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Valbenazine

Generic Name
Valbenazine
Brand Names
Ingrezza
Drug Type
Small Molecule
Chemical Formula
C24H38N2O4
CAS Number
1025504-45-3
Unique Ingredient Identifier
54K37P50KH

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.

Background

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)

FDA Approved Products

INGREZZA
Manufacturer:Neurocrine Biosciences, Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2023/09/25
NDC:70370-2040
INGREZZA
Manufacturer:Neurocrine Biosciences, Inc.
Route:ORAL
Strength:80 mg in 1 1
Approved: 2023/09/25
NDC:70370-1080
INGREZZA
Manufacturer:Neurocrine Biosciences, Inc.
Route:ORAL
Strength:60 mg in 1 1
Approved: 2023/09/25
NDC:70370-1060

Singapore Approved Products

REMLEAS HARD CAPSULES 40 MG
Manufacturer:Patheon France S.A.S
Form:CAPSULE, GELATIN COATED
Strength:40mg
Online:Yes
Approved: 2021/05/19
Approval:SIN16198P

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