TheraRadar
Data updated: Nov 8, 2026

VALBENAZINE · Novartis

Trial Activity: Stable 5 active trials
CNS
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Development Insights

Neurocrine Biosciences conducting 15 trials (83%)
12 indications explored (Broad Platform)
→ schizophrenia (4 trials)
→ tardive dyskinesia (4 trials)
→ tourette syndrome (4 trials)

Details

Status
None (Tentative Approval)
First Approved
N/A
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Novartis
Active Ingredient: VALBENAZINE

VALBENAZINE Approval History

No approval records found
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Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT06771323 HM20029848 Ph 2 recruiting Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
NCT07105111 NBI-98854-TD4027 Ph 4 recruiting A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
NCT07111988 IRB25-0568 Ph 2 not yet recruiting Valbenazine in Obsessive Compulsive Disorder
NCT05206513 NBI-98854-DCP3018 EUCT Ph 3 completed Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
NCT06312189 NBI-98854-HD3022 Ph 3 enrolling by invitation Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
NCT05110157 NBI-98854-ATS3019 Ph 3 completed Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
NCT05859698 results posted NBI-98854-TD4020 Ph 4 completed Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
NCT05053321 2000031423 No NIH funding Ph 1 withdrawn Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
NCT04400331 NBI-98854-HD3006 Ph 3 terminated Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
NCT05654870 NBI-98854-ATS3020 Ph 3 terminated Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
NCT04102579 KINECT-HD results posted NBI-98854-HD3005 Ph 3 completed Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
NCT03530293 results posted NBI-98854-TS2005 Ph 2 terminated Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
NCT03444038 results posted NBI-98854-TS2004 Ph 2 completed Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
NCT03325010 results posted NBI-98854-TS2003 Ph 2 completed Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
NCT02879578 results posted NBI-98854-1601 Ph 2 completed Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
NCT03891862 results posted NBI-98854-TD4002 Ph 4 completed Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
NCT03698331 results posted NBI-98854-TD4001 Ph 4 completed The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
NCT02736955 results posted NBI-98854-1506 Ph 3 completed Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VALBENAZINE FDA Label Details

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Data Sources

FDA Approval: ANDA215962 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment