Betadine

(Povidone-Iodine)

ApprovedSmall molecule

Povidone-Iodine is an antiseptic used to kill bacteria and germs on the skin before surgery or to prevent infection in minor cuts, scrapes, and wounds.[2] Betadine is currently approved and in use across 25 indications[4].[1]

Betadine is one of 263 small molecule programs targeting Acanthamoeba keratitis. It is currently in Approved.

Indications

Total Trials

Active Trials

262

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Acanthamoeba KeratitisApproved

Bacterial DiseaseActive, not recruiting

EmpyemaApproved

Wound HealingActive, not recruiting

Neoplasm of EsophagusActive, not recruiting

AppendicitisApproved

RetinopathyApproved

Viral ConjunctivitisApproved

Skin InfectionActive, not recruiting

ThymomaApproved

Acanthamoeba KeratitisApproved

Approved

Bacterial DiseaseApproved

Active, not recruiting

EmpyemaApproved

Approved

Wound HealingPreclinical

Active, not recruiting

Neoplasm of EsophagusPreclinical

Active, not recruiting

AppendicitisApproved

Approved

RetinopathyApproved

Approved

Viral ConjunctivitisApproved

Approved

Skin InfectionApproved

Active, not recruiting

ThymomaApproved

Approved

Showing 10 of 25 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Betadine

BBecton, Dickinson and Company

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Duragesic

CCephalon

Preclinical

1 6

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Tricor

JJagotec

Preclinical

1 8

Rilvegostomig

AstraZeneca

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Preclinical

—10

Ablavar

LLantheus Medical Imaging

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

White Spot Lesions

NCT06616207

Q3 2027

PreclinicalNot yet recruiting

Dental Implant

NCT07899983

Q4 2027

Phase 3Recruiting

Surgical Site Infection

NCT06302335

Q2 2028

Post-ApprovalNot yet recruiting

Prep

NCT07044726

Clinical

Trials by Indication[1]

COVID-194 trials

Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients

Completed·—·Phase 2·NCT04410159·20 enrolled

A Preventive Treatment for Migrant Workers at High-risk of COVID-19

Completed·NNational University Hospital, Singapore·Phase 3·NCT04446104·4,257 enrolled

Povidone-Iodine Rinses in the Management of COVID-19

Terminated·SSt. Paul's Hospital, Canada·Phase 1·NCT04449965·5 enrolled

Show 1 more trial

Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19

Completed·PPoitiers University Hospital·Phase 2·NCT04371965·24 enrolled

Sepsis3 trials

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Completed·SSeung Duk Lee·Phase 3·NCT01495117·534 enrolled

Topical Antisepsis in Head and Neck Cancer Surgery

Completed·MMedical College of Wisconsin··NCT04721626·25 enrolled

Prostate Biopsy Antisepsis

Completed·UUniversity of British Columbia·N/A·NCT00999427·865 enrolled

Povidone Iodine3 trials

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Terminated·—·Phase 2·NCT01577524·58 enrolled

Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant

Unknown status·—·Phase 1·NCT03957291·100 enrolled

Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing

Completed·HHasanuddin University·Phase 4·NCT05946005·200 enrolled

Chlorhexidine2 trials

Effect of Chlorhexidine on Bacteriuria

Unknown status·MMashhad University of Medical Sciences·Phase 4·NCT02032394·105 enrolled

Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Completed·NNorthwestern University·Phase 4·NCT03305159·134 enrolled

Total Joint Arthroplasty2 trials

Chlorhexidine Versus Betadine in Preventing Colonization of Femoral Nerve Catheters After Total Joint Arthroplasty (TJA)

Withdrawn·NNorthwell Health·N/A·NCT00896402

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

Completed·NNYU Langone Health·Phase 1·NCT04075526·2,129 enrolled

39 more indications

Cesarean Section2 trials

Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

Unknown status·—·N/A·NCT02868372·538 enrolled

Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection

Unknown status·—·Phase 2·NCT02396329·410 enrolled

Effectiveness2 trials

A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions

Completed·UUniversity of Michigan·N/A·NCT01216761·3,879 enrolled

Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA

Unknown status·RRothman Institute Orthopaedics·N/A·NCT02652325

Endometritis2 trials

Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

Completed·FFederal Teaching Hospital Abakaliki·N/A·NCT06936475·239 enrolled

Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?

Completed·EErzincan Military Hospital·Phase 4·NCT01437228·668 enrolled

Colonization2 trials

Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections

Completed·UUniversity of Virginia·N/A·NCT01886001·53 enrolled

Umbilical Cord Care for the Prevention of Colonization

Unknown status·UUniversity of Virginia·N/A·NCT01893060·100 enrolled

Pain Management1 trial

Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion

Completed·UUniversity of New Mexico·N/A·NCT02391714·80 enrolled

Thermal Burns1 trial

The Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns

Unknown status·MMeir Medical Center·N/A·NCT01350713·280 enrolled

Wound Healing1 trial

Topical Insulin for Postoperative Wound Healing

Active, not recruiting·—·N/A·NCT06400082·74 enrolled

Recurrence1 trial

Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection

Completed·TTechnische Universität Dresden·N/A·NCT02676791·80 enrolled

Ventilator-Associated Pneumonia1 trial

Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia

Completed·MMenoufia University·Phase 2/3·NCT05895773·78 enrolled

Corneal Ulcer1 trial

A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 2·NCT00386958·172 enrolled

Total Shoulder Arthroplasty1 trial

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

Completed·SSt. Louis University·Phase 4·NCT05919888·60 enrolled

Treatment1 trial

Parasitic Ulcer Treatment Trial Pilot

Unknown status·UUniversity of California, San Francisco·Phase 2·NCT03484507·49 enrolled

