Clinical Trials

Valbenazine tosylate has been evaluated in numerous clinical trials across early- through late-stage phases, investigating hyperkinetic movement disorders and psychiatric conditions such as tardive dyskinesia, Tourette syndrome, and schizophrenia. Sponsored by Neurocrine Biosciences alongside academic institutions, these studies assess dose optimization, long-term safety, and clinician- and patient-reported outcomes. Across these investigations, recruitment statuses include completed, recruiting, enrolling by invitation, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06312189 ENROLLING_BY_INVITATION
Chorea, Huntington
Neurocrine Biosciences
 2024-04-24 PHASE3
NCT07111988 NOT_YET_RECRUITING
Obsessive-Compulsive Disorder
University of Chicago
 2026-06 PHASE2
NCT06771323 RECRUITING
Cervical Dystonia
Virginia Commonwealth University
 2024-12-17 PHASE2
NCT05207085 RECRUITING
Trichotillomania (Hair-Pulling Disorder)
Yale University
 2024-02-02 PHASE2
NCT07105111 RECRUITING
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depressive Disorder; Tardive Dyskinesia
Neurocrine Biosciences
 2025-08-29 PHASE4
NCT06107829 WITHDRAWN
Tardive Dyskinesia; Intellectual Disability; Developmental Disabilities
Stephen Ruedrich
 2025-01 PHASE4
NCT04400331 COMPLETED
Chorea, Huntington
Neurocrine Biosciences
 2020-09-18 PHASE3
NCT05053321 WITHDRAWN
Tardive Dyskinesia
Yale University
 2024-10-18 PHASE1
NCT05206513 COMPLETED
Dyskinesia; Cerebral Palsy
Neurocrine Biosciences
 2022-04-15 PHASE3
NCT05110157 COMPLETED
Schizophrenia
Neurocrine Biosciences
 2021-11-29 PHASE3
NCT05859698 COMPLETED
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depressive Disorder; Tardive Dyskinesia
Neurocrine Biosciences
 2023-05-09 PHASE4
NCT05654870 TERMINATED
Schizophrenia
Neurocrine Biosciences
 2023-01-05 PHASE3
NCT05157100 COMPLETED
Cervical Dystonia
The Orthopedic Foundation
 2021-10-19 PHASE4
NCT04102579 COMPLETED
Chorea, Huntington
Neurocrine Biosciences
 2019-11-13 PHASE3
NCT03891862 COMPLETED
Tardive Dyskinesia (TD)
Neurocrine Biosciences
 2019-03-18 PHASE4
NCT03530293 TERMINATED
Tourette Syndrome
Neurocrine Biosciences
 2018-04-17 PHASE2
NCT03444038 COMPLETED
Tourette Syndrome
Neurocrine Biosciences
 2018-02-08 PHASE2
NCT03698331 COMPLETED
Tardive Dyskinesia (TD)
Neurocrine Biosciences
 2018-09-14 PHASE4
NCT03325010 COMPLETED
Tourette Syndrome
Neurocrine Biosciences
 2017-10-05 PHASE2
NCT02879578 COMPLETED
Tourette Syndrome
Neurocrine Biosciences
 2016-07-25 PHASE2
NCT02736955 COMPLETED
Tardive Dyskinesia
Neurocrine Biosciences
 2016-06-13 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valbenazine tosylate functions as a selective vesicular monoamine transporter 2 (VMAT2) inhibitor with a Ki value of 150 nM, thereby preventing the uptake and storage of monoamines into presynaptic vesicles. This depletion of vesicular dopamine packaging reduces postsynaptic dopamine receptor stimulation, ultimately mitigating involuntary hyperkinetic movements in clinical conditions such as tardive dyskinesia and Tourette 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>).

Jump to

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