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.
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.

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.

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	28
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	6
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for Povidone Iodine
Clinical Trial Phase	Trials
Completed	94
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	292
Industry	25
U.S. Fed	9

Last updated: May 11, 2026

Povidone Iodine: clinical trials update, market analysis, and revenue projection

What clinical trials are ongoing for povidone-iodine in 2024–2026?

Povidone iodine is broadly used as an antiseptic in wound care, preoperative skin preparation, and mucosal applications. The molecule’s clinical evidence base is large, but many current studies are low-to-moderate complexity (formulation comparisons, setting of use, and practice optimization) rather than new active-ingredient development. Public trial activity is concentrated in wound/skin infection prevention, perioperative antisepsis, and product-format performance.

What trial endpoints are most common for povidone-iodine?

• Incidence of surgical site infection (SSI) or catheter-associated infection in perioperative settings
• Bacterial load reduction on skin or mucosa (quantitative cultures)
• Healing metrics in wound care (time to granulation, epithelialization, infection rates)
• Product performance endpoints: residual activity, staining/irritation, patient tolerance, and ease-of-use

Which study types appear most often?

• Randomized comparative trials vs chlorhexidine, alcohol-based antiseptics, or alternative povidone iodine strengths
• Non-inferiority or equivalence trials of concentration and vehicle (aqueous vs gel vs solution, different povidone iodine complexes)
• In-use effectiveness studies in burns/wounds, where povidone iodine products are used as part of standard care pathways

Clinical trials status summary

• Active and recruiting studies exist, but the development pipeline is mostly incremental on formulation and delivery rather than new indications with registration-enabling outcomes.
• Late-stage (Phase 3 registrational) activity is less prominent than for novel antiseptics, given povidone iodine’s established regulatory standing and widespread off-the-shelf availability.

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

The povidone iodine market is driven by surgical antisepsis and wound care demand, sustained healthcare utilization, and the breadth of product formats (solutions, swabs, gels, ointments, throat/mouth preparations). Market sizing varies by analyst methodology because products are sold under multiple brands and often within hospital procurement categories.

Market dynamics

• Baseline demand is stable because povidone iodine is embedded in hospital protocols for skin disinfection and in outpatient wound care
• Growth comes from higher procedure volumes and expanded chronic wound management
• Competitive pressure typically centers on chlorhexidine and newer antiseptic technologies, with povidone iodine maintaining share through availability, cost position, and tolerability

Key market drivers

• Increased surgical volumes and infection-prevention programs
• Aging populations and higher incidence of chronic wounds and dermatologic conditions
• Continuing use in burns and superficial wound management in many healthcare systems
• Cold-chain and stability advantages of many povidone iodine formats relative to some alternative antiseptic preparations

Key headwinds

• Product-level price competition in commoditized antiseptic segments
• Safety and tolerability scrutiny (iodine-related concerns in specific patient populations; irritation)
• Substitution to chlorhexidine in certain protocols and geographies

What products and indications drive revenue for povidone-iodine?

Revenue is typically split across major use cases, with format and geography as the main segmentation axes.

Indications/use cases

• Preoperative skin preparation (solutions, swabs, applicators)
• Wound care and burn antisepsis (gels, creams/ointments, aqueous forms)
• Mucosal antisepsis (oral/throat preparations, depending on local approvals)
• Dermatologic antisepsis (pre/post procedure skin cleansing)
• Institutional and emergency care utilization

Format segmentation

• Single-use swabs and applicators (hospital procurement volumes)
• Bottled solutions (outpatient and home-use channels)
• Gels/ointments/creams (wound dressing workflows)
• Specialty formats (for specific mucosal routes where approved)

When does povidone iodine lose exclusivity or face generic entry risk?

For povidone iodine, exclusivity risk is structurally different from branded small-molecule drugs and biologics because the active ingredient is old and widely genericized. The practical question is not loss of active-ingredient exclusivity but whether specific brand/product patents, formulation patents, or method-of-use claims remain enforceable in a given jurisdiction.

Practical exclusivity view

• Many povidone iodine products are not protected by meaningful composition-of-matter exclusivity.
• IP protection, where present, tends to be narrow and format-specific (vehicle, concentration range, stabilizers, delivery device claims, or manufacturing methods).
• Generic substitution risk is typically high at the active-ingredient level, with barriers driven by regulatory listing and packaging/branding, not pharmacologic innovation.

Litigation and settlement dynamics

• Where patents exist, disputes can arise around formulation or method-of-manufacture claims, but high-frequency Paragraph IV-style litigation is not a defining feature for povidone iodine segments compared with prescription anti-infectives.

What patent estate protects povidone-iodine products, and how strong is it?

Povidone iodine is generally considered a legacy antiseptic with broad prior art coverage. Strong patent estates are more likely around specific branded formulations, delivery systems, and manufacturing processes than around the base chemistry.

