Drugs / Olanzapine
Olanzapine
also known as
Zyprexa · OLZ · OLA · olanzapine long-acting injection · olanzapine LAI · Arkolamyl · IM olanzapine depot · LY170053 · +35 more
Small molecule targets DRD4, HTR2A, HTR2C via inhibition
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed bipolar I disorder 1 milestone | |||||
| Filed | US (FDA) | Zyprexa | bipolar I disorder | — | “FDA will consider the panel's recommendations in its review of the supplemental New Drug Applications that Lilly submitted for Zyprexa.” lilly.com ↗ |
| Filed schizophrenia 4 milestones | |||||
| Filed | EU (EMA) | — | schizophrenia | 2026-05-21 | “today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the...” tevapharm.com ↗ “The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia...” tevapharm.com ↗ “submitted new drug applications to the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) for approval of olanzapine long-acting injection” lilly.com ↗ “In May 2026, the EMA accepted the MAA for olanzapine LAI (TEV-’749).” tevapharm.com ↗ |
| Filed | US (FDA) | Zyprexa | schizophrenia | 2025-12-09 | “submitted new drug applications to the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) for approval of olanzapine long-acting injection” lilly.com ↗ “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749)” tevapharm.com ↗ “FDA will consider the panel's recommendations in its review of the supplemental New Drug Applications that Lilly submitted for Zyprexa.” lilly.com ↗ “olanzapine LAI New Drug Application (NDA) accepted by the FDA in February 2026 for once-monthly treatment of schizophrenia in adults” tevapharm.com ↗ |
| Rejected (CRL) | US (FDA) | — | schizophrenia | 2009-01-07 | “complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults” lilly.com ↗ |
| Rejected (CRL) | US (FDA) | Zyprexa | schizophrenia | 2008-02-28 | “a not approvable letter from the U.S. Food and Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia” lilly.com ↗ “The company received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for Zyprexa long-acting injection” lilly.com ↗ “The company submitted a reply to the FDA regarding the agency's complete response letter for Zyprexa long-acting injection.” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | ZYPREXA | — | 2000-03-17 – 2013-07-26 | fda.gov ↗ |
| Approved | US (FDA) | ZYPREXA | — | 1996-09-30 | fda.gov ↗ |
| Approved | EU (EMA) | Zyprexa | — | 1996-09-27 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03790085 | Sep 2018 → Jun 2020 | anxiety disorder, major depressive disorder, schizophrenia | Tianjin Medical University General Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT02708394 | Feb 2017 → Oct 2023 | — | Wayne State University | Completed | No outcome recorded |
| Phase 120 trials | ||||||
| Phase 1 | NCT06319170 | Mar 2024 → Jan 2025 | schizophrenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06253546 | Mar 2024 → Jun 2025 | schizophrenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06107803 | Oct 2023 → Jan 2024 | schizophrenia | Minerva Neurosciences | Completed | No outcome recorded |
| Phase 1 | NCT05547100 | Sep → Nov 2022 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04987658 | Jul 2021 → Aug 2023 | bipolar I disorder | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03741478 | Oct 2019 → Jul 2026 overdue | — | Centre for Addiction and Mental Health | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03624322 | Aug → Oct 2018 | — | Impel Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03781115 | Nov 2017 → Feb 2027 expected | schizophrenia | University of Arizona | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02804568 | Jun → Aug 2016 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02087579 | Feb → Oct 2014 | bipolar disorder, depressive disorder, schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02051387 | Jan 2013 → Aug 2017 | schizophrenia | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| Phase 1 | NCT01607762 | Feb → Apr 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00852956 | Feb → Apr 2009 | — | OBEcure Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00489593 | Oct 2006 → Dec 2013 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00150215 | Jul → Oct 2005 | schizophrenia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00647777 | Jun → Jul 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648921 | Jun → Jul 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00647972 | May 2003 | — | Mylan Pharmaceuticals Inc | Terminated | No outcome recorded |
