Drugs / Clozapine
Clozapine
also known as
Clozapina · Clozapine (caraco) · Clozapine (clozaril) · Clozapine (fazaclo) · Clozapine (ivax) · Clozapine (mylan) · Clozapine (teva) · Clozapine (udl) · +12 more
Other / unclassified targets DRD2, HTR2A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CLOZAPINE | — | 2010-04-15 | fda.gov ↗ |
| Label expansion | US (FDA) | CLOZARIL | — | 2002-12-18 | fda.gov ↗ |
| Approved | US (FDA) | CLOZARIL | — | 1989-09-26 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06596681 | Sep 2024 → Mar 2026 overdue | neuropathy, painful | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06993662 | Jun 2025 → Dec 2027 expected | anxiety, bipolar disorder, depressive disorder, obsessive-compulsive disorder +3 | Rakitzi, Stavroula | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01654601 | Jun 2012 → Apr 2013 | schizophrenia | Dong Wha Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04529226 | Nov 2020 → Jan 2025 | intellectual disability, psychotic disorder | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 2 | NCT00029458 | Jan 2002 → Oct 2005 | bipolar disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 2 | NCT00154258 | Apr 2001 → Dec 2009 | schizophrenia | Novartis | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05603104 | Apr 2025 → Jun 2028 expected | bipolar depression, major depressive disorder, schizophrenia | Dr. Inge Winter | Recruiting | No outcome recorded |
| Phase 3 | NCT04528095 | Dec 2020 → Dec 2022 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 3 | NCT03510325 | Feb 2019 → Sep 2023 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01765829 | Nov 2012 → Nov 2015 | psychotic disorder | Fundación Pública Andaluza Progreso y Salud | Unknown | No outcome recorded |
| Phase 3 | NCT00250575 | Nov 2005 → Dec 2009 | schizophrenia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00036582 | May 2002 → Feb 2004 | bipolar disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 3 | NCT00065273 | Jul 1998 → Jun 2001 | developmental disability | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 3 | NCT00189995 | — | schizophrenia | Beersheva Mental Health Center | Withdrawn | No outcome recorded |
| Phase 420 trials · 3 missed | ||||||
| Phase 4 | NCT05958875 | Aug 2024 → Jun 2028 expected | schizophrenia | Dr. Inge Winter | Recruiting | No outcome recorded |
| Phase 4 | NCT05741502 | Aug 2023 → Jan 2026 | schizophrenia | Ohio State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05208190 | Mar 2022 → Jun 2028 expected | schizoaffective disorder, schizophrenia | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04580134 | Mar 2022 → Apr 2027 expected | bipolar I disorder, schizoaffective disorder, schizophrenia | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05316883 | Feb 2021 → Dec 2029 expected | schizophrenia | Jimmi Nielsen | Recruiting | No outcome recorded |
| Phase 4 | NCT03857581 | Jul 2020 → Jul 2021 | psychotic disorder, substance-related disorder | Augusta University | Unknown | No outcome recorded |
| Phase 4 | NCT02639702 | Aug 2016 → Dec 2026 expected | schizoaffective disorder, schizophrenia | Centre for Addiction and Mental Health | Recruiting | No outcome recorded |
| Phase 4 | NCT02562287 | Oct 2015 → Jun 2019 | bipolar disorder | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 4 | NCT02625103 | Sep → Dec 2015 | schizophrenia | Anders Fink-Jensen, MD, DMSci | Completed | No outcome recorded |
| Phase 4 | NCT02286206 | Jan 2015 → Dec 2017 | schizophrenia | University of British Columbia | Withdrawn | No outcome recorded |
| Phase 4 | NCT01639872 | May 2013 → Mar 2017 | cannabis dependence, schizophrenia, substance abuse | Dartmouth-Hitchcock Medical Center | Completed | Missed primary |
| Phase 4 | NCT01663077 | Oct 2012 → Nov 2016 | schizophrenia | Tirat Carmel Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT01248195 | May 2011 → Apr 2016 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Rene Kahn | Completed | Missed primary |
| Phase 4 | NCT00501618 | Nov 2006 → Mar 2009 | schizoaffective disorder, schizophrenia | Manhattan Psychiatric Center | Completed | No outcome recorded |
| Phase 4 | NCT00014001 | Dec 2000 → Dec 2004 | schizophrenia | National Institute of Mental Health (NIMH) | Completed | Mixed |
| Phase 4 | NCT00498550 | Oct 2000 → Mar 2009 | schizoaffective disorder, schizophrenia, substance abuse | Dartmouth-Hitchcock Medical Center | Completed | Missed primary |
