Drugs / Asenapine
Asenapine
also known as
ASE · Asenapina · Asenapine (as maleate) · Asenapine maleate · ORG 5222 · SAPHRIS · Secuado · Sycrest
Other / unclassified targets DRD2, HTR2A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | SAPHRIS | — | 2010-09-03 – 2017-01-13 | fda.gov ↗ |
| Approved | EU (EMA) | Sycrest | — | 2010-09-01 | europa.eu ↗ |
| Approved | US (FDA) | SAPHRIS | — | 2009-08-13 | fda.gov ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01948024 | Jul → Aug 2013 | bipolar disorder, schizophrenia | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01206517 | Jul 2010 → Aug 2011 | bipolar I disorder, schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01807741 | Sep 2013 → Jul 2017 | bipolar depression | University of Cincinnati | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00878462 | Jun → Oct 2005 | psychotic disorder | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT01101464 | Oct → Dec 2002 | schizoaffective disorder, schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 332 trials · 12 met primary · 4 missed | ||||||
| Phase 3 | NCT02876900 | Aug 2016 → Jun 2018 | schizophrenia | Noven Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT01617187 | Dec 2012 → Aug 2014 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01617200 | Dec 2012 → Mar 2015 | schizophrenia | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01765829 | Nov 2012 → Nov 2015 | psychotic disorder | Fundación Pública Andaluza Progreso y Salud | Unknown | No outcome recorded |
| Phase 3 | NCT01684657 | Sep 2012 → May 2014 | stutter disorder | University of California, Irvine | Suspended | No outcome recorded |
| Phase 3 | NCT00764478 | Apr 2012 → Apr 2014 | bipolar I disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01395992 | Apr 2012 → Dec 2014 | bipolar I disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01396291 | Dec 2011 → Apr 2015 | bipolar I disorder | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT01244815 | Jun 2011 → Aug 2013 | bipolar I disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01349907 | Jun 2011 → Sep 2014 | bipolar disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01244828 | Apr 2011 → Aug 2014 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01190267 | Sep 2010 → Oct 2013 | paranoid schizophrenia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT01190254 | Sep 2010 → Mar 2013 | paranoid schizophrenia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT01098110 | May 2010 → Apr 2014 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01142596 | May 2010 → Apr 2015 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00281320 | Feb 2006 → Dec 2008 | psychotic disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00265343 | Dec 2005 → Dec 2007 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00156065 | Sep 2005 → Sep 2007 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00156104 | Jul 2005 → Aug 2006 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00174265 | Jul 2005 → Apr 2009 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00159783 | Jul 2005 → Apr 2007 | bipolar disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00145470 | Jun 2005 → Feb 2007 | bipolar I disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00156117 | May 2005 → Apr 2006 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00212836 | Apr 2005 → Jun 2007 | schizophrenia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00150176 | Apr 2005 → Jun 2008 | schizophrenia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00156091 | Apr 2005 → Jun 2007 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00151424 | Feb 2005 → Jan 2006 | schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00143182 | Jan 2005 → Jun 2006 | bipolar disorder | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00159796 | Dec 2004 → Mar 2006 | bipolar disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00145496 | Dec 2004 → Nov 2008 | schizophrenia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00212771 | Sep 2004 → Sep 2006 | schizoaffective disorder, schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00212784 | Sep 2003 → Mar 2006 | schizoaffective disorder, schizophrenia | Organon and Co | Completed | No outcome recorded |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT01968161 | Oct 2013 → Feb 2014 | schizophrenia | Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec | Unknown | No outcome recorded |
| Phase 4 | NCT01670019 | Oct 2012 → May 2014 | major depressive disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01587118 | Jun 2012 → Jul 2016 | post-traumatic stress disorder | Lori Davis, MD | Completed | No outcome recorded |
| Phase 4 | NCT01400113 | Apr → Dec 2012 | — | Unity Health Toronto | Completed | Met primary |
| Phase 4 | NCT01549041 | Apr 2012 → Apr 2013 | schizophrenia | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01460290 | Oct 2011 → Mar 2014 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT03565068 Background | Jun 2018 → Apr 2020 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02181803 Background | Aug 2014 → Apr 2015 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | Missed primary |
| Phase 3 | NCT00145509 Comparator | Aug 2005 → Dec 2007 | bipolar disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00159744 Comparator | Nov 2004 → Apr 2006 | bipolar disorder | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT07047651 Background | Jun 2025 → Dec 2027 expected | treatment-refractory schizophrenia | Dr. Stavroula Rakitzi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00806234 Comparator | Jan 2009 → Mar 2014 | psychotic disorder | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2020-12-15 | Noven Therapeutics | Results Results from Pivotal, Phase 3 Trial for SECUADO® (asenapine) Published in Journal of Clinical Psychiatry noven.com ↗
The data are published in the January/February 2021 edition of the Journal of Clinical Psychiatry. |
| 2020-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory 11th December, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg. |
| 2019-10-15 | Noven Therapeutics | Regulatory U.S. FDA Approves SECUADO® (asenapine) Transdermal System, the First-and-Only Transdermal Patch for the Treatment of Adults with Schizophrenia noven.com ↗ |
| 2018-12-17 | Noven Therapeutics | Regulatory Notification of a New Drug Application for HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S. noven.com ↗
a New Drug Application has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of HP-3070 (asenapine) transdermal system for the treatment of schizophrenia |
| 2018-01-31 | Noven Therapeutics | Results Notification of the Results of the Phase III Clinical Study of HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S. noven.com ↗
The study results showed that when compared to placebo the investigational product achieved statistically significant improvement from baseline in the change of the total PANSS score at six weeks. |
All press releases naming this drug 12 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asenapine | “Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗49“For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗ “Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.” NCT03319953 ↗ “AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone” NCT03565068 ↗ |
| Known as | ASE | “Data were pooled from intent-to-treat (ITT) populations of three 6-week, randomized controlled studies with fixed doses of asenapine (ASE; n=427), olanzapine (OLA; n=82),...” PMID 25367164 ↗ Apr 2015 |
| Known as | Asenapina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187365 ↗ |
| Known as | Asenapine (as maleate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187365 ↗ |
| Known as | Asenapine maleate | “The study will evaluate low dose Asenapine maleate transdermal patch” NCT02876900 ↗ |
| Known as | ORG 5222 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187365 ↗ |
| Known as | SAPHRIS | “Drug name: SAPHRIS® (Asenapine) sublingual tablets” NCT01948024 ↗ |
| Known as | Secuado | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187365 ↗ |
| Known as | Sycrest | ChEMBL registry synonym — accepted as the source's own label CHEMBL3187365 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3187365 ↗2“Dopamine D2 receptor antagonist” CHEMBL3187365 ↗ “alpha-adrenergic antagonism” PMID 27738377 ↗ Aug 2016 |
| Modality | Other / unclassified | “This is an atypical antipsychotic that blocks dopamine and increases serotonin.” NCT01684657 ↗ |
| Route | Other | “asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID)” NCT00145470 ↗ |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL3187365 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3187365 ↗ |