AUSTEDO XR (deutetrabenazine)
Austedo XR helps adults manage involuntary movement disorders, specifically chorea associated with Huntington’s disease and tardive dyskinesia. This medication is used to reduce the severity of these uncontrollable movements, which can significantly impact a patient's daily life. It belongs to a class of drugs known as VMAT2 inhibitors and provides a targeted approach for managing these specific neurological symptoms.
How AUSTEDO XR Works
This medication works by inhibiting VMAT2, a protein that transports monoamines like dopamine and serotonin into synaptic vesicles. By blocking this process, the drug's active metabolites decrease the uptake and storage of these chemicals within nerve terminals. This depletion of monoamine stores is believed to be the primary way the drug helps stabilize motor symptoms.
Details
- Status
- Prescription
- First Approved
- 2023-02-17
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
AUSTEDO XR Approval History
What AUSTEDO XR Treats
3 indicationsAUSTEDO XR is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chorea
- Huntington's Disease
- Tardive Dyskinesia
AUSTEDO XR 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 XR Competitive Set
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Drugs Similar to AUSTEDO XR
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 XR FDA Label Details
Indications & Usage
FDA Label (PDF)AUSTEDO XR 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 XR Patents & Exclusivity
Patents (23 active)
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 1920 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.