Last Updated: May 12, 2026

CLINICAL TRIALS PROFILE FOR POVIDONE-IODINE


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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.
OTC NCT07356271 ↗ Effects of Mouthwashes on the Oral Microbiome and Systemic Health NOT_YET_RECRUITING University of Plymouth EARLY_PHASE1 2026-02-01 OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00231153 ↗ Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters Completed Cadence Pharmaceuticals Phase 3 2005-08-01 The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
NCT00231153 ↗ Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters Completed Mallinckrodt Phase 3 2005-08-01 The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

Trials by Country for povidone-iodine
Location Trials
United States 132
Egypt 28
France 12
Canada 10
Spain 8
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Trials by US State

Trials by US State for povidone-iodine
Location Trials
Illinois 10
Texas 9
Pennsylvania 8
New York 8
Missouri 8
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Clinical Trial Progress for povidone-iodine

Clinical Trial Phase

Clinical Trial Phase for povidone-iodine
Clinical Trial Phase Trials
PHASE4 6
PHASE3 1
PHASE2 5
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Clinical Trial Status

Clinical Trial Status for povidone-iodine
Clinical Trial Phase Trials
Completed 94
Recruiting 40
Unknown status 28
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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
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Sponsor Type

Sponsor Type for povidone-iodine
Sponsor Trials
Other 292
Industry 25
U.S. Fed 9
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Povidone-iodine Market Analysis and Financial Projection

Last updated: April 27, 2026

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

What is the current clinical-trial landscape for povidone-iodine?

Povidone-iodine is a long-established broad-spectrum antiseptic. Most evidence sits in topical/wound and infection-prevention settings using small-to-moderate clinical studies, registries, and pragmatic trials, rather than single large, late-stage pivotal programs typical of modern, new-molecular-entity development.

Across public registries, the active clinical-trial footprint for povidone-iodine tends to concentrate in three cohorts:

  • Surgical site infection (SSI) prevention (preoperative skin prep and peri-procedural antisepsis).
  • Wound care and debridement settings (including burn wounds, ulcer management, and infection control in dressings).
  • Acute mucosal or procedural use cases (oral, pharyngeal, or catheter-associated infection prevention workflows), where povidone-iodine is compared to other antiseptics or alternative protocols.

Observed trial design pattern

  • Comparators often include chlorhexidine, alcohol-based antiseptics, or other iodophor formulations.
  • Endpoints typically track infection incidence, microbial burden, time-to-healing, or colonization clearance rather than disease-modifying outcomes.
  • Regulatory strategy is frequently label-extension style, protocol-based, or formulation change (concentration, vehicle, or delivery format), with clinical work to support safety and performance in real-world workflows.

Bottom line for R&D planning The clinical development posture for povidone-iodine is best characterized as product-lifecycle optimization and protocol validation, not pipeline innovation. Companies generally compete on formulation, tolerability, usability, and line-of-care fit more than on new biological mechanisms.

Where does povidone-iodine compete in the market?

Povidone-iodine is sold in multiple formats across consumer and professional channels. Demand is anchored by routine use in:

  • Preoperative skin antisepsis and surgical prep.
  • Wound care and dressing-related antisepsis.
  • Infection control in minor injuries and first-aid applications.
  • Mucosal antisepsis where indicated and labeled.

Competitive set

  • Primary antiseptic substitutes: chlorhexidine (skin and mucosal), alcohol-based antiseptics, benzalkonium chloride, hydrogen peroxide, and silver-based wound products.
  • Operational substitutes: different clinical protocols (duration, application method, concentration), sterilization workflows, and barrier dressings.
  • Same-mechanism substitutes: other iodophor formulations or similar antiseptic blends.

Market behavior characteristics

  • Procurement-driven demand in hospitals and surgery centers supports recurring volumes.
  • SKU-level competition is high: iodophor concentration, foam/scrub solutions, swab formats, and wound dressings carry differentiation.
  • Pricing pressure increases during tender cycles, especially where supply is commoditized.

How big is the povidone-iodine market and what is the growth outlook?

Public market coverage for povidone-iodine often reports the total antiseptics category and the iodophor segment using forecasting models tied to wound care, SSI prevention spending, and hospital throughput. Reported growth trajectories are generally low-to-mid single digits in mature markets, with higher incremental growth in markets where healthcare access and surgical volumes expand faster.

Given the long history and commodity-like positioning, projections depend heavily on:

  • Healthcare facility penetration (adoption of standardized SSI-prevention protocols).
  • Surgical volumes and procedure mix.
  • Wound care utilization (diabetes and chronic wound prevalence trends).
  • Switching elasticity between antiseptics at tender time (chlorhexidine and alcohol-based products frequently substitute where clinically acceptable).
  • Regulatory and safety labeling trends (iodine exposure considerations, thyroid-related precautions in specific populations).

Market projection framework used for investment and planning

  1. Base demand: SSI prevention, wound care, routine antisepsis.
  2. Share and mix: shift from bulk liquids to swabs, dressings, and ready-to-use formats.
  3. Geographic scaling: emerging market growth via increased surgeries and improved facility coverage.
  4. Competitive substitution: chlorhexidine and alcohol-based antiseptics can cap share growth.
  5. Price and contracting: tender cycles drive margin volatility.

What product and formulation levers drive commercial differentiation?

Commercial differentiation for povidone-iodine mostly comes from:

  • Delivery format: scrub solutions, paint-on prep, swabs, foams, and impregnated dressings.
  • Concentration and contact time: balancing rapid antimicrobial action with skin tolerability.
  • Skin and mucosal compatibility: minimizing irritation while maintaining antiseptic performance.
  • Stability and shelf life: reducing degradation and maintaining potency under storage constraints.
  • Operational usability: non-drip applications, pre-measured swab formats, and workflow fit for operating rooms and dressing changes.

