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Asenapine

FDA-approved product (system, transdermal), marketed as Secuado, Asenapine Maleate, Saphris.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

Chemical structure of Asenapine
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Bipolar disorder
  • Bipolar I disorder
  • Psychosis
  • Schizophrenia

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Diazepines, oxazepines, thiazepines and oxepines
FDA pharmacologic class
Atypical Antipsychotic FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA36.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • E. coli32.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae12.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis61.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.0 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.3 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-7.1 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.1 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Asenapine with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.

    NCT07047651 · start 2025-06-04

    Registered record
    Registry ID
    NCT07047651
    Conditions
    Treatment Resistant Schizophrenia; Treatment Resistant Bipolar Disorder
    Interventions
    Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram),; Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants,; Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine; Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2025-06-04
    Completion
    2027-12-20
    Enrolment
    84

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTreatment Resistant Schizophrenia; Treatment Resistant Bipolar Disorder
    InterventionGroup A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram),; Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants,; Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine; Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)
    PhasePhase 4
    Registry statusActive not recruiting
  • A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

    NCT04002700 · start 2019-05-06

    Registered record
    Registry ID
    NCT04002700
    Conditions
    Stroke
    Interventions
    Haloperidol; Typical Antipsychotics; Atypical Antipsychotics
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2019-05-06
    Completion
    2019-05-31
    Enrolment
    1,234,412

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionStroke
    InterventionHaloperidol; Typical Antipsychotics; Atypical Antipsychotics
    PhaseNot recorded
    Registry statusCompleted
  • A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)

    NCT03565068 · start 2018-06-20

    Registered record
    Registry ID
    NCT03565068
    Conditions
    Schizophrenia
    Interventions
    MK-8189; Placebo; Background AAP Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-06-20
    Completion
    2020-04-03
    Enrolment
    75

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia
    InterventionMK-8189; Placebo; Background AAP Therapy
    PhasePhase 1
    Registry statusCompleted
  • A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia

    NCT03319953 · start 2017-12-21

    Registered record
    Registry ID
    NCT03319953
    Conditions
    Stable Schizophrenia
    Interventions
    TAK-041; Placebo; Second Generation Antipsychotics (SGA)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-12-21
    Completion
    2019-11-06
    Enrolment
    23

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionStable Schizophrenia
    InterventionTAK-041; Placebo; Second Generation Antipsychotics (SGA)
    PhasePhase 2
    Registry statusCompleted
  • Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

    NCT02893371 · start 2016-09

    Registered record
    Registry ID
    NCT02893371
    Conditions
    Bipolar Disorder
    Interventions
    Lithium Carbonate; Lamotrigine; Valproic Acid; Oxcarbazepine; Carbamazepine; Ziprasidone; Risperidone; Quetiapine; Olanzapine; Aripiprazole; Fluoxetine / Olanzapine; Haloperidol; Perphenazine; Clozapine; Asenapine; Lurasidone; Paliperidone; Mirtazapine; Bupropion; Desvenlafaxine; Duloxetine; Venlafaxine; Citalopram; Escitalopram; Fluoxetine; Fluvoxamine; Paroxetine; Sertraline; Vilazodone; Doxepin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2016-09
    Completion
    2019-06-30
    Enrolment
    1,037,352

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBipolar Disorder
    InterventionLithium Carbonate; Lamotrigine; Valproic Acid; Oxcarbazepine +26 more
    PhaseNot recorded
    Registry statusTerminated
  • Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.

    NCT02876900 · start 2016-08

    Registered record
    Registry ID
    NCT02876900
    Conditions
    Schizophrenia
    Interventions
    Low Dose Asenapine maleate transdermal patch; High Dose Asenapine maleate transdermal patch; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-08
    Completion
    2018-06
    Enrolment
    617

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia
    InterventionLow Dose Asenapine maleate transdermal patch; High Dose Asenapine maleate transdermal patch; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

