CLINICAL TRIALS PROFILE FOR ISOPROPYL ALCOHOL

505(b)(2) Clinical Trials for 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.

All Clinical Trials for 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.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Medical College of Wisconsin	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Michael Debakey Veterans Affairs Medical Center	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Michael E. DeBakey VA Medical Center	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	US Department of Veterans Affairs	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	VA Office of Research and Development	Phase 3	2003-09-01	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

Clinical Trial Conditions for isopropyl alcohol

Condition Name

Condition Name for isopropyl alcohol
Intervention	Trials
Nausea	5
Surgical Site Infection	4
Anesthesia, Local	3
Breast Surgery	3

Condition MeSH

Condition MeSH for isopropyl alcohol
Intervention	Trials
Infections	7
Communicable Diseases	6
Surgical Wound Infection	5
Acute Pain	4

Clinical Trial Locations for isopropyl alcohol

Trials by Country

Trials by Country for isopropyl alcohol
Location	Trials
United States	40
Canada	8
Thailand	1
United Kingdom	1
Italy	1

Trials by US State

Trials by US State for isopropyl alcohol
Location	Trials
California	10
Texas	7
Florida	5
Illinois	3
Montana	3

Clinical Trial Progress for isopropyl alcohol

Clinical Trial Phase

Clinical Trial Phase for isopropyl alcohol
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	19

Clinical Trial Status

Clinical Trial Status for isopropyl alcohol
Clinical Trial Phase	Trials
Completed	30
Recruiting	10
Not yet recruiting	7

Clinical Trial Sponsors for isopropyl alcohol

Sponsor Name

Sponsor Name for isopropyl alcohol
Sponsor	Trials
University of California, San Diego	10
University of Florida	3
University of British Columbia	3

Sponsor Type

Sponsor Type for isopropyl alcohol
Sponsor	Trials
Other	56
Industry	12
U.S. Fed	6

Last updated: May 20, 2026

Isopropyl Alcohol Clinical Trials Update, Market Analysis and Projections (2024-2035)

Executive summary

Isopropyl alcohol (IPA) is an over-the-counter (OTC) topical antiseptic and common solvent used in healthcare and industrial applications. It is not an FDA “drug” in the sponsor-led, regulated-drug sense that produces an Orange Book patent estate or NDA/BLA exclusivity. Current clinical-trials visibility is dominated by formulation comparisons (skin antisepsis, wound care, pre-injection/hand hygiene protocols), not by novel IPA molecular entities. Market growth is driven by hygiene demand cycles, antimicrobial claims validation for fixed concentrations and contact times, and substitution away from ethanol in supply-constrained periods. The most investable line items are: (i) regulated manufacturing of IPA-based antiseptic products (OTC monographs and/or NDA supplements depending on product claims), (ii) contract manufacturing for healthcare wipes/gels, and (iii) industrial-grade IPA where solvent demand and feedstock spreads drive profitability.

No single “isopropyl alcohol” brand trial program controls outcomes; the competitive landscape is product-formulation and delivery-device dependent, not active-ingredient dependent.

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What clinical trials are running for isopropyl alcohol right now?

What exists in practice: Most “isopropyl alcohol” trials are small interventional or observational studies that test:

• antiseptic efficacy of specific IPA concentrations (commonly 60% to 70% v/v) and contact times,
• comparative performance versus ethanol, chlorhexidine, povidone-iodine, benzalkonium chloride, or quaternary ammonium compounds,
• procedural outcomes in clinical workflows (hand hygiene adherence, pre-procedural skin prep, catheter insertion prep),
• compatibility and performance of IPA in wipes, gels, sprays, and skin barriers.

Featured snippet answer: The trial footprint for IPA is typically protocol- and formulation-specific rather than “new IPA drug” development. Trial endpoints center on microbial reduction, culture conversion, or standardized antisepsis test frameworks.

Where do trial datasets show up most

• Antisepsis and surgical site infection (SSI) prevention workflows (pre-op skin prep comparators, catheter-site prep).
• Hand hygiene and healthcare-associated infection (HAI) prevention studies using IPA-based gels or wipe systems.
• Wound care adjunct studies assessing decontamination or surface sterilization effects when used in combination with dressings.

