ASENAPINE MALEATE · BRECKENRIDGE
Asenapine maleate is an atypical antipsychotic administered as a sublingual tablet. It is indicated for the treatment of schizophrenia in adults and the management of Bipolar I disorder. Specifically, it is used for the acute monotherapy of manic or mixed episodes in adults and pediatric patients (ages 10–17), as maintenance monotherapy in adults, and as adjunctive treatment to lithium or valproate in adults.
How ASENAPINE MALEATE Works
The exact mechanism of action of asenapine is unknown. However, its efficacy in schizophrenia and Bipolar I disorder is believed to be mediated through a combination of antagonist activity at dopamine D2 and serotonin 5-HT2A receptors. Asenapine exhibits high affinity for a broad range of receptors, acting as an antagonist at serotonin 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6, and 5-HT7 receptors; dopamine D1, D2, D3, and D4 receptors; α1 and α2-adrenergic receptors; and histamine H1 receptors. It possesses no appreciable affinity for cholinergic muscarinic receptors.
Details
- Status
- Prescription
- First Approved
- 2009-08-13
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
ASENAPINE MALEATE Approval History
What ASENAPINE MALEATE Treats
3 indicationsASENAPINE MALEATE is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
ASENAPINE MALEATE Boxed Warning
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. Asenapine sublingual tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1 , 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients...
WARNING: 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. Asenapine sublingual tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1 , 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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. Asenapine sublingual tablets are not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 5.2 )
ASENAPINE MALEATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 ASENAPINE MALEATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
ASENAPINE MALEATE FDA Label Details
Indications & Usage
Asenapine sublingual tablets are indicated for: Schizophrenia in adults [see Clinical Studies ] Bipolar I disorder [see Clinical Studies ] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults Asenapine sublingual tablets are an atypical antipsychotic indicated for : Schizophrenia in adults Bipolar I disorder Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium ...
WARNING: 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. Asenapine sublingual tablets are not approved for the treatment of patients with dementia-related psyc...
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SAPHRIS
Full clinical data, patents, trials, and competitive landscape for asenapine maleate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.