Clinical Trials

Multiple clinical trials investigate therapeutic applications across Phase 2, Early Phase 1, and non-applicable phase classifications. These studies focus on conditions including acute ischemic stroke with neuroprotection during endovascular treatment, chronic obstructive pulmonary disease, and gastrointestinal neoplasms with enteric nervous system abnormalities. Sponsored by academic institutions and industry entities such as Capital Medical University and Verona Pharma plc, these trials report recruitment statuses ranging from actively recruiting and completed to unknown.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Penicillin G Procaine binds specifically to bacterial penicillin-binding proteins, thereby inhibiting transpeptidase-mediated peptidoglycan cross-linking required for bacterial cell wall synthesis. This molecular inhibition compromises structural integrity and induces osmotic lysis in bacterial cells, offering critical antibacterial therapeutic support in clinical contexts such as acute stroke, chronic obstructive pulmonary disease, and gastrointestinal neoplasms.

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.