CLINICAL TRIALS PROFILE FOR POVIDONE IODINE

505(b)(2) Clinical Trials for Povidone Iodine

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	NCT01560962 ↗	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis	Terminated	Southern California Institute for Research and Education	N/A	2012-01-01	Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

All Clinical Trials for Povidone Iodine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	Santen Gmbh	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	The European Society of Cataract and Refractive Surgeons(ESCRS)	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	City, University of London	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.

Clinical Trial Conditions for Povidone Iodine

Condition Name

Condition Name for Povidone Iodine
Intervention	Trials
Surgical Site Infection	18
COVID-19	11
Endophthalmitis	7

Condition MeSH

Condition MeSH for Povidone Iodine
Intervention	Trials
Infections	37
Infection	30
Surgical Wound Infection	28

Clinical Trial Locations for Povidone Iodine

Trials by Country

Trials by Country for Povidone Iodine
Location	Trials
United States	132
Egypt	25
France	12
Canada	10
Spain	8

Trials by US State

Trials by US State for Povidone Iodine
Location	Trials
Illinois	10
Texas	9
Pennsylvania	8
New York	8
Missouri	8

Clinical Trial Progress for Povidone Iodine

Clinical Trial Phase

Clinical Trial Phase for Povidone Iodine
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for Povidone Iodine
Clinical Trial Phase	Trials
Completed	92
Recruiting	40
Unknown status	28

Clinical Trial Sponsors for Povidone Iodine

Sponsor Name

Sponsor Name for Povidone Iodine
Sponsor	Trials
Assiut University	8
Ain Shams University	7
Cairo University	6

Sponsor Type

Sponsor Type for Povidone Iodine
Sponsor	Trials
Other	288
Industry	25
U.S. Fed	9

Clinical Trials Update, Market Analysis, and Projection for Povidone Iodine

Last updated: November 7, 2025

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Introduction

Povidone iodine, a broad-spectrum antiseptic, remains a staple in infection control across healthcare settings. Its potent antimicrobial activity and stability have cemented its role in surgical prep, wound management, and disinfection. As global health challenges evolve, particularly in the context of rising antimicrobial resistance and pandemic preparedness, the continued development and market trajectory of povidone iodine warrant detailed analysis. This article synthesizes current clinical trial data, market dynamics, and future projections for povidone iodine, offering strategic insights for stakeholders.

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Clinical Trials Update

Recent and Ongoing Clinical Investigations

Recent clinical trials underscore the expanding application spectrum of povidone iodine. Notably, a pivotal study (NCT04568009) evaluated povidone iodine nasal antisepsis in reducing SARS-CoV-2 viral load among healthcare workers. The randomized, controlled trial demonstrated significant reductions in viral presence, supporting its utility as a pre-procedural prophylactic measure against COVID-19 transmission.

Additionally, a phase III trial (NCT03891093) assessed povidone iodine mouthwash efficacy in reducing oral microbial load, including SARS-CoV-2, in elective dental patients. Results indicated a notable decline in viral and bacterial counts, suggesting an expanded role in dental and oral health practices.

Other ongoing trials focus on povidone iodine's role in surgical site infection (SSI) prevention, wound healing, and as an adjunctive therapy for infectious diseases. These trials have collectively reinforced povidone iodine's safety profile and antimicrobial efficacy. The focus on novel delivery forms, such as nasal sprays and mouthwashes, enhances its applicability in infection control.

Regulatory and Safety Landscape

Regulatory bodies like the U.S. FDA and EMA recognize povidone iodine's established safety profile, though ongoing trials aim to evaluate optimal dosing regimens, minimize adverse effects, and expand indications. Recent updates include approval of povidone iodine-based formulations for nasal application in certain jurisdictions, emphasizing regulatory confidence in its evolving uses.

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Market Analysis

Current Market Size and Segmentation

As of 2023, the global povidone iodine market was valued at approximately USD 250 million, with a compound annual growth rate (CAGR) of around 4.8% over the past five years [1]. Its primary segments include healthcare facility disinfection, wound care, surgical prep, and emerging prophylactic applications, notably in viral mitigation.

Regionally, North America dominates due to extensive healthcare infrastructure and high awareness, accounting for nearly 45% of market share. Europe follows, benefiting from stringent infection control standards. The Asia-Pacific region exhibits rapid growth potential, driven by rising healthcare expenditure, increasing surgical procedures, and pandemic-related demand.

Drivers of Market Growth

Several factors propel market expansion:

• Expanded Indications: The recent clinical evidence supporting povidone iodine's antiviral applications, especially against SARS-CoV-2, opens avenues for its broader use in infection prevention protocols.

