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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.

  • A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

    NCT01617187 · start 2012-12-04

    Registered record
    Registry ID
    NCT01617187
    Conditions
    Schizophrenia
    Interventions
    Asenapine; Placebo Asenapine; Olanzapine; Placebo Olanzapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-12-04
    Completion
    2014-09-09
    Enrolment
    360

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

    ConditionSchizophrenia
    InterventionAsenapine; Placebo Asenapine; Olanzapine; Placebo Olanzapine
    PhasePhase 3
    Registry statusCompleted
  • Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

    NCT01617200 · start 2012-12

    Registered record
    Registry ID
    NCT01617200
    Conditions
    Schizophrenia
    Interventions
    Asenapine; Placebo Asenapine; Olanzapine; Placebo Olanzapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-12
    Completion
    2015-03
    Enrolment
    105

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

    ConditionSchizophrenia
    InterventionAsenapine; Placebo Asenapine; Olanzapine; Placebo Olanzapine
    PhasePhase 3
    Registry statusCompleted
  • Observational Post-Authorisation Safety Study of Asenapine (Sycrest)

    NCT01734278 · start 2012-10

    Registered record
    Registry ID
    NCT01734278
    Conditions
    Manic Disorder
    Interventions
    No intervention
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2012-10
    Completion
    2018-01
    Enrolment
    1,000

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

    ConditionManic Disorder
    InterventionNo intervention
    PhaseNot recorded
    Registry statusCompleted
  • Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

    NCT00764478 · start 2012-04-06

    Registered record
    Registry ID
    NCT00764478
    Conditions
    Bipolar 1 Disorder
    Interventions
    Asenapine; Asenapine; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-04-06
    Completion
    2014-05-28
    Enrolment
    367

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

    ConditionBipolar 1 Disorder
    InterventionAsenapine; Asenapine; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

    NCT01395992 · start 2012-04

    Registered record
    Registry ID
    NCT01395992
    Conditions
    Bipolar I Disorder
    Interventions
    asenapine; asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-04
    Completion
    2015-01
    Enrolment
    165

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

    ConditionBipolar I Disorder
    Interventionasenapine; asenapine
    PhasePhase 3
    Registry statusCompleted
  • Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

    NCT01400113 · start 2012-04

    Registered record
    Registry ID
    NCT01400113
    Conditions
    Agitation
    Interventions
    Asenapine; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2012-04
    Completion
    2012-12
    Enrolment
    120

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

    ConditionAgitation
    InterventionAsenapine; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Once-Daily Asenapine for Schizophrenia

    NCT01549041 · start 2012-04

    Registered record
    Registry ID
    NCT01549041
    Conditions
    Schizophrenia
    Interventions
    Asenapine 10 mg daily in the evening; Asenapine 5 mg twice daily
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2012-04
    Completion
    2013-11
    Enrolment
    30

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

    ConditionSchizophrenia
    InterventionAsenapine 10 mg daily in the evening; Asenapine 5 mg twice daily
    PhasePhase 4
    Registry statusCompleted
  • Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

    NCT01396291 · start 2011-12

    Registered record
    Registry ID
    NCT01396291
    Conditions
    Bipolar 1 Disorder
    Interventions
    asenapine; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-12
    Completion
    2015-06
    Enrolment
    561

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

    ConditionBipolar 1 Disorder
    Interventionasenapine; placebo
    PhasePhase 3
    Registry statusCompleted
  • Asenapine in the Treatment of Older Adults With Bipolar Disorder

    NCT01460290 · start 2011-10

    Registered record
    Registry ID
    NCT01460290
    Conditions
    Bipolar Disorder
    Interventions
    Asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2011-10
    Completion
    2014-03
    Enrolment
    15

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

    ConditionBipolar Disorder
    InterventionAsenapine
    PhasePhase 4
    Registry statusCompleted
  • Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

    NCT01244815 · start 2011-06-16

    Registered record
    Registry ID
    NCT01244815
    Conditions
    Bipolar Disorder, Pediatric
    Interventions
    asenapine; Placebo to match asenapine; Rescue medication
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-06-16
    Completion
    2013-09-17
    Enrolment
    404

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

    ConditionBipolar Disorder, Pediatric
    Interventionasenapine; Placebo to match asenapine; Rescue medication
    PhasePhase 3
    Registry statusCompleted
  • Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)

    NCT01349907 · start 2011-06-16

    Registered record
    Registry ID
    NCT01349907
    Conditions
    Bipolar Disorder
    Interventions
    Asenapine; Rescue medication
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-06-16
    Completion
    2014-09-05
    Enrolment
    322

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

    ConditionBipolar Disorder
    InterventionAsenapine; Rescue medication
    PhasePhase 3
    Registry statusCompleted
  • Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

    NCT01244828 · start 2011-04-05

    Registered record
    Registry ID
    NCT01244828
    Conditions
    Schizophrenia
    Interventions
    Asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-04-05
    Completion
    2014-08-21
    Enrolment
    157

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

    ConditionSchizophrenia
    InterventionAsenapine
    PhasePhase 3
    Registry statusCompleted
  • Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

    NCT01190254 · start 2010-09-28

    Registered record
    Registry ID
    NCT01190254
    Conditions
    Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
    Interventions
    asenapine 2.5 mg; asenapine 5.0 mg; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-09-28
    Completion
    2013-04-01
    Enrolment
    306

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

    ConditionSchizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
    Interventionasenapine 2.5 mg; asenapine 5.0 mg; placebo
    PhasePhase 3
    Registry statusCompleted
  • Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

    NCT01190267 · start 2010-09-28

    Registered record
    Registry ID
    NCT01190267
    Conditions
    Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
    Interventions
    asenapine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-09-28
    Completion
    2013-10-07
    Enrolment
    204

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

    ConditionSchizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
    Interventionasenapine
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)

    NCT01206517 · start 2010-07-18

    Registered record
    Registry ID
    NCT01206517
    Conditions
    Schizophrenia; Bipolar I Disorder
    Interventions
    Asenapine 2.5 mg; Asenapine 5 mg; Asenapine 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-07-18
    Completion
    2011-08-04
    Enrolment
    30

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

    ConditionSchizophrenia; Bipolar I Disorder
    InterventionAsenapine 2.5 mg; Asenapine 5 mg; Asenapine 10 mg
    PhasePhase 1
    Registry statusCompleted