Valbenazine Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Numerous clinical trials evaluate valbenazine across Phase 1 through Phase 4 to assess its efficacy and safety in tardive dyskinesia, Tourette syndrome, Huntington's disease chorea, cervical dystonia, and as adjunctive treatment for schizophrenia, bipolar disorder, major depressive disorder, and obsessive-compulsive disorder. Sponsored by industry leaders such as Neurocrine Biosciences alongside academic institutions including Yale University, the University of Chicago, and Virginia Commonwealth University, these studies report varying recruitment statuses, including completed, currently recruiting, terminated, withdrawn, and enrolling by invitation.

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NCT06107829	WITHDRAWN	Tardive Dyskinesia; Intellectual Disability; Developmental Disabilities	Stephen Ruedrich	2025-01	PHASE4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NCT05053321	WITHDRAWN	Tardive Dyskinesia	Yale University	2024-10-18	PHASE1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 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valbenazine selectively binds to and inhibits vesicular monoamine transporter 2 (VMAT2), thereby blocking the presynaptic packaging and storage of monoamines such as dopamine within synaptic vesicles. This inhibition reduces synaptic dopamine release and dampens postsynaptic dopamine receptor stimulation, ultimately mitigating hyperkinetic involuntary movements in clinical trial conditions such as tardive dyskinesia, Tourette syndrome, and Huntington's disease chorea.

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>).