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.
NCT00223002 ↗	Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient	Completed	University of Saskatchewan	N/A	2004-11-01	Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill. This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.

Clinical Trial Conditions for povidone-iodine

Condition Name

Condition Name for povidone-iodine
Intervention	Trials
Surgical Site Infection	18
COVID-19	11
Endophthalmitis	7
Covid19	6

Condition MeSH

Condition MeSH for povidone-iodine
Intervention	Trials
Infections	37
Infection	30
Surgical Wound Infection	28
Communicable Diseases	24

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
Turkey	8

Trials by US State

Trials by US State for povidone-iodine
Location	Trials
Illinois	10
Texas	9
New York	8
Missouri	8
Florida	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	4

Clinical Trial Status

Clinical Trial Status for povidone-iodine
Clinical Trial Phase	Trials
Completed	92
Recruiting	39
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: October 28, 2025

Overview of Povidone-Iodine

Povidone-iodine, also known as polyvinylpyrrolidone-iodine, is an antimicrobial agent widely used as a disinfectant in medical, veterinary, and personal care settings. Its efficacy against bacteria, fungi, viruses, and protozoa has cemented its role in infection control, particularly in surgical skin preparation and wound care. Despite decades of stable use, recent developments have rekindled interest in Povidone-iodine’s potential beyond traditional applications, prompted by ongoing clinical investigation and the global emphasis on infection prevention, especially in the context of COVID-19.

Clinical Trials Update

Recent Clinical Trial Landscape

The current clinical landscape indicates an active pursuit of Povidone-iodine’s expanded applications, spanning antiviral, antiseptic, and potentially therapeutic uses. Major clinical trials registered in global databases such as ClinicalTrials.gov provide a window into ongoing research efforts.

• Antiviral Efficacy in Respiratory Routes: Several trials are evaluating Povidone-iodine’s efficacy in reducing viral load in oropharyngeal and nasal cavities. For example, Nasal and Oral Disinfection with Povidone-Iodine trails aim to examine its role in reducing SARS-CoV-2 viral transmission. Preliminary results suggest significant viral load reduction, aligning with in vitro findings [1].

• Preoperative and Postoperative Use: Trials continue to assess Povidone-iodine’s superiority in reducing surgical site infections (SSIs). A notable recent study from Europe demonstrated a decline in SSIs when Povidone-iodine was used as a preoperative antiseptic in elective surgeries, reaffirming its established role.

• Therapeutic Investigations: Emerging studies explore topical Povidone-iodine applications in wound healing and its potential adjunct role in managing mucosal infections, underscoring renewed investigation into its therapeutic prospects beyond disinfection.

Regulatory Developments

The U.S. Food and Drug Administration (FDA) continues to recognize Povidone-iodine as a category I over-the-counter (OTC) antiseptic. However, some recent regulatory statements emphasize the need for updated safety data related to prolonged usage and specific formulations, prompting ongoing studies and reviews [2].

Research Gaps and Future Directions

While extensive data support Povidone-iodine’s antimicrobial effectiveness, gaps remain regarding optimal concentrations for specific indications, long-term safety in repeated applications, and potential systemic absorption risks. The advent of novel formulations—such as wipes, sprays, and gels—aims to enhance delivery and patient compliance, with clinical trials largely focusing on these innovations.

Market Analysis

Current Market Size and Segmentation

The global Povidone-iodine market was valued at approximately USD 300 million in 2022 and is projected to reach USD 430 million by 2030, growing at a CAGR of roughly 4.8%. The factors fueling this growth include increasing infection control measures, rising healthcare expenditures, and expanding use in emerging markets.

Market segmentation reveals:

• Application: Surgical antiseptics account for 45% of demand, followed by wound care (25%), oral and nasal disinfectants (15%), and other uses such as veterinary antisepsis (10%).

• Formulation Type: Liquid Povidone-iodine dominates, but gels, wipes, and sprays are gaining traction due to ease of application.

