Clinical Trials

Several clinical trials sponsored by hospital and university institutions evaluate interventions for conditions such as hypercapnic chronic obstructive pulmonary disease, surgical site infections following acute appendicitis, non-alcoholic steatohepatitis, and cognitive decline. These studies encompass Phase II, Phase IV, and unassigned trial phases affiliated with centers including Hospital Universitario La Paz, Hospital Medina del Campo, Central Hospital Nancy France, and the University of Castilla-La Mancha. Recruitment status across these trials currently ranges from recruiting to not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01037387 Recruiting
Chronic Obstructive Pulmonary Disease|Hypercapnic
Hospital Universitario La Paz
 2025-12 Phase 4
NCT04860570 Recruiting
Acute Appendicitis|Surgical Site Infection
Hospital Medina del Campo
 2024-10-25 --
NCT06160271 Not yet recruiting
Non-alcoholic Steatohepatitis
Central Hospital Nancy France
 2024-09-01 Phase 2
NCT05928078 Not yet recruiting
Cognitive Decline
University of Castilla-La Mancha
 2024-09-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propidium iodide selectively penetrates compromised cellular membranes and intercalates into double-stranded nucleic acids, thereby inhibiting normal DNA-protein interactions and markedly enhancing fluorescent yield. This cell-impermeant fluorescent tagging enables the quantitative detection of membrane-compromised, apoptotic, or necrotic cells, providing analytical value for monitoring tissue injury and cellular degeneration in conditions such as chronic obstructive pulmonary disease, non-alcoholic steatohepatitis, and surgical site infections.

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.