| Phase 4 | NCT02640300 | May 1999 → Jul 2004 | schizoaffective disorder, schizophrenia | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 4 | NCT00169026 | May 1999 → Jan 2004 | alcohol abuse, schizoaffective disorder, schizophrenia | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT00169091 | Mar 1996 → Sep 2003 | schizophrenia | Harvard Medical School (HMS and HSDM) | Terminated | No outcome recorded |
| Phase 4 | NCT00169039 | Dec 1994 → Feb 2002 | schizophrenia | Harvard Medical School (HMS and HSDM) | Terminated | No outcome recorded |
| Phase not applicable7 trials · 2 met primary | ||||||
| — | NCT02404155 | Jul 2015 → Oct 2021 | schizophrenia | University of Maryland, Baltimore | Completed | Met primary |
| — | NCT01448499 | Oct 2011 → Oct 2013 | treatment-refractory schizophrenia | Geha Mental Health Center | Withdrawn | No outcome recorded |
| — | NCT00493233 | Nov 2006 → Dec 2008 | schizophrenia | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| — | NCT00573287 | Jun 2006 → Dec 2010 | schizophrenia, substance-related disorder | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| — | NCT00179231 | May 2000 → Feb 2004 | schizoaffective disorder, schizophrenia | Vanderbilt University | Completed | No outcome recorded |
| — | NCT01123408 | Jun 1999 → Jul 2004 | schizophrenia | Nathan Kline Institute for Psychiatric Research | Completed | Met primary |
| — | NCT00004826 | Oct 1993 → Nov 1997 | Parkinson disease | Memorial Hospital of Rhode Island | Completed | No outcome recorded |
| Comparator or background therapy28 trials | ||||||
| Phase 0 | NCT07533591 Background | May 2026 → Apr 2029 expected | Parkinson disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07085195 Background | Aug → Dec 2025 overdue | Parkinson disease | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06906224 Comparator | May 2022 → Nov 2023 | schizophrenia | Chuanfu Song | Completed | No outcome recorded |
| Phase 1 | NCT07262736 Comparator | Feb 2021 → Feb 2022 | — | Universiti Sains Malaysia | Completed | No outcome recorded |
| Phase 1/2 | NCT00042224 Background | Dec 2000 → Jul 2008 | schizophrenia | Northwell Health | Completed | No outcome recorded |
| Phase 2 | NCT01323205 Background | May 2011 → Nov 2012 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00216281 Comparator | Sep 2005 → Oct 2006 | schizophrenia | Indiana University | Terminated | No outcome recorded |
| Phase 3 | NCT00649844 Comparator | Jan 2003 → Sep 2004 | schizophrenia | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00000372 Background | Mar 1998 → Nov 2005 | schizophrenia | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT06969755 Comparator | Sep 2025 → Jul 2030 expected | schizophrenia | Northwell Health | Recruiting | 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 | NCT04898270 Background | Dec 2019 → Dec 2020 | metabolic syndrome X, schizophrenia | Taichung Veterans General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03807882 Comparator | Feb 2019 → May 2020 | treatment-refractory schizophrenia | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT03772951 Comparator | Jan 2019 → Mar 2021 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT03652974 Background | Sep 2018 → Aug 2021 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT02751307 Comparator | May 2013 → Jan 2015 | metabolic syndrome X | Taipei Medical University WanFang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00981526 Background | Mar 2009 → May 2012 | schizoaffective disorder, schizophrenia | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 4 | NCT01279213 Comparator | Jan → Oct 2009 | schizophrenia | Universidad Nacional de Rosario | Completed | No outcome recorded |
| Phase 4 | NCT01401491 Comparator | Jan 2008 → Dec 2010 | schizophrenia | Taipei Medical University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00654576 Comparator | Feb 2005 → Dec 2007 | schizophrenia | Central South University | Completed | No outcome recorded |
| Phase 4 | NCT00031317 Background | Feb 2002 → Jun 2005 | panic disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT00048828 Comparator | Oct 2001 → Jun 2006 | schizophrenia | Northwell Health | Completed | No outcome recorded |
| Phase 4 | NCT00169065 Comparator | Aug 1998 → Jun 2002 | schizophrenia | Harvard Medical School (HMS and HSDM) | Completed | No outcome recorded |
