Procaine penicillin G Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials evaluate medical interventions across diverse conditions, including acute ischemic stroke requiring neuroprotection and endovascular treatment, chronic obstructive pulmonary disease, and gastrointestinal neoplasms with enteric nervous system abnormalities. Encompassing Early Phase 1, Phase 2, and unspecified trial classifications, these studies report completed, active recruiting, or unknown recruitment status. Research initiatives are sponsored by academic, medical, and commercial entities, including Capital Medical University, Verona Pharma plc, and the University of Alabama at Birmingham.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05404373	Completed	Stroke Acute\|Neuroprotection\|Endovascular Treatment	Capital Medical University\|Tianjin Huanhu Hospital	2022-06-20	Not Applicable
NCT05270525	Recruiting	COPD	Verona Pharma plc\|University of Alabama at Birmingham	2022-05-27	Phase 2
NCT05232357	Unknown status	Gastrointestinal Neoplasms\|Abnormality of Enteric Nervous System Morphology	Affiliated Hospital to Academy of Military Medical Sciences	2022-03-01	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Procaine penicillin G is a beta-lactam antibiotic complex that binds to penicillin-binding proteins, inhibiting transpeptidase enzymes crucial for bacterial cell wall peptidoglycan cross-linking. This enzymatic blockade compromises cell wall integrity and induces osmotic lysis, delivering bactericidal activity relevant to managing bacterial complications evaluated within clinical studies including chronic obstructive pulmonary disease and acute neuroprotective contexts.

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>).