Key endpoints used

• log reduction of defined organisms after a timed application,
• culture negativity rates at set timepoints,
• standardized skin bioburden reduction models,
• user workflow time-to-dry and irritation scores (for patient/clinician acceptance),
• device compatibility (wipe integrity, gel viscosity retention, spray plume consistency).

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Which ongoing trials for isopropyl alcohol are most likely to change commercial demand?

Commercially relevant trials are those that:

• validate a clinically meaningful concentration and contact time for a specific delivery system (wipe, gel, spray),
• support label language that improves formulary adoption in hospitals and long-term care,
• generate evidence that reduces irritation or increases usability versus ethanol-based alternatives,
• confirm performance under realistic soiling conditions (organic load).

Featured snippet answer: Trial impact tracks formulation and claim language, not IPA’s intrinsic antimicrobial mechanism, because IPA is already widely established.

High-impact trial patterns

• Comparative arms using IPA concentration bands (example pattern: 70% v/v IPA vs 70% ethanol vs mixed actives).
• Studies embedded in insertion and procedure bundles (catheters, IV access, surgical skin prep).
• Human-use tolerability work that enables broader institutional procurement.

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How does isopropyl alcohol market demand break out by application?

Core demand drivers:

1. Healthcare antiseptics and disinfectant products
   • hand rubs/gels
   • wipes
   • pre-procedural skin prep products
2. Industrial solvents
   • paints and coatings intermediates
   • electronics cleaning
   • chemical manufacturing solvent/feedstock
3. Pharmaceutical and personal care supply chain
   • solvent in excipient and intermediate production
   • processing solvent in manufacturing environments

Featured snippet answer: Antiseptic demand is the demand-sensitive segment tied to hygiene cycles and procurement rules; industrial demand is spread-driven based on propylene-to-IPA economics and downstream solvent demand.

Where margins concentrate

• Healthcare-ready IPA-based formulations often carry higher value per liter than bulk industrial IPA, but depend on formulation complexity, QA, packaging, and labeling compliance.
• Industrial IPA margin follows feedstock costs and contract pricing with buyers in electronics cleaning and coatings.

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What is the current isopropyl alcohol supply situation and why does it matter for pricing?

Price formation factors for IPA:

• propylene supply tightness and refinery/chemical plant utilization,
• aromatics and co-product economics in propylene processing,
• global logistics constraints and regional inventories,
• substitution between IPA and ethanol depending on availability and regulatory acceptability.

Featured snippet answer: Market pricing is most sensitive to feedstock economics and utilization rates in IPA plants, which can move wholesale costs faster than OTC healthcare demand can rebalance.

Risk to projectable demand

• If industrial demand softens, surplus can spill into healthcare-grade supply, pressuring formulation margins.
• If healthcare demand accelerates (seasonal peaks, outbreak-driven procurement), healthcare formulation producers may absorb cost swings if they cannot pass through pricing quickly.

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How big is the isopropyl alcohol market and what’s the forecast to 2035?

Forecast framing that is actionable: IPA is a commodity with cycles, so the best projection approach is to forecast application-specific volumes rather than a single “drug-like” S-curve.

Featured snippet answer: The long-range growth profile is steady-single-digit for mature markets, with faster growth in hygiene product penetration and electronics and personal care solvent uses depending on regional industrial expansion.

Projection structure (volume and value)

• Healthcare antiseptics:
  • growth tied to facility infection control adoption, wipe and gel penetration, and label expansion.
• Industrial solvents:
  • growth tied to electronics and coatings cycles.
• Pharmaceutical processing:
  • growth tied to manufacturing capacity expansion and outsourcing of intermediates.

Scenario bands (for investment modeling)

• Base case: steady demand, moderate pass-through, low volatility after normalization.
• Upside case: prolonged hygiene procurement and faster substitution to IPA in ethanol-constrained markets.
• Downside case: industrial slowdown with inventory pressure and margin compression in formulations.

(Industry-wide numeric projections require market-research data and region splits that are not provided here; this response focuses on decision-grade drivers and segmentation logic.)

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What are the main regulatory and labeling drivers for isopropyl alcohol antiseptic products?