From a portfolio perspective, these levers align with label support and protocol adoption rather than mechanism-based differentiation.


Clinical Trial Signals Worth Monitoring

What trial categories are most likely to move the needle commercially?

The trials most likely to influence adoption and reimbursement decisions are those that:

  • Standardize preoperative skin preparation workflows, especially comparing povidone-iodine against chlorhexidine/alcohol-based strategies in real clinical settings.
  • Target high-risk wound populations (burns, chronic ulcers, post-debridement wounds) with endpoints tied to infection rates and healing velocity.
  • Support new presentation formats (swabs, foams, dressing systems) using practical endpoints: time to apply, patient tolerance, and infection control performance.

What endpoints matter to stakeholders?

Across antiseptics, endpoints that align with clinical and procurement decision-making include:

  • SSI incidence after surgery.
  • Microbial reduction/colonization clearance (time-bound).
  • Time-to-healing and complication rates for wounds.
  • Treatment adherence and usability (where pragmatic studies collect workflow metrics).
  • Safety in special populations (tolerability, irritation, and iodine exposure considerations where relevant).

Market Analysis by Use Case

How does demand split across major applications?

While public segment breakdown varies by source, procurement patterns usually allocate demand across:

  • Preoperative skin antisepsis: large volume in hospitals and ambulatory surgery centers.
  • Wound care: meaningful demand driven by chronic conditions and dressing usage.
  • Minor injuries and consumer use: steady volume but more price-sensitive.
  • Mucosal antisepsis and procedural indications: smaller but label-driven demand.

Implication for forecasting

  • If you model on surgical and wound procedure growth, povidone-iodine behaves like an antisepsis utilization product with recurring demand.
  • If you model on antiseptic tender cycles, it behaves like a substitutable commoditized antiseptic, with growth constrained by clinical interchangeability.

What is the main risk to market share?

The main commercial risk is substitution by competing antiseptics, particularly chlorhexidine and alcohol-based products in skin antisepsis workflows, depending on local guidelines and clinician preference.


Pricing and Margin Dynamics

What drives revenue and margin outcomes?

For povidone-iodine, margin depends on:

  • Format mix (ready-to-use swabs and dressings generally price higher than bulk liquids).
  • Channel mix (hospital tends to be contract-driven; consumer retail is promotional and competitive).
  • Supply and input cost (iodine and formulation inputs; also manufacturing efficiency).
  • Regulatory burden for formulation and label changes.
  • Tender competitiveness (shortlisted suppliers bid aggressively).

Forward Projection (Scenario-Based)

What does a practical 3- to 5-year projection look like?

Because povidone-iodine is mature and substitution-heavy, projections should be modeled in scenarios rather than a single-line growth rate.

Scenario structure

  • Base case: low-to-mid single digit growth supported by procedure volumes and protocol standardization; modest share stability.
  • Upside case: higher share capture from format upgrades (swabs/dressings), faster adoption in high-throughput hospital systems, and successful label expansions.
  • Downside case: increased tender substitution by chlorhexidine/alcohol-based systems and persistent pricing pressure.

Key drivers that typically determine which scenario plays out

  • Guideline adherence and procurement specs at national or large-system level.
  • Performance data supporting infection reduction in specific high-risk contexts.
  • Usability and tolerability that influence clinician uptake.
  • Supply continuity and contract pricing during tender cycles.

Key Takeaways

  • Povidone-iodine clinical activity largely supports protocol validation, format changes, and label extensions rather than new mechanism development.
  • Market growth is typically mature, procurement-led, and substitution-sensitive, with chlorhexidine and alcohol-based antiseptics the closest competitive caps in skin prep.
  • Commercial upside usually comes from ready-to-use formats and dressing systems, which shift revenue from commodity bulk into higher-value SKU categories.
  • Forward projections should use scenario modeling driven by surgical and wound procedure growth, tender outcomes, and format mix.

FAQs

1) Is povidone-iodine still being tested in clinical trials?

Yes, with studies concentrated in SSI prevention, wound care, and procedural antisepsis workflows, often comparing against other antiseptic standards and focusing on infection-related endpoints and practical performance.

2) What is the competitive threat to povidone-iodine in hospitals?

Chlorhexidine and alcohol-based antiseptics, plus alternative wound antiseptics and dressing strategies, depending on local guidelines and tender specifications.

3) What parts of the portfolio tend to outperform commodity bulk liquids?

Ready-to-use formats such as swabs, foams, and impregnated dressings typically command better pricing and stronger differentiation.

4) What endpoints are most persuasive for adoption?

SSI incidence, microbial burden/colonization clearance, time-to-healing for wounds, and safety/tolerability in the intended use populations.

5) How should an investor model growth for povidone-iodine?

Use procedure-volume demand (surgery and wound utilization) as the base, then apply scenarios for tender substitution risk, price pressure, and format mix changes.


References (APA)

[1] World Health Organization. (2016). Global guidelines for the prevention of surgical site infection. WHO. https://www.who.int/publications/i/item/9789241549882
[2] European Medicines Agency. (n.d.). Public documents and information on povidone-iodine containing products. EMA. https://www.ema.europa.eu
[3] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov (search results for povidone-iodine). https://clinicaltrials.gov
[4] Centers for Disease Control and Prevention. (2017). Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. CDC. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
[5] National Institute for Health and Care Excellence. (n.d.). Medicines information and wound infection guidance involving antiseptics. NICE. https://www.nice.org.uk

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