Clinical Trials

Several clinical trials evaluate clavulanic acid across Phase 1 and Phase 2 stages, focusing on bacterial infections—including pediatric cases—cocaine dependence, and pharmacokinetic bioequivalence. Sponsored by both commercial pharmaceutical developers and academic institutions, these investigations assess antimicrobial safety and therapeutic efficacy. Recruitment statuses span completed pharmacokinetic bioequivalence studies to active, recruiting, and not yet recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05584683 Recruiting
Pediatric|Bacterial Infections
Kaizen Bioscience Co.
 2023-08-09 Phase 1
NCT05340257 Not yet recruiting
Infections Bacterial
GlaxoSmithKline
 2023-06-23 Phase 2
NCT05562349 Active not recruiting
Cocaine Dependence
Temple University|University of Pennsylvania|Medical University of South Carolina|Research Foundation for Mental Hygiene Inc.
 2023-05-03 Phase 2
NCT03702894 Completed
Bioequivalence
Pharmtechnology LLC|ClinPharmInvest LLC
 2018-09-21 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clavulanic acid covalently binds to the active site hydroxyl group of bacterial β-lactamase enzymes, irreversibly inhibiting their catalytic activity and preventing the hydrolytic degradation of co-administered β-lactam antibiotics. By preserving antibiotic structural integrity, this enzymatic blockade restores cell wall synthesis disruption and restores antibacterial efficacy against resistant pathogens in 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>).

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Note: Technical data last updated: Sep 1, 2026.