• Regional Dynamics: North America and Europe currently lead, driven by advanced healthcare infrastructure and regulatory support. However, Asia-Pacific is emerging rapidly due to expanding healthcare access and increased awareness of infection prevention.

Competitive Landscape

Major pharmaceutical companies dominate the field, including:

• HOSPECO and Astellas Pharma, which supply large volumes for surgical and hospital use.
• Reckitt Benckiser (brand: Betadine), which maintains a dominant market position owing to its extensive retail and institutional network.

Innovation efforts focus on formulations that reduce staining, improve patient comfort, and extend shelf life. Mergers, acquisitions, and strategic alliances are also shaping the competitive landscape.

Market Drivers

• Rising Infection Burden: Global focus on infection control, especially amid the COVID-19 pandemic, is boosting Povidone-iodine demand.
• Expanding Use Cases: Its effectiveness against emerging viral pathogens and potential use in hospital sterilization protocols increase applicability.
• Regulatory Endorsement: Classic safety profile combined with regulatory support sustains market confidence.

Market Challenges

• Safety Concerns: Risks of iodine absorption, allergic reactions, and interference with thyroid function restrict certain patient populations.
• Antimicrobial Resistance: Although Povidone-iodine exhibits broad-spectrum activity, emerging concerns about microbial resistance necessitate ongoing surveillance.

Projected Market Outlook

The demand for Povidone-iodine is expected to grow at a steady rate over the next decade. The compounded influence of infectious disease outbreaks, infection prevention norms, and technological innovation will continue to drive expansion, especially into new formulations and applications.

Market Projection and Trends

• 2023–2027: Moderate growth driven by sustained hospital and clinical use, as well as emerging antiviral applications.
• 2028–2030: Accelerated expansion anticipated owing to increased adoption of Povidone-iodine in ambulatory and outpatient settings, driven by innovations in delivery systems.

Emerging markets such as India and China are expected to constitute a significant portion of future growth, supported by healthcare infrastructure development and government initiatives in infection control.

Conclusion

Povidone-iodine remains a cornerstone antiseptic with a resilient market largely due to its proven antimicrobial efficacy, safety profile, and extensive clinical use. Its evolving clinical trial landscape suggests potential expanded indications, especially concerning viral infections. Market growth will be supported by ongoing innovation, increasing healthcare spending, and heightened emphasis on infection prevention measures. Stakeholders should monitor regulatory developments, safety concerns, and technological advancements to capitalize on this ongoing clinical and commercial evolution.

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Key Takeaways

• Clinical research indicates promising antiviral applications, with ongoing trials assessing Povidone-iodine’s role in COVID-19 mitigation.
• Market growth is steady, with projections reaching USD 430 million by 2030, fueled by expanding use cases and regional market development.
• Innovation in formulations—such as gels and wipes—will enhance user compliance, supporting market expansion.
• Regulatory and safety considerations remain vital, especially concerning systemic absorption and allergic reactions in sensitive patient groups.
• Emerging markets are poised to contribute significantly to future demand growth, driven by healthcare infrastructure advancements and infection control priorities.

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FAQs

1. What are the latest clinical advancements involving Povidone-iodine?
Recent trials focus on its antiviral properties, especially for reducing SARS-CoV-2 transmission, and exploring its therapeutic role in wound healing and mucosal infections.

2. How is the market for Povidone-iodine evolving globally?
The market is expanding steadily, particularly in Asia-Pacific, driven by increased healthcare spending and infection control measures, with new formulations enhancing applications.

3. Are there safety concerns associated with prolonged Povidone-iodine use?
Yes, concerns include iodine absorption affecting thyroid function and allergic reactions; ongoing studies seek to clarify safety parameters for extended or repeated applications.

4. What future applications are being researched for Povidone-iodine?
Research is exploring its use as a preventive measure against respiratory viruses, in wound management, and possibly as an adjunct in mucosal therapy.

5. How will regulatory guidance impact the Povidone-iodine market?
Regulatory agencies emphasizing safety and efficacy data will shape formulation approvals and usage guidelines, influencing market accessibility and adoption.