| Phase 1 | NCT00255879 | Jan 1999 → Aug 2004 | drug-induced dyskinesia | University of California, San Diego | Completed | No outcome recorded |
| Phase 1 | NCT00094640 | — | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT05814640 | Feb 2023 → Dec 2026 expected | major depressive disorder, splenic sequestration | First Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02650102 | Jan 2013 → Dec 2016 | schizophrenia | Shanxi Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT00446992 | Apr 2006 → Mar 2010 | schizophrenia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 1/2 | NCT00485810 | Jun → Nov 2004 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01282632 | Aug 2002 → Mar 2004 | major depressive disorder | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 1/2 | NCT00089869 | — | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 235 trials · 1 met primary | ||||||
| Phase 2 | NCT07152184 | Oct 2026 → Feb 2032 expected | schizophrenia | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07841210 | Sep 2026 → Jan 2028 expected | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07581405 | Jul 2026 → Jul 2028 expected | gastric adenocarcinoma | University of Illinois at Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07455955 | Mar 2026 → Jun 2027 expected | breast cancer | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT06995508 | Dec 2025 → Nov 2030 expected | head and neck squamous cell carcinoma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05705492 | Jul 2024 → Jun 2027 expected | biliary tract cancer, carcinoma of esophagus, colorectal carcinoma, gastric carcinoma +2 | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06554613 | Jul 2024 → Dec 2026 expected | non-small cell lung carcinoma | Second Affiliated Hospital of Nanchang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06065722 | Sep → Dec 2023 | chemotherapy-induced toxicity | Simon Williamson Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT05676294 | Jun 2023 → Dec 2025 | — | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT05179772 | Jul 2022 → Jan 2023 | substance-related disorder | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 2 | NCT05163717 | Jun 2022 → Mar 2023 | developmental delay, behavioral abnormalities, and neuropsychiatric disorders | Impel Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT05170919 | Jan 2022 → Dec 2026 expected | anorexia nervosa | Englewood Hospital and Medical Center | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT04750395 | Sep 2021 → May 2024 | delirium | HCA Hospice Care | Unknown | No outcome recorded |
| Phase 2 | NCT04669132 | Dec 2020 → Dec 2021 | chemotherapy-induced toxicity | Instituto Brasileiro de Controle do Cancer | Completed | No outcome recorded |
| Phase 2 | NCT05202275 | Dec 2020 → Dec 2022 | head and neck squamous cell carcinoma | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT04518319 | Oct 2020 → Nov 2024 | schizophrenia | Shanghai Mental Health Center | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03679182 | Sep 2018 → Sep 2020 | — | Khon Kaen University | Unknown | No outcome recorded |
| Phase 2 | NCT03575637 | Jul 2018 → May 2021 | gastric cancer | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT03478605 | May 2018 → May 2019 | chemotherapy-induced toxicity | Blokhin's Russian Cancer Research Center | Unknown | No outcome recorded |
| Phase 2 | NCT02755116 | Apr 2016 → Sep 2019 | — | Jaime B Hyman | Completed | Met primary |
| Phase 2 | NCT02462473 | May 2015 → Jan 2016 | schizoaffective disorder, schizophrenia | Janssen Research & Development, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02400866 | May → Nov 2015 | cancer | Korean South West Oncology Group | Unknown | No outcome recorded |
| Phase 2 | NCT02290470 | Apr 2014 → Nov 2015 | — | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | No outcome recorded |
| Phase 2 | NCT02129478 | Mar 2014 → Jan 2016 | chemotherapy-induced toxicity | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 2 | NCT02097823 | Feb 2014 → Feb 2015 | chemotherapy-induced toxicity | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT01148264 | Jul 2010 → Oct 2013 | — | Karin Jordan | Terminated | No outcome recorded |
| Phase 2 | NCT00686998 | May 2008 → Mar 2009 | schizophrenia | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00678457 | Jan 2007 → May 2008 | alcohol dependence | University of Virginia | Completed | No outcome recorded |
| Phase 2 | NCT00316238 | Apr 2006 → May 2007 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00265551 | Jan 2006 → Jan 2007 | schizophrenia | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Mixed |