• COVID-19 Pandemic: Heightened focus on infection control measures has accelerated demand, especially for antiseptic nasal and oral formulations.

• Wound Care and Surgical Applications: The ongoing need for effective preoperative skin antisepsis and wound management sustains steady market demand.

• Regulatory Approvals and Product Innovation: Introduction of novel formulations, such as rapid-acting nasal sprays, enhance product portfolio and market reach.

• Cost-Effectiveness: Its low cost compared to newer antiseptics positions povidone iodine as a preferred choice in resource-limited settings.

Market Challenges

Despite positive outlooks, several constraints persist:

• Allergic Reactions: Rare allergic responses necessitate cautious application, limiting universal adoption.

• Environmental Concerns: Disposal and environmental impact of iodine-containing compounds may invite regulatory scrutiny.

• Competition: Alternative antiseptics, like chlorhexidine, and emerging disinfectants, challenge its market share.

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Future Market Projections

Forecast for 2025 and 2030

Based on current trends and ongoing clinical development, the povidone iodine market is projected to reach approximately USD 350–400 million by 2025, reflecting a CAGR of around 5%. The growth trajectory is expected to sustain into 2030, with estimates exceeding USD 500 million, driven by several emerging factors:

• Enhanced Antiviral Role: With evidence mounting for povidone iodine's efficacy against coronaviruses, its inclusion in routine preoperative and pre-procedural settings is likely to increase.

• Expansion into New Indications: Clinical trials targeting fungal infections, conjunctivitis, and oral antisepsis may introduce new revenue streams.

• Product Innovation: Development of patient-friendly formulations (e.g., sprays, gels, rapid-dissolving forms) bolsters adoption.

• Increased Healthcare Investment: Rising healthcare budgets globally, particularly in emerging economies, will facilitate market penetration.

Impact of Regulatory and Political Factors

Regulatory confirmations of povidone iodine's safety and efficacy, coupled with inclusion in infection control guidelines, will further boost market adoption. However, geopolitical issues, supply chain stability, and environmental regulations pose potential risks.

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Strategic Insights for Stakeholders

• Invest in R&D: Focus on novel delivery systems and expanding antiviral indications, leveraging ongoing clinical trial results.

• Navigate Regulatory Pathways: Engage with authorities proactively to secure approvals for new indications and formulations.

• Market Expansion: Target emerging markets through cost-effective, easy-to-apply formulations, aligning with global health priorities.

• Environmental and Safety Considerations: Address ecological concerns by developing more sustainable iodine formulations to sustain long-term market viability.

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Key Takeaways

• Povidone iodine continues to demonstrate robust antimicrobial and antiviral efficacy, supported by recent clinical trials highlighting its utility against SARS-CoV-2.

• The global market is poised for steady growth, driven by expanded indications, pandemic-related demand, and innovation in formulation.

• Regulatory acceptance and clinical validation are critical to unlocking new application areas and market segments.

• Environmental and safety considerations will shape product development and regulatory strategies moving forward.

• Stakeholders who invest in formulation innovation, regulatory engagement, and market expansion are positioned to capitalize on the drug’s evolving role in infectious disease management.

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FAQs

1. What are the key clinical applications of povidone iodine today?
Povidone iodine is primarily used for surgical skin antisepsis, wound disinfecting, mucous membrane decontamination, and as an oral or nasal antiseptic, especially in infection control protocols.

2. How is povidone iodine being studied for COVID-19?
Clinical trials have investigated its use as a nasal spray and oral rinse to reduce viral load, demonstrating promising results in decreasing SARS-CoV-2 presence, thus supporting its prophylactic role.

3. What are the main factors influencing the market growth of povidone iodine?
Drivers include expanding antiviral indications, pandemic-driven demand, product innovations, and cost-effectiveness. Challenges include safety concerns and competition from alternative antiseptics.

4. Are there emerging formulations of povidone iodine?
Yes, recent developments include nasal spray formulations, mouthwashes, gels, and rapid-dissolving forms aimed at improving patient compliance and extending uses.

5. What regulatory outlook exists for povidone iodine’s new indications?
Regulatory agencies are increasingly receptive, with some formulations already approved for specific uses. As clinical data accumulates, further approvals are anticipated, especially for antiviral applications.

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References

[1] MarketResearch.com. “Global Povidone Iodine Market Analysis & Forecast 2022-2027.”
[2] ClinicalTrials.gov. “Ongoing Studies on Povidone Iodine in COVID-19 and Other Infectious Diseases.”
[3] Grand View Research. “Antiseptic Market Size, Share & Trends Analysis Report, 2022-2030.”