Regulatory position in practice: IPA is used as an antiseptic/disinfectant in OTC product contexts and in healthcare manufacturing where compliance depends on finished product labeling, active concentration, directions, and manufacturing controls.

Commercial “regulatory leverage” comes from

• achieving label claims tied to specific organism kill performance (when product category rules allow),
• consistent concentration control (v/v specification stability),
• compatibility validation with wipes, foams, gels, and skin interfaces,
• manufacturing quality systems and traceability for healthcare procurement.

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How does isopropyl alcohol compare with ethanol, chlorhexidine, and quats for antisepsis?

Competitive axis: adoption depends on tolerability, drying time, residue, supply continuity, and performance at realistic skin conditions.

Typical comparative procurement logic

• Ethanol: strong performance and familiar procurement pathways but can face supply and pricing swings.
• Chlorhexidine: strong residual effect for some protocols; formulations and patient tolerance drive use.
• Quats: good for surfaces; healthcare skin antisepsis performance depends on protocol.
• IPA: strong efficacy when correctly concentrated, with widespread availability and simpler formulation paths for wipes and gels.

Featured snippet answer: IPA competes on concentration-performance evidence, usability (dry time, spreadability), and supply continuity, not on novelty.

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Where are the patent and exclusivity barriers for isopropyl alcohol?

Directly: IPA as an active ingredient is established and does not generate an NDA/BLA-style exclusivity perimeter in the way new small-molecule drugs do.

Practically, barriers exist in:

• specific finished-product formulations (gels/wipes with stabilizers, humectants, or skin-conditioning agents),
• manufacturing methods and quality control specifications for healthcare-grade products,
• packaging and delivery systems (wiperized formats, actuator compatibility for sprays).

Featured snippet answer: The IP value sits in formulation and productization rather than in IPA itself.

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What generic entry risks exist for isopropyl alcohol-based products?

Because IPA is commodity-active, “generic entry” typically means:

• new brands using the same concentration and claim language,
• contract manufacturers supplying healthcare product lines,
• wipe and gel formats rebranded for institutional procurement.

Featured snippet answer: The main barriers are regulatory claim substantiation and manufacturing QA, not active-ingredient scarcity.

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What clinical outcome evidence changes procurement for isopropyl alcohol products?

Procurement decisions are moved by:

• trial evidence that supports faster workflow adoption (time-to-dry, reduced smear),
• tolerability data for frequent use,
• compliance improvements and bundle effectiveness,
• demonstrable antimicrobial efficacy under realistic conditions.

Featured snippet answer: Hospital and care-setting procurement usually requires evidence that maps to standardized infection prevention and workflow metrics, not just lab log-reduction.

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Who are the key commercial players likely to supply isopropyl alcohol antiseptic products?

At the active-ingredient level, supply comes from chemical producers; at the product level, supply comes from formulation and contract manufacturing firms that package for healthcare.

Featured snippet answer: The competitive landscape splits into (i) IPA producers feeding (ii) healthcare formulation manufacturers and (iii) institutional brands purchasing finished goods.

(Company identification and market-share tables require market datasets not included in the prompt.)

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Key Takeaways

• Isopropyl alcohol clinical trials concentrate on concentration, contact-time, and delivery-system performance for antisepsis protocols, not on novel IPA drug entities.
• Market growth is anchored to hygiene demand cycles and formulation penetration (wipes, gels, sprays) rather than to molecular innovation.
• The most predictive investment levers are procurement-driven evidence for label claims, manufacturing QA for healthcare-grade products, and feedstock-driven supply continuity that stabilizes margins.
• “Exclusivity” risk is low at the active-ingredient level; barriers are formulation, claims substantiation, and finished-product manufacturing.

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FAQs

1. Are isopropyl alcohol wipes clinically proven for reducing skin bioburden versus ethanol?
2. What concentration of isopropyl alcohol (60% vs 70%) is most commonly used in healthcare antisepsis protocols?
3. How do isopropyl alcohol supply shocks affect pricing for healthcare antiseptic products?
4. Do isopropyl alcohol antiseptic products have an FDA Orange Book listing or patent exclusivity?
5. What stability and compatibility issues affect isopropyl alcohol gels and sprays over shelf life?

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References

No sources were provided in the prompt, and none are cited here.