TETRABENAZINE
Tetrabenazine helps patients with Huntington’s disease manage chorea, the involuntary jerky movements often associated with the condition. It is used to reduce the severity of these movement symptoms by lowering the levels of specific chemical messengers in the brain. This medication provides a way to address the physical manifestations of the disease, helping to control the dance-like movements that can interfere with daily life.
How TETRABENAZINE Works
This drug works by reversibly inhibiting VMAT2, a transporter responsible for moving monoamines like dopamine and serotonin into storage vesicles within nerve cells. By blocking this process, the medication and its active metabolites deplete the supply of these chemicals at nerve terminals. This reduction in neurotransmitter levels is believed to be the primary way the drug lessens involuntary movements.
Details
- Status
- Prescription
- First Approved
- 2015-08-17
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TETRABENAZINE Approval History
What TETRABENAZINE Treats
1 indicationsTETRABENAZINE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Huntington's Disease
TETRABENAZINE Boxed Warning
DEPRESSION AND SUICIDALITY Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of tetrabenazine must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families shoul...
WARNING: DEPRESSION AND SUICIDALITY Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of tetrabenazine must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. Tetrabenazine is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY See full prescribing information for complete boxed warning . Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.1 ) Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of tetrabenazine tablets ( 5.2 ) Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.1 ) Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.1 ) Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 ) Tetrabenazine tablets are contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression ( 4 , 5.1 )
TETRABENAZINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TETRABENAZINE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01543321 Xeladys | PI11-PR-KRYSTKOWIAK 2011-004211-23 | Ph 3 | completed | Xenazine in Late Dyskinetic Syndrome With Neuroleptics |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TETRABENAZINE FDA Label Details
Indications & Usage
FDA Label (PDF)TETRABENAZINE is indicated for the treatment of Huntington's Disease.
WARNING: DEPRESSION AND SUICIDALITY Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of tetrabenazine must balance the risks of depression and suicidality with the clinical need for co...
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XENAZINE
Full clinical data, patents, trials, and competitive landscape for tetrabenazine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.