drug
as of 2026-07-01Asenapine
asenapine 2.5 mgasenapine 5.0 mgAsenapine WHITE raspberry flavor (Treatment A)Asenapine RED raspberry flavor (Treatment B)Asenapine WHITE UNFLAVORED (Treatment C)Asenapine 2.5 mgAsenapine 5 mgAsenapine 10 mg
MeSH C522667UNII CU9463U2E2RxCUI 859975, 859979, 859981, 859983, 1606337, 1606490FDA_ApplNo NDA022117SPL_set_id 5429f134-839f-4ffc-9944-55f51238def8FDA_sponsor ABBVIEOrangeBook_Appl A205960, A206098, A206107, N022117, N212268
at a glance
small molecule
US-approved (2009) as SAPHRIS
Developed by Organon and Co
Orange Book protection to 2033
30 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Mechanism of action
12.1 Mechanism of Action The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination of antagonist activity at D 2 and 5-HT 2A receptors.
Indications
Labeled
SchizophreniaBipolar depressionBipolar maniaMajor depressive disorder
Investigational (via trials)
SchizophreniaDiseasePsychosisDisordersSchizophrenia Spectrum and Other Psychotic DisordersAgitationSchizophrenia, DisorganizedBipolar DisorderPsychomotor AgitationSchizophreniaSchizophrenia, ParanoidSchizophrenia, DisorganizedDisorders of Sex DevelopmentBipolar DisorderPsychotic DisordersBipolar I Disorder
Patents & exclusivity
Orange Book
patent 118133642033-09-22
patent 10814002 · U-27632033-07-25
patent 111233052033-07-25
patent 100224452033-07-25
patent 96874742033-07-25
patent 10583121 · U-27632033-07-25
patent 7741358*PED2026-10-06
patent 8022228*PED2026-10-06
patent 7741358 · U-19602026-04-06
patent 80222282026-04-06
Adverse-event signal
FAERS spontaneous · within-drug share
Eps Akathisia9.8%
top term: DYSKINESIA
Weight Metabolic9.1%
top term: WEIGHT INCREASED
Sedation5.9%
top term: SEDATION
Mortality4.5%
top term: SUICIDE ATTEMPT
Gi2.6%
top term: NAUSEA
Prolactin2.0%
top term: BLOOD PROLACTIN ABNORMAL
Hematologic0.8%
top term: LEUKOPENIA
Orthostatic0.7%
top term: HYPOTENSION
Anticholinergic0.3%
top term: CONSTIPATION
Qt Cardiac0.3%
top term: ELECTROCARDIOGRAM QT PROLONGED
Spontaneous reports — a signal of reporting share, not incidence.
Trials
30
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
NCT02876900Phase 3Completed
Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
NCT01142596Phase 3Completed
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
NCT01617200Phase 3Completed
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
NCT01244828Phase 3Completed
A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
NCT01617187Phase 3Completed
6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)
NCT01098110Phase 3Completed
Investigator Initiated Study - Asenapine Early Psychosis
NCT01968161Phase 4Unknown
Bioequivalence Fasting Study in Patients
NCT02072954Phase 2, Phase 3Completed
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
NCT01190267Phase 3Completed
Bio-equivalence Study Between SAPHRIS and Asenapine
NCT01948024Phase 1Completed
Once-Daily Asenapine for Schizophrenia
NCT01549041Phase 4Completed
Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
NCT01190254Phase 3Completed
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
NCT01400113Phase 4Completed
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
NCT01206517Phase 1Completed
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
NCT00174265Phase 3Completed
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
NCT00281320Phase 3Completed
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
NCT00145496Phase 3Completed
To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
NCT00150176Phase 3Completed
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
NCT00265343Phase 3Completed
Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
NCT00156065Phase 3Completed
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
NCT00212836Phase 3Completed
Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)
NCT00156091Phase 3Completed
KOLs & investigators
12
Facts & assertions
27 sourced
Anda Generic Count
8
Boxed Warning
present
Dosing Frequency
twice daily
Faers Share Anticholinergic
0.003
Faers Share Eps Akathisia
0.098
Faers Share Gi
0.027
Faers Share Hematologic
0.008
Faers Share Mortality
0.045
Faers Share Orthostatic
0.007
Faers Share Prolactin
0.02
Faers Share Qt Cardiac
0.003
Faers Share Sedation
0.059
Faers Share Weight Metabolic
0.091
Has Generic Competition
yes
Latest Patent Expiry
2033-09-22
Latest Protection Date
2033-09-22
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination of antagonist activity at D 2 and 5-HT 2A receptors.
Originator Company
Abbvie
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2009-08-13
relationships
The graph out of here
developer
company
trial
indication
KOL
David P Walling, PhD
personKOL score 17
Laura Leso, MD
personKOL score —
Ashutosh Jani, MD
personKOL score —
James S. McDonough, MD
personKOL score —