    NCT02600741 · start 2015-07-24

    Registered record
    Registry ID
    NCT02600741
    Conditions
    Schizophrenia
    Interventions
    Caregiver psycho-education and skills training; Caregiver support available at the study site; Paliperidone palmitate; Chlorpromazine; Droperidol; Fluphenazine; Haloperidol; Loxapine; Perphenazine; Pimozide; Prochlorperazine; Thiothixene; Thioridazine; Trifluoperazine; Aripiprazole; Asenapine; Clozapine; Iloperidone; Olanzapine; Paliperidone; Quetiapine; Risperidone; Ziprasidone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-07-24
    Completion
    2018-07-05
    Enrolment
    296

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia
    InterventionCaregiver psycho-education and skills training; Caregiver support available at the study site; Paliperidone palmitate; Chlorpromazine +19 more
    PhaseNot recorded
    Registry statusCompleted
  • Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications

    NCT02213887 · start 2014-09

    Registered record
    Registry ID
    NCT02213887
    Conditions
    Psychotic Disorders; Gastroesophageal Reflux
    Interventions
    Pantoprazole; Pantoprazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2014-09
    Completion
    2020-11-02
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPsychotic Disorders; Gastroesophageal Reflux
    InterventionPantoprazole; Pantoprazole
    PhasePhase 4
    Registry statusWithdrawn
  • Elpipodect (MK-8189) Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)

    NCT02181803 · start 2014-08-05

    Registered record
    Registry ID
    NCT02181803
    Conditions
    Schizophrenia
    Interventions
    Elpipodect; Placebo; Base Monotherapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-08-05
    Completion
    2015-04-23
    Enrolment
    55

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia
    InterventionElpipodect; Placebo; Base Monotherapy
    PhasePhase 1
    Registry statusCompleted
  • Bioequivalence Fasting Study in Patients

    NCT02072954 · start 2013-11

    Registered record
    Registry ID
    NCT02072954
    Conditions
    Schizophrenia
    Interventions
    Asenapine Sublingual Tablets 10 mg; Asenapine Sublingual Tablets 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2013-11
    Completion
    2014-06
    Enrolment
    48

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia
    InterventionAsenapine Sublingual Tablets 10 mg; Asenapine Sublingual Tablets 10 mg
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Investigator Initiated Study - Asenapine Early Psychosis

    NCT01968161 · start 2013-10

    Registered record
    Registry ID
    NCT01968161
    Conditions
    Schizophrenia and Disorders With Psychotic Features; Disorders
    Interventions
    Asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2013-10
    Completion
    2014-03
    Enrolment
    12

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia and Disorders With Psychotic Features; Disorders
    InterventionAsenapine
    PhasePhase 4
    Registry statusUnknown
  • Asenapine for Bipolar Depression

    NCT01807741 · start 2013-09

    Registered record
    Registry ID
    NCT01807741
    Conditions
    Bipolar Depression
    Interventions
    Asenapine; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2013-09
    Completion
    2017-07
    Enrolment
    51

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBipolar Depression
    InterventionAsenapine; Placebo
    PhasePhase 2
    Registry statusTerminated
  • Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)

    NCT01495741 · start 2013-07-01

    Registered record
    Registry ID
    NCT01495741
    Conditions
    Bipolar Disorder; Schizophrenia
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2013-07-01
    Completion
    2017-12-18
    Enrolment
    42

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBipolar Disorder; Schizophrenia
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Bio-equivalence Study Between SAPHRIS and Asenapine

    NCT01948024 · start 2013-07

    Registered record
    Registry ID
    NCT01948024
    Conditions
    Schizophrenia; Bipolar Disorder
    Interventions
    SAPHRIS; Asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-07
    Completion
    2013-08
    Enrolment
    65

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSchizophrenia; Bipolar Disorder
    InterventionSAPHRIS; Asenapine
    PhasePhase 1
    Registry statusCompleted
  • An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

    NCT01498770 · start 2013-04-01

    Registered record
    Registry ID
    NCT01498770
    Conditions
    Bipolar Disorder
    Interventions
    Asenapine; Aripiprazole; Quetiapine; Risperidone; Olanzapine; Ziprasidone; Iloperidone; Paliperidone; Lurasidone; Clozapine; Amisulpride; Sertindole; Zotepine
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2013-04-01
    Completion
    2017-12-21
    Enrolment
    42

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBipolar Disorder
    InterventionAsenapine; Aripiprazole; Quetiapine; Risperidone +9 more
    PhaseNot recorded
    Registry statusCompleted