Clinical Trials

Multiple clinical trials evaluate povidone iodine across diverse therapeutic and prophylactic applications, including SARS-CoV-2 acute respiratory disease, MRSA nasal colonization, surgical site or wound infections, and diagnostic parameters in healthy individuals. Spanning Phase 2, Phase 4, and non-interventional designs, these studies encompass recruitment statuses ranging from withdrawn and not yet recruiting to active, not recruiting, and unknown. The trials are sponsored by academic institutions and industry partners, including Nantes University Hospital, Ain Shams University, Hasan Kalyoncu University, the University of Iowa, and 3M.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05745467 Withdrawn
SARS-CoV-2 Acute Respiratory Disease
University of Iowa|3M
 2024-07-03 Phase 4
NCT05696132 Not yet recruiting
MRSA
Nantes University Hospital
 2023-02 Phase 2
NCT05704959 Active not recruiting
HEALTHY INDIVIDUALS
Hasan Kalyoncu University
 2022-03-15 Not Applicable
NCT05077592 Unknown status
Surgical Site Infection|Surgical Wound Infection
Ain Shams University
 2021-09-18 Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Povidone iodine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Povidone iodine functions by gradually releasing free elemental iodine, which rapidly penetrates microbial cell walls and oxidizes essential structural proteins, enzymes, and membrane lipids to disrupt critical biological processes. This potent, non-specific microbicidal action leads to cell lysis, providing the mechanistic foundation for its clinical evaluation in reducing surgical site infections, eradicating nasal MRSA, and limiting SARS-CoV-2 mucosal burden.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.