Valbenazine
Also known as Ingrezza, Valbenazine tosylate
NEUROCRINE BIOSCIENCES INC NBIX · Chorea, Huntington; Schizophrenia; Cerebral Palsy; Dyskinesia; Tardive Dyskinesia
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
7
From ClinicalTrials.gov
Latest FDA action
Approved
NDA218390,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NEUROCRINE BIOSCIENCES INC NBIX Source: Company record for NEUROCRINE BIOSCIENCES INC (opens in a new tab)
- Indications
- Chorea, Huntington; Schizophrenia; Cerebral Palsy; Dyskinesia; Tardive Dyskinesia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 218390 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218390 (opens in a new tab)
- NDA 209241 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 209241 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 13 Jun 20167 linked trials
- Filed Completed
- Approved Current stageFirst approval 11 Apr 2017
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Valbenazine. Editors add each one with its source.
Filed application
No filed application is on record for Valbenazine. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Valbenazine.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06312189ClinicalTrials.gov record for NCT06312189 (opens in a new tab) | Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada | Phase 3 | Enrolling by invitation | 7 (estimated) | Apr 2028 (estimated) | No |
| NCT05654870ClinicalTrials.gov record for NCT05654870 (opens in a new tab) | Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia | Phase 3 | Terminated | 8 (actual) | 8 Nov 2023 (actual) | No |
| NCT05206513ClinicalTrials.gov record for NCT05206513 (opens in a new tab) | Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy | Phase 3 | Completed | 86 (actual) | 16 Oct 2025 (actual) | No |
| NCT05110157ClinicalTrials.gov record for NCT05110157 (opens in a new tab) | Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia | Phase 3 | Completed | 442 (actual) | 4 Feb 2025 (actual) | No |
| NCT04400331ClinicalTrials.gov record for NCT04400331 (opens in a new tab) | Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease | Phase 3 | Completed | 154 (actual) | 5 Nov 2025 (actual) | No |
| NCT04102579ClinicalTrials.gov record for NCT04102579 (opens in a new tab)KINECT-HD | Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease | Phase 3 | Completed | 128 (actual) | 15 Oct 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04102579 (opens in a new tab) |
Posted results on ClinicalTrials.gov for KINECT-HD
Serious adverse events (Day 1 (after dosing) through Week 14): Valbenazine 1 of 64; Placebo 2 of 63 Source: ClinicalTrials.gov results for NCT04102579 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing KINECT-HD (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02736955ClinicalTrials.gov record for NCT02736955 (opens in a new tab) | Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia | Phase 3 | Completed | 161 (actual) | 30 Jun 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02736955 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT02736955 Serious adverse events (Up to 60 weeks): Valbenazine 40 mg 3 of 35; Valbenazine 80 mg 11 of 117; Valbenazine 40/80 mg 2 of 8 Source: ClinicalTrials.gov results for NCT02736955 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT02736955 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA218390Action letter for NDA218390 (opens in a new tab) | Original 1 Type 3 - New Dosage Form | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209241Action letter for NDA209241 (opens in a new tab) | Supplement 26 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209241Action letter for NDA209241 (opens in a new tab) | Supplement 20 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209241Action letter for NDA209241 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Valbenazine.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 209241 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06312189 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05654870 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05206513 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05110157 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04400331 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04102579 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02736955 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA218390 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA209241 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.