Cefodizime Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate interventions for conditions including serious infections, ceftriaxone poisoning, activated PI3K-delta syndrome (APDS), and PASLI disease, spanning exploratory to combined Phase 2/Phase 3 stages. Sponsoring entities range from public research bodies, such as the Fundación Pública Andaluza para la gestión de la Investigación en Sevilla, to commercial developers like Pharming Technologies B.V. Current recruitment statuses across these studies encompass active but not recruiting as well as unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05061875	Unknown status	Ceftriaxone Poisoning	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	2021-03-01	--
NCT04257812	Unknown status	Serious Infection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	2020-02-15	--
NCT02859727	Active not recruiting	Activated PI3Kdelta Syndrome (APDS); PASLI Disease	Pharming Technologies B.V.	2016-09-08	Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefodizime binds to bacterial penicillin-binding proteins, inhibiting the transpeptidation step essential for peptidoglycan cell wall cross-linking. This disruption destabilizes structural integrity and triggers autolytic enzyme activity, leading to bacterial lysis and providing broad-spectrum bactericidal efficacy to treat serious 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>).