Most likely patent categories

• Formulation patents for gels/creams/ointments and stability of the povidone iodine complex in specific vehicles
• Packaging and delivery device claims (applicators, swabs, controlled-release concepts if used)
• Manufacturing method claims (process controls, sterilization approach, moisture/iodine retention)
• Method-of-use claims (protocolized use patterns), though these can be easier to design around

Strength profile

• Typically narrow in scope; enforceability depends on claim drafting and factual infringement evidence
• Design-around is often feasible at the formulation level (different vehicles, concentrations, or stabilizers), shifting value toward regulatory brand and supply-chain execution

What is the FDA regulatory status of povidone iodine products?

In the US, povidone-iodine antiseptics are widely marketed as nonprescription or as regulated over-the-counter antiseptic products under applicable FDA frameworks. Regulatory categorization depends on route, dosage form, and labeling claims.

Common regulatory themes

• OTC antiseptic monographs or product-specific approvals for certain claims, depending on the exact product and claim structure
• Hospital formulations and wound-care products typically follow established regulatory pathways with labeling-specific constraints
• Many brands are listed under standard FDA product listing systems and supported by established manufacturing and labeling dossiers

How does povidone iodine compare with chlorhexidine for perioperative antisepsis?

Chlorhexidine-based antiseptics compete directly in preoperative skin preparation in many healthcare systems. Market share tends to rotate based on protocol preferences, safety considerations, and institutional purchasing.

Comparison factors that affect adoption

• Residual activity and spectrum differences
• Cost per dose and procurement contracts
• Skin tolerance profiles (including irritation and sensitivity)
• Local guideline alignment and surgeon/anesthesiology protocol standards

Commercial implication

Even where chlorhexidine is preferred, povidone iodine remains a fallback option due to broad tolerability, established familiarity, and availability in multiple formats.

What generic entry risks exist for povidone iodine brands?

Generic entry risk is usually driven by product-formulation IP, not active-ingredient exclusivity.

Primary drivers of entry

• Ability to replicate concentration and performance characteristics within labeling constraints
• Manufacturing process control to achieve acceptable stability and iodine release profile
• Regulatory pathway feasibility for specific dosage forms and claims
• Competitive pricing pressure once multiple low-cost equivalents are established

High-level risk assessment

• For many markets, incremental generic substitution is routine for solution and swab formats
• Greater resistance to entry can occur for specialty formats requiring device integration or unique formulation stability claims

Market projection for povidone iodine (2026–2031)

A reliable projection for povidone iodine must be anchored to market sizing, growth rates, and route-to-market expansion in each geography. Public, analyst-grade market sizing varies widely, and exact projections depend on baseline numbers that are not specified here. What can be quantified without those inputs is the directionality of the demand drivers and commercial leverage points.

Scenario-based outlook

• Base case: steady growth tied to surgical volumes, chronic wound care spend, and procurement stability of antiseptic protocols
• Downside: continued substitution to chlorhexidine in some settings and pricing compression across commoditized product formats
• Upside: increased infection-prevention budgets, expanded outpatient wound management, and additional penetration in under-served geographies via low-cost swabs and solutions

Revenue drivers to model

• Volume growth in hospital antisepsis kits and outpatient antiseptic purchases
• Mix shift toward swabs and applicator formats with higher ASP
• Regional growth from healthcare infrastructure expansion and infection prevention standardization
• Incremental product line extensions (gels/ointments, easy-application formats)

What to project

• Unit growth by route: skin antisepsis, wound care, mucosal antisepsis (where approved)
• ASP trends: typically down in highly genericized channels, supported by premium formats
• Competitive pricing: heavy in commodity solution segments, less so in device-integrated or specialty wound-care lines

Key Takeaways

• Povidone iodine clinical activity is largely incremental (formulation and use-optimization studies) rather than novel active-ingredient development.
• Market growth is tied to steady infection-prevention demand and wound care utilization; pricing pressure and protocol substitution (especially chlorhexidine) are recurring headwinds.
• Exclusivity is not meaningful at the active ingredient level; protection, where present, is typically narrow and formulation or device-specific, shifting the commercial risk model toward product-level IP and regulatory execution.
• Revenue projection should be built from unit demand drivers (procedures, wound burden), mix (swabs/applicators vs bulk solution), and pricing dynamics rather than from blockbuster patent protection scenarios.

FAQs

1. What concentration ranges of povidone iodine are most commonly used in wound care and perioperative skin prep?
2. Do povidone-iodine gels and ointments have different infection outcomes than solutions?
3. How do iodine-related safety considerations affect povidone iodine use in neonates or thyroid-compromised patients?
4. Which countries maintain povidone iodine as first-line perioperative antisepsis versus chlorhexidine?
5. What product-format changes (swab vs solution vs gel) most influence ASP and hospital procurement selection?

References

1. Not provided.