols due to its antiseptic performance and compatibility with standard pre-op workflows.

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What revenue projection range is reasonable for Hibiclens (2026-2035 base case)?

Short answer: Without a brand-level historical revenue series and without a specific US market share allocation for Hibiclens, a defensible projection must be expressed as a scenario band tied to category dynamics. The expected growth is moderate, driven by institutional infection prevention standardization and incremental retail replenishment.

Scenario-based projection framework (US-centric, demand-side drivers)

Base case drivers

• Ongoing infection prevention spending
• Continued chlorhexidine protocol standardization where clinical committees support it
• Replacement purchases sustaining distribution and shelf stability

Downside drivers

• Protocol shifts toward alternative antiseptics in subsets of hospitals
• Supply disruptions impacting hospital formulary continuity
• Increased adverse event concerns leading to restricted use in certain dermatologic contexts

Upside drivers

• Higher adoption in SSI bundles and post-op wound cleansing protocols
• Expanded guideline alignment and clinician education campaigns

Projection band (directional)

• 2026-2030: Mid-single-digit demand growth for chlorhexidine wash category; Hibiclens likely grows at or slightly below category if generics sustain share.
• 2031-2035: Low- to mid-single-digit growth assuming stable institutional protocols and steady retail replenishment, with erosion if alternative antiseptics gain protocol share.

This is a category-driven model; Hibiclens brand growth depends on maintaining hospital contracts, GPO positioning, and avoiding supply disruptions.

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What market risks matter most for Hibiclens (pricing, procurement, safety, supply chain)?

Short answer: For an antiseptic wash brand, the largest commercial risks are not blockbuster-style FDA label exclusivity shifts. They are procurement economics, supply reliability, safety/skin tolerability events, and protocol substitution.

Key risk list

1. Procurement price compression from generic competition and private-label chlorhexidine.
2. Formulary changes at the hospital committee level.
3. Labeling or stewardship shifts that reduce recommended frequency or scope.
4. Skin irritation and tolerability prompting restricted use in dermatology-heavy cohorts.
5. Quality or manufacturing incidents causing temporary distribution gaps.

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Key takeaways

• Hibiclens is a mature chlorhexidine gluconate 4% antiseptic where clinical activity tends to support protocol adoption, not brand-defining “new drug” development.
• The competitive threat is primarily generics and private label in chlorhexidine wash, not patent expiry-driven entry timing.
• Market growth is expected to track hospital infection prevention spend and SSI protocol adherence, with moderate upside from protocol standardization and downside from antiseptic substitution and price compression.
• Revenue projection for Hibiclens is best modeled as a scenario band tied to category demand rather than a patent-protection ramp.

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FAQs

1) Are there any “new indications” for Hibiclens in clinical trials?
Most public clinical activity in chlorhexidine skin antisepsis supports protocol-level use rather than brand-new Hibiclens indications.

2) Does Hibiclens have major FDA exclusivity that blocks generics?
In practice, chlorhexidine 4% wash is widely available; competition is dominated by generics and private label rather than exclusivity barriers.

3) What antiseptic is most comparable to Hibiclens for pre-op skin prep?
Povidone-iodine and other antiseptic skin-prep regimens are the most common protocol comparators used in clinical studies and guideline discussions.

4) How do hospital protocols influence Hibiclens demand?
Hospital SSI bundles and standard-of-care skin preparation orders drive repeat procurement, often outweighing retail demand.

5) What non-patent factors most affect Hibiclens market share?
Contracting with GPOs, purchasing agreements, supply reliability, and clinician familiarity typically dominate share outcomes.

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References

1. US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-27).
2. US FDA. Drug Trials Snapshots. (Accessed 2026-07-27).
3. CDC. Guideline and infection prevention resources for surgical site infection prevention and antisepsis. (Accessed 2026-07-27).