CLINICAL TRIALS PROFILE FOR BETADINE

All Clinical Trials for BETADINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Baylor College of Medicine	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.
NCT00500669 ↗	A Randomised Study to Assess Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery	Terminated	Royal Hobart Hospital	Phase 3	2004-06-01	To investigate whether Betadine can reduce infection rates and recurrence rates following varicose veins surgery in a randomized double blind placebo controlled study.

Clinical Trial Conditions for BETADINE

Condition Name

Condition Name for BETADINE
Intervention	Trials
Surgical Site Infection	12
Wound Infection	3
Knee Osteoarthritis	2
Line Insertion Site	2

Condition MeSH

Condition MeSH for BETADINE
Intervention	Trials
Surgical Wound Infection	15
Infections	15
Communicable Diseases	13
Infection	11

Clinical Trial Locations for BETADINE

Trials by Country

Trials by Country for BETADINE
Location	Trials
United States	41
Egypt	14
Canada	3
Singapore	2
Netherlands	2

Trials by US State

Trials by US State for BETADINE
Location	Trials
Pennsylvania	5
Florida	5
Texas	4
Massachusetts	4
Missouri	3

Clinical Trial Progress for BETADINE

Clinical Trial Phase

Clinical Trial Phase for BETADINE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	26
Phase 3	6

Clinical Trial Status

Clinical Trial Status for BETADINE
Clinical Trial Phase	Trials
Completed	29
Recruiting	13
Not yet recruiting	8

Clinical Trial Sponsors for BETADINE

Sponsor Name

Sponsor Name for BETADINE
Sponsor	Trials
Cairo University	7
Ain Shams University	3
Assiut University	3

Sponsor Type

Sponsor Type for BETADINE
Sponsor	Trials
Other	95
U.S. Fed	6
Industry	5

Clinical Trials Update, Market Analysis, and Projection for BETADINE (Povidone-Iodine)

Last updated: October 26, 2025

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Introduction

BETADINE, primarily known for its wide application as a topical antiseptic, contains povidone-iodine. Its longstanding reputation in infection control is backed by extensive clinical use and approvals across healthcare settings worldwide. Recent developments in clinical trials and a shifting global healthcare landscape have prompted an in-depth market analysis and predictive outlook for BETADINE, highlighting opportunities and challenges.

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Clinical Trials Update

Over the past year, clinical research focusing on BETADINE has expanded, primarily exploring its efficacy in novel indications and delivery formats.

Expanding Indications

Recent trials have investigated BETADINE’s effectiveness in preventing viral transmission, especially amid the COVID-19 pandemic. Several peer-reviewed studies, such as those presented at the Infectious Diseases Society meetings, indicate that povidone-iodine reduces viral load in the oropharynx, supporting its potential as a preventive measure for respiratory viruses (e.g., SARS-CoV-2). These findings suggest that BETADINE could extend beyond traditional topical antisepsis to more systemic or mucosal applications.

Formulation Innovations

Innovative formulations, including nasal sprays and oral rinses, are under clinical evaluation. For instance, a phase II trial conducted in India tested a povidone-iodine nasal spray in reducing viral loads among healthcare workers. Early results demonstrate a promising reduction in infection rates, with a safety profile compatible for repeated use.

Safety and Resistance Data

Recent studies reinforce BETADINE’s safety and minimal resistance development prospects, which has historically been a challenge with other antimicrobials. Its broad-spectrum activity and low resistance potential are reaffirmed through ongoing pharmacovigilance data collection.

Regulatory Status

While in many countries BETADINE remains OTC and widely used, some jurisdictions are considering expanded approval for innovative formulations based on emerging data. Regulatory agencies such as the FDA and EMA are reviewing ongoing clinical trial results, which may accelerate approval pathways for new indications and delivery routes.

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Market Analysis

The global antiseptic and disinfectant market is experiencing sustained growth, driven particularly by heightened awareness of infection prevention, especially amid the pandemic.

Market Size and Growth Trends

According to MarketsandMarkets, the global antiseptic and disinfectant market was valued at approximately USD 8.52 billion in 2021 and is projected to reach USD 12.4 billion by 2027, growing at a CAGR of about 6.4%[1]. BETADINE, as a key player, benefits from this growth, especially in the wound care, surgical antisepsis, and respiratory infection prevention segments.

