Biapenem Clinical Trials

Size	Price	Qty
25mg	USD 119
100mg	USD 227

Clinical Trials

A clinical trial evaluated the safety, tolerability, and pharmacokinetic properties of ascending single and multiple doses of Biapenem, a broad-spectrum carbapenem antibiotic. Sponsored by Rempex Pharmaceuticals, this completed Phase 1 study utilized a randomized, double-blind, placebo-controlled design in healthy volunteers to establish preliminary safety data relevant to treating bacterial infections. The investigation represents the primary recorded clinical assessment of the agent's pharmacological profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01772836	Completed	Healthy Volunteers\|Bacterial Infections	Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)	2013-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Biapenem is a broad-spectrum carbapenem antibiotic that binds to essential penicillin-binding proteins, thereby blocking peptidoglycan cross-linking during bacterial cell wall synthesis. This disruption of cell wall integrity leads to osmotic lysis and rapid bacterial cell death, providing the mechanistic rationale for its clinical evaluation against bacterial 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>).