valbenazine
Trade name: ingrezza
Small moleculeapprovedFast Track FDABreakthrough Therapy FDA
Approved
Apr 11, 2017
Valbenazine, sold under the brand name Ingrezza, is a medication used to treat tardive dyskinesia. It acts as a vesicular monoamine transporter 2 (VMAT2) inhibitor. — Wikipedia
Clinical trial activity
34 trials · 9 clinical orgs · 6 marketing orgs
Phase 1
4
Phase 2
23
Phase 3
10
Phase 4
6
Earliest trial started Jan 1, 2011 (NCT01267188)
Timeline
2010s
- Jan 1, 2011
Neurocrine Biosciences — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2013
Neurocrine Biosciences — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Neurocrine Biosciences — Earliest Phase 3 Sponsor(trial)
- Apr 11, 2017
Neurocrine Biosciences — Earliest FDA Approval
- Apr 11, 2017
Neurocrine Biosciences — NDA Secondary Org
- Apr 11, 2017
Neurocrine Biosciences — NDA Organization
2020s
- Oct 13, 2022
Zydus Discovery DMCC — Marketing Organization
- Nov 25, 2022
Teva — Marketing Organization
- Dec 12, 2022
Sandoz — Marketing Organization
- Dec 12, 2022
Novartis — Marketing Organization
- Mar 24, 2023
Lupin — Marketing Organization
Indications
Approved for
Studied for
- Bipolar Disorder · Phase 4
- Cerebral Palsy · Phase 3
- Dermatology · Phase 4
- Developmental Disabilities · Phase 4
- Dyskinesias · Phase 3
- Healthy Volunteers · Phase 1
- Huntington Disease · Phase 3
- Intellectual Disability · Phase 4
- Major Depressive Disorder · Phase 4
- Obsessive-Compulsive Disorder · Phase 2
- Pharmacological and Toxicological Phenomena · Phase 1
- Psychotic Disorders · Phase 4
- Schizophrenia · Phase 4
- Tardive Dyskinesia · Phase 4
- Torticollis · Phase 4
- Tourette Syndrome · Phase 2
- Trichotillomania · Phase 2
Mechanism of action
- Synaptic vesicular amine transporterINHIBITOR
SLC18A2 inhibitor
Approval history
- approvedPriority reviewFast trackBreakthroughApr 11, 2017
Chemistry & pharmacology
Loading structure…
SMILES
COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2.Cc1ccc(S(=O)(=O)O)cc1.Cc1ccc(S(=O)(=O)O)cc1- Mol. weight
- 762.99 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warningProdrug
Sources
- ChEMBLCHEMBL3707248 ↗
- WikipediaValbenazine ↗
- ChEMBLCHEMBL2364639 ↗
Also known as
- ingrezza
- ingrezza
- mt-5199
- nbi-98854
- nbi-98854
- nbi-98854
- nbi-98854
- valbenazine
- valbenazine
- valbenazine
- valbenazine
- valbenazine
- valbenazine
- valbenazine
- valbenazine tosylate
- valine 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2h-benzo(a)quinolizin-2-yl ester
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07111988 | Phase 2 | Oct 31, 2025 | Neurocrine Biosciences, University of Chicago |
| NCT07105111 | Phase 4 | Aug 29, 2025 | Neurocrine Biosciences |
| NCT06771323 | Phase 2 | Mar 31, 2025 | Virginia Commonwealth University |
| NCT06312189 | Phase 3 | Apr 24, 2024 | Neurocrine Biosciences |
| NCT06107829 | Phase 4 | Mar 31, 2024 | Case Western Reserve University, Neurocrine Biosciences |
| NCT05859698 | Phase 4 | May 25, 2023 | Neurocrine Biosciences |
| NCT05654870 | Phase 3 | Jan 31, 2023 | Neurocrine Biosciences |
| NCT05207085 | Phase 2 | Nov 15, 2022 | Neurocrine Biosciences, Yale University |
| NCT05206513 | Phase 3 | Apr 15, 2022 | Neurocrine Biosciences |
| NCT05110157 | Phase 3 | Nov 30, 2021 | Neurocrine Biosciences |
| NCT05053321 | Early Phase 1 (Phase 1) | Nov 30, 2021 | Neurocrine Biosciences, Yale University |
| NCT05157100 | Phase 4 | Oct 19, 2021 | The Orthopedic Foundation |
| NCT04400331 | Phase 3 | Jul 1, 2020 | Huntington Study Group, Neurocrine Biosciences, University of California, San Francisco |
| NCT04102579 | Phase 3 | Nov 30, 2019 | Huntington Study Group, Neurocrine Biosciences |
| NCT03891862 | Phase 4 | Mar 5, 2019 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03732534 | Phase 2 | Oct 17, 2018 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03698331 | Phase 4 | Sep 14, 2018 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03530293 | Phase 2 | Apr 16, 2018 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03444038 | Phase 2 | Feb 8, 2018 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03325010 | Phase 2 | Oct 5, 2017 | Neurocrine Biosciences |
Showing 20 of 34 trials
Page 1 / 2
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Neurocrine Biosciences | For profit | 31 | 27 | 4 | 2011 |
| University of California, San Francisco | Academic/Hospital | 6 | 0 | 3 | 2018 |
| Huntington Study Group | Academic/Hospital | 2 | 0 | 1 | 2019 |
| Yale University | Academic/Hospital | 2 | 2 | 2 | 2021 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Mitsubishi Tanabe | For profit | 1 | 1 | 1 | 2017 |
| The Orthopedic Foundation | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Chicago | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Virginia Commonwealth University | Academic/Hospital | 1 | 1 | 1 | 2025 |
9 organizations
Page 1 / 1
Marketing (10)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Lupin | For profit | MKTG | Mar 24, 2023 |
| Lupin | For profit | SYN | Apr 5, 2024 |
| Neurocrine Biosciences | For profit | NDA2 | Apr 11, 2017 |
| Neurocrine Biosciences | For profit | NDA | Apr 11, 2017 |
| Novartis | For profit | MKTG | Dec 12, 2022 |
| Sandoz | For profit | MKTG | Dec 12, 2022 |
| Teva | For profit | MKTG | Nov 25, 2022 |
| Zydus Discovery DMCC | For profit | SYN | Aug 7, 2024 |
| Zydus Discovery DMCC | For profit | MKTG | Oct 13, 2022 |
| Zydus Discovery DMCC | For profit | SYN | Aug 7, 2024 |