| Phase 2 | NCT00692185 | Oct 2005 → Sep 2010 | eating disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00259870 | Sep 2005 → Aug 2007 | schizophrenia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00073164 | Jul 2003 → ? | schizophrenia | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT00057408 | May 2003 → Sep 2005 | autism | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 2 | NCT00260962 | Sep 2000 → Jul 2006 | anorexia nervosa | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2/36 trials · 1 met primary | ||||||
| Phase 2/3 | NCT06175273 | Jan 2024 → Aug 2025 | childhood malignant neoplasm, muscular atrophy, nutritional deficiency disease | Corey Hawes | Completed | No outcome recorded |
| Phase 2/3 | NCT04181385 | Jan 2019 → Jan 2020 | — | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2/3 | NCT03631004 | Oct 2018 → Feb 2021 | — | Cancer Institute of the State of São Paulo | Completed | No outcome recorded |
| Phase 2/3 | NCT03137121 | Jul 2017 → Jul 2019 | cancer of unknown primary site | University of Alabama at Birmingham | Completed | Met primary |
| Phase 2/3 | NCT00876772 | Mar 2011 → Jul 2012 | amyotrophic lateral sclerosis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2/3 | NCT00183404 | Sep 2004 → Jul 2011 | autism | Drexel University | Completed | No outcome recorded |
| Phase 376 trials · 14 met primary · 7 missed | ||||||
| Phase 3 | NCT07565428 | Apr 2026 → Dec 2027 expected | — | Minerva Neurosciences | Recruiting | No outcome recorded |
| Phase 3 | NCT07413809 | Oct 2025 → Sep 2027 expected | plasma cell myeloma | The Affiliated People's Hospital of Ningbo University | Recruiting | No outcome recorded |
| Phase 3 | NCT07035821 | Jul 2025 → Jun 2026 overdue | chemotherapy-induced toxicity, childhood malignant neoplasm | Shanghai Children's Medical Center | Not yet recruiting | Met primary |
| Phase 3 | NCT07633236 | Mar 2025 → Dec 2026 expected | chemotherapy-induced toxicity | Blokhin's Russian Cancer Research Center | Recruiting | No outcome recorded |
| Phase 3 | NCT06850454 | Jan 2025 → Jan 2026 overdue | chemotherapy-induced toxicity | Mahidol University | Recruiting | No outcome recorded |
| Phase 3 | NCT06588413 | Sep 2024 → Oct 2027 expected | disease related to hematopoietic stem cell transplant, plasma cell myeloma | Augusta University | Recruiting | No outcome recorded |
| Phase 3 | NCT06500234 | Jun 2024 → May 2025 overdue | cancer, nutritional disorder | Qingdao Central Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06200181 | Apr 2024 → Nov 2026 expected | opioid abuse | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06338683 | Mar 2024 → Mar 2027 expected | — | Qinghai Red Cross Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05895838 | Jun 2023 → Sep 2027 expected | cardiac arrest, post-cardiac arrest syndrome | Christian Hassager | Recruiting | No outcome recorded |
| Phase 3 | NCT05803642 | Mar 2023 → May 2024 | — | Qilu Pharmaceutical Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT05403580 | Jun 2022 → Dec 2023 | cancer, hematopoietic and lymphoid cell neoplasm | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05346731 | Apr 2022 → Mar 2024 | chemotherapy-induced toxicity | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 3 | NCT05244577 | Jan 2022 → Dec 2023 | malignant testicular germ cell tumor | Shi Yanxia | Unknown | No outcome recorded |
| Phase 3 | NCT04939090 | Jan 2022 → Apr 2027 expected | cancer, hematopoietic and lymphoid cell neoplasm | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04987229 | Oct 2021 → Sep 2027 expected | bipolar I disorder, schizophrenia | Alkermes, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04503668 | Dec 2020 → Jan 2024 | female reproductive organ cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT04536558 | Oct 2020 → Feb 2021 | chemotherapy-induced toxicity | Sun Yat-sen University | Unknown | Met primary |
| Phase 3 | NCT04535141 | Aug 2020 → Apr 2022 | chemotherapy-induced toxicity | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT04232423 | Mar 2020 → Jun 2021 | — | Department of Medical Services Ministry of Public Health of Thailand | Completed | No outcome recorded |
| Phase 3 | NCT04437017 | Feb 2020 → May 2022 | chemotherapy-induced toxicity | Fifth Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 3 | NCT04075955 | Apr → Dec 2019 | chemotherapy-induced toxicity | CR-CSSS Champlain-Charles-Le Moyne | Completed | No outcome recorded |
