INGREZZA
Details
- Status
- Prescription
- First Approved
- 2017-04-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE
INGREZZA Approval History
What INGREZZA Treats
2 indicationsINGREZZA is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tardive Dyskinesia
- Huntington's Disease
INGREZZA Boxed Warning
DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depress...
WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them 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 patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. • Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease ( 5.1 ) • Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of INGREZZA or INGREZZA SPRINKLE ( 5.1 ) • Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior ( 5.1 ) • Inform patients, caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them 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 )
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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.
INGREZZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ] . - chorea associated with Huntington’s disease [see Clinical Studies ] . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. - chorea associated with Huntington’s disease.
WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZ...
INGREZZA Patents & Exclusivity
Patents (297 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.