Saphris

(Asenapine)

ApprovedSmall molecule

Asenapine is an antipsychotic medication used to treat schizophrenia and bipolar I disorder. It helps manage symptoms like abnormal thinking, mood swings, and behavioral changes by adjusting activity of certain brain chemicals.[2] Saphris is currently approved and in use across 3 indications[4].[1]

Saphris is one of 113 small molecule programs targeting Schizophrenia. It is currently in Approved.

Indications

Total Trials

Active Trials

112

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

SchizophreniaCompleted

Bipolar DisorderCompleted

PsychosisCompleted

SchizophreniaApproved

Completed

Bipolar DisorderApproved

Completed

PsychosisApproved

Completed

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Saphris

AbbVie

Approved

10 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Schizophrenia10 trials

Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

Completed·OOrganon and Co·Phase 3·NCT01190267·204 enrolled

Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)

Completed·OOrganon and Co·Phase 3·NCT00212836·481 enrolled

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

Show 7 more trials

Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)

Completed·OOrganon and Co·Phase 3·NCT01142596·201 enrolled

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

Completed·OOrganon and Co·Phase 3·NCT01190254·306 enrolled

6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

Completed·OOrganon and Co·Phase 3·NCT01098110·532 enrolled

Once-Daily Asenapine for Schizophrenia

Completed·—·Phase 4·NCT01549041·30 enrolled

Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

Completed·OOrganon and Co·Phase 3·NCT00145496·468 enrolled

Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

Completed·FForest Laboratories·Phase 3·NCT01617200·105 enrolled

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

Completed·OOrganon and Co·Phase 3·NCT01617187·360 enrolled

Bipolar Disorder7 trials

40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

Completed·OOrganon and Co·Phase 3·NCT00145509·77 enrolled

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Asenapine in the Treatment of Older Adults With Bipolar Disorder

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT01460290·15 enrolled

Show 4 more trials

40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

Completed·OOrganon and Co·Phase 3·NCT00159783·218 enrolled

Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)

Completed·OOrganon and Co·Phase 3·NCT01349907·322 enrolled

Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

Completed·OOrganon and Co·Phase 3·NCT01244815·404 enrolled

12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)

Completed·OOrganon and Co·Phase 3·NCT00145470·326 enrolled

Efficacy and Safety6 trials

Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00156104·460 enrolled

Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

Completed·FForest Laboratories·Phase 3·NCT01396291·561 enrolled

Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

Completed·OOrganon and Co·Phase 3·NCT00151424·277 enrolled

Show 3 more trials

Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)

Completed·OOrganon and Co·Phase 3·NCT00156091·260 enrolled

Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)

Completed·OOrganon and Co·Phase 3·NCT00156065·187 enrolled

Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

Completed·OOrganon and Co·Phase 3·NCT00156117·417 enrolled

Olanzapine5 trials

9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00143182·504 enrolled

3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

Completed·OOrganon and Co·Phase 3·NCT00159744·488 enrolled

6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Completed·OOrganon and Co·Phase 3·NCT00174265·196 enrolled

Show 2 more trials

3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

Completed·OOrganon and Co·Phase 3·NCT00159796·489 enrolled

6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

Completed·OOrganon and Co·Phase 3·NCT00265343·306 enrolled

Schizoaffective Disorder2 trials

Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

Completed·OOrganon and Co·Phase 3·NCT00212771·440 enrolled

Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

Completed·OOrganon and Co·Phase 3·NCT00212784·1,225 enrolled

10 more indications

Psychosis2 trials

Investigator Initiated Study - Asenapine Early Psychosis

Unknown status·—·Phase 4·NCT01968161·12 enrolled

Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

Completed·OOrganon and Co·Phase 3·NCT00281320·122 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Acute1 trial

Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Completed·UUnity Health Toronto·Phase 4·NCT01400113·120 enrolled

Bipolar I Disorder1 trial

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)

Completed·OOrganon and Co·Phase 1·NCT01206517·30 enrolled

Stuttering1 trial

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

Suspended·UUniversity of California, Irvine·Phase 3·NCT01684657·32 enrolled

Bipolar Depression1 trial

Asenapine for Bipolar Depression

Terminated·UUniversity of Cincinnati·Phase 2·NCT01807741·51 enrolled

Treatment Refractory Schizophrenia1 trial

Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

Completed·OOrganon and Co·Phase 3·NCT01244828·157 enrolled

Bipolar 1 Disorder1 trial

Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

Completed·FForest Laboratories·Phase 3·NCT01395992·165 enrolled

Safety and Efficacy1 trial

Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

Completed·OOrganon and Co·Phase 3·NCT00764478·367 enrolled

Unspecified2 trials

Bioequivalence Fasting Study in Patients

Completed·AAmneal Pharmaceuticals, LLC·Phase 2/3·NCT02072954·48 enrolled

Bio-equivalence Study Between SAPHRIS and Asenapine

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 1·NCT01948024·65 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 12, 2015

SAPHRIS

NDA NDA022117

Oct 11, 2019

SECUADO

NDA NDA212268

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Asenapine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Saphris drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Asenapine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Asenapine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212268). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Saphris. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Antagonist; Serotonin 2a (5-Ht2a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Oct 6, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7741358Apr 6, 2026

8022228Apr 6, 2026

7741358*PEDOct 6, 2026

8022228*PEDOct 6, 2026

10022445Jul 25, 2033

5 more patents

9687474Jul 25, 2033

10583121Jul 25, 2033

11123305Jul 25, 2033

10814002Jul 25, 2033

11813364Sep 22, 2033

Saphris

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Schizophrenia10 trials

Bipolar Disorder7 trials

Efficacy and Safety6 trials

Olanzapine5 trials

Schizoaffective Disorder2 trials

Psychosis2 trials

Drug1 trial

Acute1 trial

Bipolar I Disorder1 trial

Stuttering1 trial

Bipolar Depression1 trial

Treatment Refractory Schizophrenia1 trial

Bipolar 1 Disorder1 trial

Safety and Efficacy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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