Drugs / Valbenazine
Valbenazine
also known as
NBI-98854 · Ingrezza · Ingrezza sprinkle · MT-5199 · NBI-98854 DITOSYLATE · Valbenazina · Valbenazine ditosylate · Valbenazine tosilate · +1 more
Small molecule targets SLC18A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | INGREZZA | — | 2021-04-23 – 2023-08-18 | fda.gov ↗ |
| Approved | US (FDA) | INGREZZA | — | 2017-04-11 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05053321 | Oct 2024 → Oct 2025 | tardive dyskinesia | Yale University | Withdrawn | No outcome recorded |
| Phase 1 | NCT02256475 | Sep 2014 → Nov 2015 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01916993 | Aug → Dec 2013 | — | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01910480 | Jul → Aug 2013 | — | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07111988 | Jun 2026 → Dec 2027 expected | obsessive-compulsive disorder | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06771323 | Dec 2024 → Jun 2027 expected | cervical dystonia | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 2 | NCT05207085 | Feb 2024 → Feb 2027 expected | trichotillomania | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT03732534 | Oct 2018 → Feb 2019 | Tourette syndrome | Neurocrine Biosciences | Terminated | No outcome recorded |
| Phase 2 | NCT03530293 | Apr 2018 → Jul 2019 | Tourette syndrome | Neurocrine Biosciences | Terminated | No outcome recorded |
| Phase 2 | NCT03444038 | Feb 2018 → Jul 2019 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT03325010 | Oct 2017 → Nov 2018 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT02879578 | Jul 2016 → Nov 2017 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT02679079 | Mar 2016 → Apr 2017 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT02581865 | Nov 2015 → Dec 2016 | Tourette syndrome | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT01733121 | Dec 2012 → Dec 2013 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT01688037 | Sep 2012 → Sep 2013 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT01393600 | Aug 2011 → Feb 2012 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT01267188 | Jan → Mar 2011 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03176771 | Jun 2017 → Sep 2020 | tardive dyskinesia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06312189 | Apr 2024 → Apr 2028 expected | Huntington disease | Neurocrine Biosciences | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05654870 | Jan → Nov 2023 | schizophrenia | Neurocrine Biosciences | Terminated | No outcome recorded |
| Phase 3 | NCT05206513 | Apr 2022 → Oct 2025 | cerebral palsy, movement disorder | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT05110157 | Nov 2021 → Feb 2025 | schizophrenia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT04400331 | Sep 2020 → Nov 2025 | Huntington disease | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT04102579 | Nov 2019 → Oct 2021 | Huntington disease | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT02736955 | Jun 2016 → Jun 2017 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT02405091 | Mar 2015 → Mar 2017 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 3 | NCT02274558 | Oct 2014 → Sep 2015 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07105111 | Aug 2025 → Jan 2027 expected | bipolar disorder, major depressive disorder, schizoaffective disorder, schizophrenia +1 | Neurocrine Biosciences | Recruiting | No outcome recorded |
| Phase 4 | NCT06107829 | Jan 2025 → Jan 2027 | developmental disability, intellectual disability, tardive dyskinesia | Stephen Ruedrich | Withdrawn | No outcome recorded |
| Phase 4 | NCT05859698 | May 2023 → Dec 2024 | bipolar disorder, major depressive disorder, schizoaffective disorder, schizophrenia +1 | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 4 | NCT05157100 | Oct 2021 → Sep 2023 | cervical dystonia | The Orthopedic Foundation | Completed | No outcome recorded |
| Phase 4 | NCT03891862 | Mar → Dec 2019 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 4 | NCT03698331 | Sep 2018 → Apr 2019 | tardive dyskinesia | Neurocrine Biosciences | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Valbenazine | “Valbenazine (NBI-98854) is a novel, highly selective vesicular monoamine transporter 2 inhibitor that demonstrated favorable efficacy and tolerability in the treatment of...” PMID 28320223 ↗ Mar 201722“Valbenazine (NBI-98854), a novel compound that selectively inhibits VMAT2, is approved for the treatment of tardive dyskinesia.” PMID 28404690 ↗ Apr 2017 “Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia” NCT05157100 ↗ |
| Known as | Ingrezza | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05157100 ↗ |
| Known as | Ingrezza sprinkle | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Known as | MT-5199 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03176771 ↗ |
| Known as | NBI-98854 | “Valbenazine (NBI-98854) is a novel, highly selective vesicular monoamine transporter 2 inhibitor that demonstrated favorable efficacy and tolerability in the treatment of...” PMID 28320223 ↗ Mar 201711“Valbenazine (NBI-98854), a novel compound that selectively inhibits VMAT2, is approved for the treatment of tardive dyskinesia.” PMID 28404690 ↗ Apr 2017 |
| Known as | NBI-98854 DITOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Known as | Valbenazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Known as | Valbenazine ditosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Known as | Valbenazine tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Known as | VALBENAZINE TOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364639 ↗ |
| Action | Inhibit | “a novel compound that selectively inhibits VMAT2” PMID 28404690 ↗ Apr 20171“Synaptic vesicular amine transporter inhibitor” CHEMBL2364639 ↗ |
| Modality | Small molecule | — CHEMBL2364639 ↗ |
| Route | Oral | “NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.” NCT01688037 ↗ |
| Target | SLC18A2 | “Synaptic vesicular amine transporter inhibitor” CHEMBL2364639 ↗ |