Hysteroscopy1 trial

Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

Completed·—·Phase 3·NCT02713074·147 enrolled

Caesarean Section1 trial

Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section

Completed·FFederal Teaching Hospital Abakaliki·N/A·NCT06950229·224 enrolled

Hemorrhage1 trial

Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit

Terminated·RRennes University Hospital·Phase 3·NCT00950027·179 enrolled

Blepharitis1 trial

Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Terminated·SSouthern California Institute for Research and Education·N/A·NCT01560962·100 enrolled

Tics1 trial

Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

Completed·CC. R. Bard·Phase 3·NCT00692484·122 enrolled

Spine Surgery1 trial

Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Completed·—·Phase 4·NCT02527512·173 enrolled

Vaginal Delivery1 trial

Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery

Not yet recruiting·SSeoul National University Hospital·N/A·NCT05122169·4,140 enrolled

Adjuvant Therapy1 trial

Povidone-Iodine Rinses as an Adjuvant Therapy Post-Operatively

Unknown status·SSt. Paul's Hospital, Canada·N/A·NCT04278950·100 enrolled

Surgical Site Infections1 trial

Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Recruiting·LLoma Linda University·Phase 3·NCT06363877·1,100 enrolled

Postoperative Infections1 trial

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Completed·—·Phase 3·NCT00290290·849 enrolled

PrEP1 trial

Betadine vs Sterile Water for Periurethral Preparation

Not yet recruiting·UUniversity of Louisville·Phase 4·NCT07044726·148 enrolled

Breast Cancer1 trial

Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine

Completed·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 4·NCT02479347·2,158 enrolled

Keratoconjunctivitis1 trial

Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

Completed·MMinia University·N/A·NCT04169919·350 enrolled

OSA1 trial

Betadine Effect on Nasal Mucosa Cilia

Withdrawn·—·Phase 1·NCT04457765

Dialysis Patients1 trial

Nasal Decolonization of Dialysis Patients Noses

Active, not recruiting·MMarin L. Schweizer, PhD·Phase 4·NCT04210505·302 enrolled

Laparoscopy1 trial

Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in Laparoscopy

Completed·—·Phase 2·NCT02591251·100 enrolled

Catheter1 trial

Betadine Pleurodesis Via Tunneled Pleural Catheters

Withdrawn·YYale University·Phase 4·NCT02975921

Chronic Rhinosinusitis1 trial

Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

Completed·SSt. Paul's Hospital, Canada·Phase 1·NCT04097613·29 enrolled

Surgical Site Infection1 trial

Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

Recruiting·HHospital de Clinicas de Porto Alegre·Phase 3·NCT06302335·228 enrolled

Pseudomonas Aeruginosa1 trial

Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants

Enrolling by invitation·JJianyi Li·N/A·NCT07460297·100 enrolled

Prospective1 trial

A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Unknown status·SSeoul National University Hospital·Phase 4·NCT02245334·1,578 enrolled

Otomycosis1 trial

Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment

Completed·RRawalpindi Medical College·Phase 1·NCT06339294·90 enrolled

Dental Implant1 trial

Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome

Not yet recruiting·MMadigan Army Medical Center·Preclinical·NCT07899983·60 enrolled

Corona Virus Infection1 trial

Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?

Completed·HHampshire Hospitals NHS Foundation Trust·Phase 1·NCT04393792·58 enrolled

White Spot Lesions1 trial

Efficacy and Safety of Topical 10% Povidone-Iodine in Preventing White Spots During Orthodontic Treatment

Active, not recruiting·UUniversity of Washington·Phase 2·NCT06616207·80 enrolled

Empyema, Pleural1 trial

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

Completed·AAlexandria University·Phase 2·NCT05546762·22 enrolled

Unspecified1 trial

PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

Active, not recruiting·LLoreen Herwaldt·Phase 4·NCT05763602·2,000 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 29, 1985

E-Z SCRUB 201

NDA NDA019240

Dec 17, 1986

BETADINE

NDA NDA018634

Jan 7, 1987

E-Z SCRUB 241

NDA NDA019476

Mar 31, 1989

POVIDONE IODINE

NDA NDA019522

Jul 25, 1989

E-Z PREP

NDA NDA019382

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Povidone-Iodine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Betadine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Povidone-Iodine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Povidone-Iodine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019382). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Becton, Dickinson and Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBecton, Dickinson and Company

Betadine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

COVID-194 trials

Sepsis3 trials

Povidone Iodine3 trials

Chlorhexidine2 trials

Total Joint Arthroplasty2 trials

Cesarean Section2 trials

Effectiveness2 trials

Endometritis2 trials

Colonization2 trials

Pain Management1 trial

Thermal Burns1 trial

Wound Healing1 trial

Recurrence1 trial

Ventilator-Associated Pneumonia1 trial

Corneal Ulcer1 trial

Total Shoulder Arthroplasty1 trial

Treatment1 trial

Hysteroscopy1 trial

Caesarean Section1 trial

Hemorrhage1 trial

Blepharitis1 trial

Tics1 trial

Spine Surgery1 trial

Vaginal Delivery1 trial

Adjuvant Therapy1 trial

Surgical Site Infections1 trial

Postoperative Infections1 trial

PrEP1 trial

Breast Cancer1 trial

Keratoconjunctivitis1 trial

OSA1 trial

Dialysis Patients1 trial

Laparoscopy1 trial

Catheter1 trial

Chronic Rhinosinusitis1 trial

Surgical Site Infection1 trial

Pseudomonas Aeruginosa1 trial

Prospective1 trial

Otomycosis1 trial

Dental Implant1 trial

Corona Virus Infection1 trial

White Spot Lesions1 trial

Empyema, Pleural1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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