Clinical Trials

Several clinical trials, spanning Phase 2, Phase 4, and post-marketing observational designs, have evaluated the efficacy and safety of zonisamide for partial onset, generalized, and combined seizures, as well as noise-induced hearing loss, obstructive sleep apnea, and obesity. These studies were supported by pharmaceutical, academic, and governmental entities, including Eisai Inc., Washington University School of Medicine, Göteborg University, and the United States Department of Defense. Although most trials focusing on seizure management and metabolic or sleep-related evaluations were completed, a study exploring acute noise-induced hearing loss was terminated early.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04774250 Terminated
Hearing Loss Noise-Induced
Washington University School of Medicine|United States Department of Defense|University of Texas|Gateway Biotechnology Inc.
 2021-11-10 Phase 2
NCT01830868 Completed
Partial Onset Seizures
Eisai Inc.
 2012-03 --
NCT01283256 Completed
Partial Generalized and Combined Seizures
Eisai Inc.
 2011-01 --
NCT01765608 Completed
Sleep Apnea|Obstructive Sleep Apnea|Obesity
Göteborg University|Eisai Inc.
 2010-03 Phase 2
NCT00203450 Completed
Obesity
Tuscaloosa Research & Education Advancement Corporation|Eisai Inc.
 2003-05 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zonisamide functions by selectively binding to voltage-gated sodium channels and T-type calcium channels, thereby blocking inward ion fluxes and inhibiting repetitive, high-frequency neuronal firing. This stabilization of hyper-excitable neuronal membranes prevents excessive synchronized discharge, providing direct therapeutic efficacy in mitigating partial-onset seizures and managing conditions studied in clinical trials.

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.