LURASIDONE HYDROCHLORIDE
Lurasidone hydrochloride tablets are indicated for: • Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ] . • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ].
Details
- Status
- Prescription
- First Approved
- 2019-01-03
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
LURASIDONE HYDROCHLORIDE Approval History
What LURASIDONE HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 2019 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Jan 2019)Letter
- • Approved indication (Jan 2019)
- • Approved indication (Mar 2019)Letter
- • Approved indication (May 2019)
- • Approved indication (Sep 2019)Letter
- • Approved indication (Dec 2020)Letter
- • Approved indication (Feb 2021)
- • Approved indication (May 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2022)
- • Approved indication (Dec 2022)Letter
- • Approved indication (Mar 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Jan 2025)
LURASIDONE HYDROCHLORIDE Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased t...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 ).
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.
LURASIDONE HYDROCHLORIDE FDA Label Details
Indications & Usage
Lurasidone hydrochloride tablets are indicated for: • Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ] . • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ]. Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for th...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...
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Full clinical data, patents, trials, and competitive landscape for lurasidone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.