Tebipenem Pivoxil (L084) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Numerous completed Phase I through Phase III clinical trials have evaluated the orally bioavailable carbapenem tebipenem pivoxil for complicated urinary tract infections, acute pyelonephritis, skin structure infections, diabetic wound infections, shigellosis, and pharmacokinetic profiles in healthy and renally impaired cohorts. Sponsored by biopharmaceutical entities such as Spero Therapeutics alongside medical centers and international research institutions, these studies systematically characterized the drug's safety, tissue penetration, and efficacy against serious bacterial infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06727136	COMPLETED	Healthy Participants	Spero Therapeutics	2024-11-20	PHASE1
NCT05121974	COMPLETED	Shigellosis	International Centre for Diarrhoeal Disease Research, Bangladesh	2022-08-18	PHASE2
NCT06059846	COMPLETED	Urinary Tract Infection; Acute Pyelonephritis	Spero Therapeutics	2023-12-21	PHASE3
NCT05856747	COMPLETED	Healthy Volunteers	Spero Therapeutics	2023-05-04	PHASE1
NCT04919954	COMPLETED	Diabetes; Wound Infection; ABSSSI; Healthy Volunteers	Hartford Hospital	2021-07-01	PHASE1
NCT04919954	Completed	Diabetes\|Wound Infection\|ABSSSI\|Healthy Volunteers	Hartford Hospital\|Spero Therapeutics	2021-07-01	Phase 1
NCT04376554	COMPLETED	Healthy Volunteers	Spero Therapeutics	2020-02-10	PHASE1
NCT04625855	COMPLETED	Healthy Volunteers	Spero Therapeutics	2020-09-30	PHASE1
NCT04178577	COMPLETED	Renal Impairment	Spero Therapeutics	2019-12-06	PHASE1
NCT04625855	Completed	Healthy Volunteers	Spero Therapeutics\|Covance	2020-09-30	Phase 1
NCT04368585	COMPLETED	Healthy Volunteers	Spero Therapeutics	2020-07-01	PHASE1
NCT04421885	COMPLETED	Healthy Volunteers	Spero Therapeutics	2020-06-01	PHASE1
NCT03788967	COMPLETED	Complicated Urinary Tract Infection; Acute Pyelonephritis	Spero Therapeutics	2019-06-03	PHASE3
NCT04238195	COMPLETED	TQT Study	Spero Therapeutics	2020-01-19	PHASE1
NCT04376554	Completed	Healthy Volunteers	Spero Therapeutics\|Iqvia Pty Ltd	2020-02-10	Phase 1
NCT04178577	Completed	Renal Impairment	Spero Therapeutics	2019-12-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-05-20)

Check the Tebipenem Pivoxil (L084) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tebipenem pivoxil is an orally administered carbapenem prodrug that, upon hydrolysis to tebipenem, selectively binds to and inhibits essential penicillin-binding proteins involved in peptidoglycan cross-linking, leading to structural impairment of the cell wall and subsequent bacterial lysis. This potent bactericidal action disrupts microbial cell wall integrity to suppress bacterial propagation, supporting its clinical application in treating complicated urinary tract infections and acute pyelonephritis.

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>).