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ASENAPINE MALEATE
ASENAPINE MALEATE is a drug. It is currently FDA-approved (first approved 2009).
At a glance
| Generic name | ASENAPINE MALEATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2009 |
Approved indications
Boxed warnings
- 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 )
Common side effects
- Somnolence
- Oral hypoesthesia
- Akathisia
- Dizziness
- Extrapyramidal symptoms
- Dysgeusia
- Nausea
- Increased appetite
- Fatigue
- Increased weight
Drug interactions
- Antihypertensive Drugs
- Strong CYP1A2 Inhibitors (e.g., Fluvoxamine)
- CYP2D6 substrates and inhibitors (e.g., paroxetine)
Key clinical trials
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
- An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED) (PHASE2)
- 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) (PHASE3)
- Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED) (PHASE3)
- 3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009) (PHASE3)
- 3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008) (PHASE3)
- Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ASENAPINE MALEATE CI brief — competitive landscape report
- ASENAPINE MALEATE updates RSS · CI watch RSS
Frequently asked questions about ASENAPINE MALEATE
What is ASENAPINE MALEATE?
ASENAPINE MALEATE is a Small molecule drug.
When was ASENAPINE MALEATE approved?
ASENAPINE MALEATE was first approved on 2009.
What development phase is ASENAPINE MALEATE in?
ASENAPINE MALEATE is FDA-approved (marketed).
What are the side effects of ASENAPINE MALEATE?
Common side effects of ASENAPINE MALEATE include Somnolence, Oral hypoesthesia, Akathisia, Dizziness, Extrapyramidal symptoms, Dysgeusia.
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