Benzathine penicilline Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple Phase 3 clinical trials sponsored by academic medical centers, including the Washington University School of Medicine and National Taiwan University Hospital, investigate benzathine penicillin for early syphilis. These studies encompass a completed trial evaluating serologic responses to standard regimens and an upcoming, not-yet-recruiting study assessing lidocaine co-administration to reduce adverse reactions from intramuscular therapy. Together, these efforts aim to optimize treatment outcomes and injection tolerability against Treponema pallidum.

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
NCT01944358	Completed	Serologic Response of Syphilis\|Early Syphilis\|High Risk Behavior	National Taiwan University Hospital\|Far Eastern Memorial Hospital\|Taichung Veterans General Hospital\|National Cheng-Kung University Hospital\|Chang Gung Memorial Hospital\|Chi Mei Medical Hospital\|Kaohsiung Medical University Chung-Ho Memorial Hospital\|E-DA Hospital	2007-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzathine penicillin binds to bacterial penicillin-binding proteins, inhibiting transpeptidase enzymes required for peptidoglycan synthesis and cell wall cross-linking. The resulting loss of structural integrity leads to bacterial cell lysis and death, mediating therapeutic clearance of Treponema pallidum in 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>).