Valbenazine

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
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Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities	2023/10/30	NCT06107829	Phase 4	Withdrawn	Stephen Ruedrich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	Recruiting	Neurocrine Biosciences
Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia	2021/12/14	NCT05157100	Phase 4	Completed	The Orthopedic Foundation
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia	2021/11/05	NCT05110157	Phase 3	Completed	Neurocrine Biosciences
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine	2021/09/22	NCT05053321	Phase 1	Withdrawn	Yale University

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.

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