| Phase 4 | NCT00001656 Comparator | Jun 1997 → Jun 2008 | childhood-onset schizophrenia | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| — | NCT03651674 Comparator | Sep 2018 → Dec 2019 | manic bipolar affective disorder, schizophrenia | Xidian University | Unknown | No outcome recorded |
| — | NCT02926976 Comparator | Nov 2016 → Sep 2019 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT01398189 Background | Jul 2011 → Jul 2015 | schizoaffective disorder, schizophrenia | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| — | NCT00753051 Comparator | Jun 2008 → Mar 2012 | schizophrenia | Khon Kaen University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-05-28 | HLS Therapeutics, Inc | Results New Study Published on the Impact of Pharmaceutical Support Programs on Persistence with Clozapine Treatment hlstherapeutics.com ↗
HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that results from a Quebec-based retrospective study examining the positive impact of pharmaceutical support programs ("PSPs") on persistence with clozapine treatment have been published in the Journal of Clinical Pharmacology and Therapeutics. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-05-28 | HLS Therapeutics, Inc | New Study Published on the Impact of Pharmaceutical Support Programs on Persistence with Clozapine Treatment hlstherapeutics.com ↗ |
| 2015-09-09 | HLS Therapeutics, Inc | HLS Therapeutics Inc. Announces Acquisition of U.S. and Canadian rights to Clozaril® hlstherapeutics.com ↗ |
| 2014-02-11 | Jazz Pharmaceuticals | Jazz Pharmaceuticals Announces U.S. Commercial Availability Of Versacloz™ (clozapine, USP) Oral Suspension jazzpharma.com ↗ |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clozapine | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗68“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil) antidepressants (SSRI, SNRI), mood stabilizers (lithium, depakine), antipsychotics (clozapine and...” NCT06993662 ↗ “After the surgery, combined with clozapine, the abnormal activity of the subthalamic nucleus was precisely intervened to improve the core motor symptoms of Parkinson's disease.” NCT07533591 ↗ “The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet).” NCT00501618 ↗ “Multi-acting receptor-targeted antipsychotics (MARTAs): clozapine, olanzapine, quetiapine.” NCT04898270 ↗ “olanzapine,clozapine,magnesium valproat,etc.” NCT03651674 ↗ |
| Known as | Clozapina | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (caraco) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (clozaril) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (fazaclo) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (ivax) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (mylan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (teva) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (udl) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine (versacloz) | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | CLOZAPINE CHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozapine resolution mixture | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Clozaril | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01654601 ↗ |
| Known as | CLZ | “Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia (SZ).” NCT02404155 ↗ |
| Known as | Fazaclo | “The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet).” NCT00501618 ↗ |
| Known as | Fazaclo odt | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | HF 1854 | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Leponex | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | NSC-757429 | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Versacloz | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Known as | Zaponex | ChEMBL registry synonym — accepted as the source's own label CHEMBL42 ↗ |
| Action | Activate | “Both clozapine and D-cycloserine may improve negative symptoms by activation of the glycine modulatory site of the NMDA receptor complex.” NCT00000372 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL42 ↗1“Dopamine D2 receptor antagonist” CHEMBL42 ↗ |
| Modality | Other / unclassified | “clozapine, an atypical antipsychotic” NCT01639872 ↗ |
| Route | Oral | “The drug is taken orally at night” NCT00004826 ↗ |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL42 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL42 ↗ |