Overview

Valbenazine is a modified metabolite of tetrabenazine, and it is currently being approved for the treatment of various movement disorders, particularly tardive dyskinesia and chorea associated with Huntington's disease. Tardive dyskinesia has long been regarded as a consequence of anti-dopamine receptor therapy, and until 2008 with the advent of tetrabenazine, most treatments were ineffective. However, challenges in using tetrabenazine as a treatment of tardive dyskinesia included frequent dosing and safety and tolerability concerns. On April 2017, valbenazine was approved by the FDA under the brand name INGREZZA as the first and only approved treatment for adults with Tardive Dyskinesia (TD). On August 2023, valbenazine was again approved by the FDA for the treatment of chorea associated with Huntington's disease respectively. This approval was supported by positive results in multiple trials, including the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial. The reduction in chorea severity was observed as early as 2 weeks after starting treatment with an initial dose of 40 mg.

Indication

Valbenazine is indicated for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.

Associated Conditions

Chorea
Tardive Dyskinesia (TD)

Research Report

Published: Sep 1, 2025

Valbenazine (DB11915): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Safety Profile

Drug Identification and Physicochemical Properties

Nomenclature and Identifiers

Valbenazine is a small molecule therapeutic agent primarily marketed under the brand name Ingrezza®.[1] Developed by Neurocrine Biosciences, it is also known by its developmental codes NBI-98854 and MT-5199.[4] For unambiguous identification in scientific and regulatory databases, it is assigned the Chemical Abstracts Service (CAS) Number 1025504-45-3, DrugBank Accession Number DB11915, and a Unique Ingredient Identifier (UNII) of 54K37P50KH.[4] Further identifiers include a PubChem CID of 24795069 and a ChEMBL ID of CHEMBL2364639.[4] The proprietary name Ingrezza was conditionally accepted by the U.S. Food and Drug Administration (FDA) on August 31, 2016.[7]

Molecular Profile and Structure

The molecular formula of Valbenazine is C24H38N2O4, with an average molecular weight of approximately 418.58 g/mol.[5] Its systematic International Union of Pure and Applied Chemistry (IUPAC) name isquinolizin-2-yl] (2S)-2-amino-3-methylbutanoate, which precisely defines its complex stereochemistry and constituent functional groups.[6] The molecule's structure is represented by the Simplified Molecular Input Line Entry System (SMILES) string:

CC(C)C[C@@H]1CN2CCC3=CC(=C(C=C3[C@H]2C[C@H]1OC(=O)[C@H](C(C)C)N)OC)OC and the InChIKey GEJDGVNQKABXKG-CFKGEZKQSA-N.[6]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Valbenazine in Obsessive Compulsive Disorder	2025/08/08	NCT07111988	Not Applicable	Not yet recruiting	University of Chicago
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	2025/08/05	NCT07105111	Not Applicable	Not yet recruiting	Neurocrine Biosciences
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia	2025/01/13	NCT06771323	Phase 2	Recruiting	Virginia Commonwealth University
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada	2024/03/15	NCT06312189	Phase 3	ENROLLING_BY_INVITATION	Neurocrine Biosciences
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities	2023/10/30	NCT06107829	Phase 4	Withdrawn	Stephen Ruedrich
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia	2023/05/16	NCT05859698	Phase 4	Completed	Neurocrine Biosciences
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia	2022/12/16	NCT05654870	Phase 3	Terminated	Neurocrine Biosciences
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults	2022/01/26	NCT05207085	Phase 2	Recruiting	Yale University
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy	2022/01/25	NCT05206513	Phase 3	Active, not recruiting	Neurocrine Biosciences
Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia	2021/12/14	NCT05157100	Phase 4	Completed	The Orthopedic Foundation

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
INGREZZA	Neurocrine Biosciences, Inc.	70370-2040	ORAL	40 mg in 1 1	9/25/2023
INGREZZA	Neurocrine Biosciences, Inc.	70370-1060	ORAL	60 mg in 1 1	9/25/2023
INGREZZA	Neurocrine Biosciences, Inc.	70370-1080	ORAL	80 mg in 1 1	9/25/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
REMLEAS HARD CAPSULES 40 MG	Patheon France S.A.S	SIN16198P	CAPSULE, GELATIN COATED	40mg	5/19/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Neurocrine Biosciences Advances CAH Treatment Portfolio with Long-Acting Injectable Therapy

2 months ago

Neurocrine Biosciences initiated Phase 1 trials for NBIP-01435, a long-acting injectable CRF1 receptor antagonist for congenital adrenal hyperplasia (CAH), complementing its recently approved oral therapy CRENESSITY.

Neurocrine Launches Phase 1 Trial of Novel VMAT2 Inhibitor for Neurological Disorders

6 months ago

Neurocrine Biosciences initiates Phase 1 clinical study of NBI-1140675, a second-generation VMAT2 inhibitor, evaluating safety and pharmacokinetics in healthy adults.

Phase 4 KINECT-PRO Trial Shows Ingrezza Significantly Improves Quality of Life in Tardive Dyskinesia Patients

6 months ago

Neurocrine Biosciences' phase 4 KINECT-PRO study demonstrates sustained improvements in physical, social, and emotional impacts of tardive dyskinesia with Ingrezza treatment across all severity levels.

Schizophrenia Market Set for Strong Growth, Driven by Novel Therapies

8 months ago

• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates. • Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics. • The US dominates the schizophrenia market due to a large patient population and high drug costs. • Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.

Neurocrine Biosciences' Crenessity Receives FDA Approval for Congenital Adrenal Hyperplasia

9 months ago

• The FDA has approved Neurocrine Biosciences' Crenessity for treating classic congenital adrenal hyperplasia (CAH) in adults and pediatric patients. • Crenessity is the first corticotropin-releasing factor type 1 receptor (CRF1) antagonist to directly reduce excess adrenocorticotropic hormone (ACTH) and adrenal androgen production. • Goldman Sachs increased Neurocrine's price target to $182, maintaining a Buy rating, citing the approval as a major validation for the company's drug development capabilities. • Crenessity's commercial launch is expedited to the end of this week, and analysts will monitor patient adoption, insurance coverage, and clinical experiences to evaluate its progress.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Valbenazine