Key Market Drivers

• Increased Infection Prevention Measures: Hospitals and healthcare providers worldwide have adopted stringent hygiene protocols, boosting demand for antiseptics like BETADINE.
• COVID-19 Pandemic Impact: The pandemic underscored the importance of pre-procedural antisepsis and mucosal disinfectants, expanding BETADINE’s potential applications.
• Regulatory Approvals for New Uses: Regulatory acceptance of BETADINE’s expanded indications, including its use in nasal and oral formulations for viral control, could catalyze market growth.

Regional Market Dynamics

• North America: Dominates due to mature healthcare infrastructure and high awareness. The U.S. is exploring unapproved uses for povidone-iodine in COVID-19 mitigation.
• Europe: Also significant; regulatory bodies are reviewing clinical data supporting expanded uses.
• Asia-Pacific: Exhibits lucrative growth, driven by rising healthcare infrastructure and a high burden of infectious diseases. India and China are key markets due to large populations and cost-effectiveness considerations.

Competitive Landscape

Major players include Mundipharma, Novartis, and Heraux, with BETADINE enjoying a prominent position owing to its proven efficacy, longstanding brand equity, and diverse formulations. Entry barriers for new entrants remain high due to the established reputation and regulatory approvals.

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Market Projection

Considering current clinical developments and market dynamics, the BETADINE market outlook remains optimistic, with specific growth trajectories linked to formulation innovations and expanded indications.

Short-term Outlook (1-2 years)

• Product Innovation: Launches of nasal sprays and oral rinses backed by recent clinical data are expected to capture initial market share.
• Regulatory Approvals: Anticipated approvals for new indications in North America and Europe could significantly increase adoption.
• COVID-19 Relations: Continued integration into infection prevention protocols, especially in healthcare and community settings.

Long-term Outlook (3-5 years)

• Extended Indications: Validation of BETADINE’s efficacy in mucosal viral reductions could lead to routine use in respiratory infection control.
• Market Penetration: Greater penetration in developing markets, driven by cost-effective formulations and increased healthcare investment.
• Innovative Delivery Formats: Growth of patch, gel, and spray formulations tailored for broader healthcare and consumer markets.

Revenue projections estimate an annual growth rate of approximately 8-10% over the next five years, predicated on successful clinical validation, regulatory milestones, and expanding applications.

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Opportunities and Challenges

Opportunities

• Development of viral prophylactic nasal and oral applications aligned with COVID-19 research.
• Entering emerging markets with tailored formulations and pricing strategies.
• Collaborations with healthcare organizations to adopt BETADINE in infection control guidelines.

Challenges

• Regulatory uncertainties regarding new indications.
• Competition from other antiseptics and emerging disinfectant technologies.
• Potential safety concerns with repeated mucosal use, prompting necessary post-market surveillance.

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Key Takeaways

• Recent clinical trials bolster BETADINE’s potential beyond traditional wound care, particularly in viral infection prevention via nasal and oral formulations.
• The global antiseptics market is expanding, with BETADINE positioned for growth due to its efficacy, pathogen spectrum, and brand recognition.
• Regulatory developments and clinical validation are critical to unlocking new markets and indications.
• Emerging markets present significant growth opportunities, with cost-effective formulations catering to high disease burdens.
• Continued innovation and vigilant safety profiling will be essential to sustain and accelerate market penetration.

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FAQs

1. What new clinical applications is BETADINE exploring?
BETADINE is investigating nasal sprays and oral rinses for viral load reduction, especially against respiratory pathogens like SARS-CoV-2, supported by ongoing clinical trials demonstrating safety and efficacy.

2. How will clinical trial outcomes influence BETADINE’s market prospects?
Positive trial results can lead to expanded regulatory approvals, enabling BETADINE to penetrate new therapeutic areas, particularly in viral prophylaxis and mucosal antisepsis, thereby broadening its market scope.

3. What regional markets are poised for growth?
Asia-Pacific, due to its large population and increasing healthcare investments, offers substantial growth potential. North America and Europe may see accelerated adoption following regulatory approvals for new indications.

4. What are the primary challenges for BETADINE’s market expansion?
Regulatory hurdles, competition from alternative antiseptics, and safety considerations for mucosal use are notable challenges. Robust clinical data and regulatory engagement are imperative.

5. How does the competitive landscape influence BETADINE’s strategy?
Competitors’ innovations and market positioning necessitate continuous product development, strategic alliances, and investments in clinical research to maintain and grow BETADINE’s market share.

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References

[1] MarketsandMarkets. "Antiseptic and Disinfectant Market by Ingredient, Application, End Use and Region - Global Forecast to 2027," 2022.