Clinical Trials

A clinical trial sponsored by Entasis Therapeutics evaluated cefpodoxime proxetil in a Phase 1, randomized, double-blind, placebo-controlled setting. The study focused on characterizing the safety, tolerability, and pharmacokinetics of an oral regimen in healthy volunteers. Recruitment for this trial is completed, establishing baseline clinical pharmacology and safety parameters for the compound.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03491748 Completed
Healthy Volunteers
Entasis Therapeutics
 2018-03-16 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefpodoxime proxetil is an oral prodrug that undergoes esterase cleavage to cefpodoxime, which binds to penicillin-binding proteins to block bacterial peptidoglycan cell wall synthesis, resulting in cell lysis and death. This bactericidal mechanism prevents pathogen proliferation, establishing the pharmacological rationale for its safety and pharmacokinetic assessment in healthy volunteer clinical trials.

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.