SECUADO (asenapine)
SECUADO is indicated for the treatment of Schizophrenia.
How SECUADO Works
The exact mechanism of action of asenapine in treating schizophrenia is not fully understood. However, its therapeutic efficacy is believed to be mediated through its activity at specific biological targets. The drug functions as an antagonist, blocking both D2 and 5-HT 2A receptors to produce its clinical effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-11
- Patent Cliff
- 2033
- Routes
- TRANSDERMAL
- Dosage Forms
- SYSTEM
SECUADO Approval History
What SECUADO Treats
1 indicationsSECUADO is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
SECUADO 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. SECUADO is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psyc...
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. SECUADO is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. 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. SECUADO is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )
SECUADO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 SECUADO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01244815 results posted | P06107 | Ph 3 | completed | Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) |
| NCT00764478 results posted | P05691 2010-018409-13, MK-8274-003 | Ph 3 | completed | Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) |
| NCT01617187 results posted | P05688 2010-018407-28 | Ph 3 | completed | A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688) |
| NCT01142596 results posted | P06125 132324 | Ph 3 | completed | Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125) |
| NCT01244828 results posted | P06238 132325, MK-8274-042 | Ph 3 | completed | Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238) |
| NCT01190267 results posted | P05897 2009-018038-12, MK-8274-021 | Ph 3 | completed | Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897) |
| NCT01349907 ADDRESS-98 results posted | P05898 MK-8274-022 | Ph 3 | completed | Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898) |
| NCT01948024 ASN | ASN-101 | Ph 1 | completed | Bio-equivalence Study Between SAPHRIS and Asenapine |
| NCT01807741 | 2012-4181 | Ph 2 | terminated | Asenapine for Bipolar Depression |
| NCT01400113 results posted | P00184 | Ph 4 | completed | Treating Acutely Agitated Patients With Asenapine Sublingual Tablets |
| NCT01396291 | P06384 2010-018671-20 | Ph 3 | completed | Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384) |
| NCT01395992 | P05692 2010-018410-78 | Ph 3 | completed | Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692) |
| NCT01617200 | P05689 2010-018408-96 | Ph 3 | completed | Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689) |
| NCT01460290 results posted | 39358 | Ph 4 | completed | Asenapine in the Treatment of Older Adults With Bipolar Disorder |
| NCT01684657 | Asenapine Stuttering | Ph 3 | suspended | A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering |
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.
SECUADO FDA Label Details
Indications & Usage
FDA Label (PDF)SECUADO is indicated for the treatment of Schizophrenia.
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. SECUADO is not approved for the treatment of patients with dementia-related psychosis [ see Warnings a...
SECUADO Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for SECUADO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 54 active patents
Trial Analysis
- • 17 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment