Penicillin G Sodium Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Penicillin G sodium is evaluated across several clinical trials encompassing Phase 1, Phase 3, and observational studies focused on healthy subjects, infective endocarditis, and syphilis infection associated with benzathine penicillin adverse reactions. Sponsored by academic medical centers such as the Washington University School of Medicine and Uppsala University alongside the pharmaceutical company Pfizer, these investigations range in recruitment status from completed and currently recruiting to not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06391125	Not yet recruiting	Syphilis Infection\|Benzathine Penicillin Adverse Reaction	Washington University School of Medicine	2024-06	Phase 3
NCT04647331	Recruiting	Infective Endocarditis	Uppsala University	2021-06-01	--
NCT03612557	Completed	Healthy	Pfizer	2018-08-20	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Penicillin G Sodium covalently binds to bacterial penicillin-binding proteins, thereby inhibiting the transpeptidase-mediated cross-linking of peptidoglycan chains required for cell wall synthesis. This disruption weakens structural integrity and triggers osmotic cell lysis, providing the bactericidal action necessary to treat severe bacterial diseases such as infective endocarditis and syphilis infection.

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>).