Drug

Povidone-iodine

Regulatory activity · FDA

Emerging researchLate-stage development

Also known as Aerodine, Antisept, Betadine, Betagen+20 more

Aerodine, Antisept, Betadine, Betagen, Clinidine, Dermawound, Efodine, Iodex, Iodopovidone, Mallisol, Massengill Medicated Douche, Minidyne, Ovadine, PVP-I, PVPI, Pharmadine, Polydine, Povidex, Povidex Peri, Povidine, Summer's Eve Medicated, POVIDONE IODINE, Povidon-iodine, Povidone, iodinated.

RxNorm8611UNII85H0HZU99M

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Recall (Class II): POVIDONE-IODINE 10% TOPICAL

Regulatory2026-06-04FDA

Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

Clinical trial2026-05-22Results expected Q4 2028 · ClinicalTrials.gov

Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial

Clinical trial2026-05-04Results expected Q2 2028 · ClinicalTrials.gov

A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product "Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues Due to the Neuropathic Form of Diabetic Foot Syndrome or Chronic Venous Insufficiency, Phase I-II of the Wound Process

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants：a Randomized Controlled Trial

Clinical trial2026-03-10Results expected Q1 2028 · ClinicalTrials.gov

Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty

Clinical trial2026-02-17Results posted · ClinicalTrials.gov

Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Evaluation of the Decolonization Rate and Acceptance of a Complete Nasal Decolonization Kit With Povidone Iodine for MRSA Patients

Clinical trial2025-12-04Terminated · ClinicalTrials.gov

Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine

Clinical trial2025-12-01Suspended · ClinicalTrials.gov

Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Clinical trial2025-11-19Results expected Q4 2026 · ClinicalTrials.gov

Recall (Class II): POVIDONE-IODINE

Regulatory2024-09-11FDA

Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis.

Research2010-01-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Povidone-iodine

Aliases & brands

AerodineAntiseptBetadineBetagenClinidineDermawoundEfodineIodexIodopovidoneMallisolMassengill Medicated DoucheMinidyneOvadinePVP-IPVPIPharmadinePolydinePovidexPovidex PeriPovidineSummer's Eve MedicatedPOVIDONE IODINEPovidon-iodinePovidone, iodinated

RxNorm CUI

8611

UNII

85H0HZU99M

Regulatory jurisdictions

fda

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 2 events

2026-06-04RecallSafety

Recall (Class II): POVIDONE-IODINE 10% TOPICAL

Evidence ↗

2024-09-11RecallSafety

Recall (Class II): POVIDONE-IODINE

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

66 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 66

Early Phase 14Phase 13Phase 211Phase 2 / 32Phase 312Phase 413Phase N / A21

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial

RecruitingPH IVUniversity of Louisvillen=1482028

Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine

SuspendedPH IVUniversity of Miamin=2302025

Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection

Unknown statusPH IVAssiut Universityn=802024

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty

CompletedPH IVSt. Louis Universityn=602023

Effectiveness of Continuous Application of Lidocaine Cream, Povidone Iodine Cream, and Honey on Second-degree Perineal Tear Healing, a Randomized Controlled Clinical Trial

CompletedPH IVHasanuddin Universityn=2002022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthroplasty

CompletedPH INYU Langone Healthn=2,1292025

IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study

CompletedPH IIAlexandria Universityn=222024

Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial

CompletedPH IRawalpindi Medical Collegen=902023

Effect of Nasal and Oropharyngeal Use of Povidone Iodine and Glycyrrhizin on Ventilator-associated Respiratory Infections: A Randomized Trial

CompletedPH II/IIIMenoufia Universityn=782023

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty

CompletedPH IVSt. Louis Universityn=602023

Betadine Versus Saline in Swapping of Subcutaneous Tissue to Prevent Surgical Site Infection After Caesarian Section

CompletedN/AEgymedicalpedian=3002023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis.

The New England journal of medicine · 2010 · 842 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Chlorhexidine

Frequently co-studied with Povidone-iodine in the research literature.

1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.