AUSTEDO (deutetrabenazine)
Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated in adults for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia. It is designed to manage these hyperkinetic movement disorders by modulating monoamine levels within the central nervous system.
How AUSTEDO Works
The precise mechanism by which deutetrabenazine exerts its effects is unknown, but it is believed to be related to its role as a reversible depletor of monoamines (including dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. Its active metabolites (α-HTBZ and β-HTBZ) are reversible inhibitors of VMAT2, which leads to decreased uptake of monoamines into synaptic vesicles and a subsequent depletion of monoamine stores.
Details
- Status
- Prescription
- First Approved
- 2017-04-03
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
AUSTEDO Approval History
What AUSTEDO Treats
3 indicationsAUSTEDO is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chorea
- Huntington's Disease
- Tardive Dyskinesia
AUSTEDO Boxed Warning
DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their car...
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. 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. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE 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 treatment of chorea when considering the use of AUSTEDO XR or AUSTEDO ( 5.1 ) 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 ) AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or ina
AUSTEDO Competitive Set
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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 |
|---|---|---|---|---|
| NCT04713982 | 200069 | Ph 2, Ph 3 | active not recruiting | Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease |
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.
AUSTEDO FDA Label Details
Indications & Usage
FDA Label (PDF)AUSTEDO is indicated for the treatment of Chorea; Huntington's Disease; Tardive Dyskinesia.
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of d...
AUSTEDO Patents & Exclusivity
Patents (28 active)
Pro Intelligence Preview
Deep insights for AUSTEDO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 288 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.