Clinical Trials

Several clinical trials evaluate tetrabenazine for hyperkinetic and neurodegenerative conditions, focusing primarily on Parkinson's Disease and Tourette's Syndrome across Phase 1/2 and Phase 2 studies. Sponsored by entities including Living Cell Technologies and Bausch Health Americas Inc., these trials exhibit varying recruitment statuses ranging from completed investigations to withdrawn studies. Together, these records document the targeted clinical evaluation profile of tetrabenazine in managing movement disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01734733 Completed
Parkinson''s Disease
Living Cell Technologies
 2013-07-12 Phase 1|Phase 2
NCT01133353 Withdrawn
Tourette''s Syndrome
Bausch Health Americas Inc.
 2011-03 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetrabenazine acts as a reversible, high-affinity inhibitor of vesicular monoamine transporter 2 (VMAT-2) in presynaptic neurons, preventing the packaging of monoamines into synaptic vesicles and promoting the premature metabolic degradation of dopamine. This depletion of presynaptic dopamine reduces involuntary dopaminergic neurotransmission, providing therapeutic relevance for hyperkinetic movement disorders such as Parkinson's Disease and Tourette's Syndrome.

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.