| Phase 3 | NCT03876938 | Mar 2019 → Aug 2020 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 3 | NCT03510325 | Feb 2019 → Sep 2023 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 3 | NCT03578081 | Nov 2018 → Nov 2021 | cancer | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| Phase 3 | NCT03367572 | Apr 2018 → Apr 2024 | breast carcinoma | University of Rochester NCORP Research Base | Completed | No outcome recorded |
| Phase 3 | NCT02939287 | Sep 2017 → Dec 2021 | — | Rush University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03219710 | Jul 2017 → Jul 2019 | chemotherapy-induced toxicity | All India Institute of Medical Sciences | Completed | Met primary |
| Phase 3 | NCT03201757 | Jun 2017 → Sep 2023 | bipolar I disorder, schizophrenia, schizophreniform disorder | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03079219 | Mar 2017 → Mar 2021 | breast cancer | CCTU | Completed | No outcome recorded |
| Phase 3 | NCT02873208 | Aug 2016 → Oct 2019 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02717195 | Apr 2016 → Aug 2018 | schizophrenia | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT02634346 | Dec 2015 → May 2017 | schizophrenia | Alkermes, Inc. | Completed | Met primary |
| Phase 3 | NCT02484911 | May 2015 → Sep 2016 | chemotherapy-induced toxicity | First Affiliated Hospital of Harbin Medical University | Completed | Missed primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02116530 | Aug 2014 → Apr 2015 | cancer of unknown primary site, hematopoietic and lymphoid cell neoplasm | Alliance for Clinical Trials in Oncology | 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 | NCT01687478 | Sep 2012 → Nov 2015 | — | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 3 | NCT01184443 | Aug 2010 → Aug 2013 | eating disorder | Children's Hospital of Eastern Ontario | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00970281 | Sep 2009 → Apr 2011 | schizophrenia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00958568 | Aug 2009 → Mar 2012 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00632645 | Apr 2009 → Apr 2017 | Huntington disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00640510 | Mar → Jul 2008 | schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00618748 | Feb 2008 → Sep 2010 | bipolar I disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00510146 | Aug 2007 → Mar 2010 | bipolar depression | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00440843 | Feb 2007 → Jun 2012 | schizoaffective disorder, schizophrenia | VA Connecticut Healthcare System | Withdrawn | No outcome recorded |
| Phase 3 | NCT00347425 | Dec 2006 → Feb 2008 | schizophrenia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00401973 | Nov 2006 → Sep 2008 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00797277 | Jul 2006 → Jun 2009 | schizoaffective disorder, schizophrenia | National Taiwan University Hospital | Completed | Met primary |
| Phase 3 | NCT00380224 | Jul 2006 → Sep 2007 | schizophrenia | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00350467 | Jun 2006 → Sep 2007 | schizophrenia | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00320489 | Apr 2006 → Sep 2009 | schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00266630 | Nov 2005 → May 2009 | manic bipolar affective disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00259272 | Nov 2005 → May 2008 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00455234 | Sep 2005 → Jul 2006 | psychotic disorder | Christian Medical College, Vellore, India | Completed | No outcome recorded |
| Phase 3 | NCT00129220 | Jul 2005 → Jan 2009 | bipolar I disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00273624 | Jun 2005 → Dec 2009 | major depressive disorder | University Hospital Freiburg | Withdrawn | No outcome recorded |
| Phase 3 | NCT00113594 | Jun 2005 → Mar 2006 | bipolar disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00124930 | May 2005 → Jun 2008 | cancer or benign tumor | Alberta Health services | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00088465 | Aug 2004 → Dec 2010 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00485901 | Jul 2004 → Jan 2005 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00088491 | Jun 2004 → Oct 2006 | schizophrenia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00088478 | Jun 2004 → Apr 2005 | schizophrenia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00091650 | Mar 2004 → Nov 2005 | borderline personality disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00088036 | Feb 2004 → Jan 2006 | borderline personality disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00485680 | Dec 2003 → Jun 2005 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00145444 | Mar 2003 → Nov 2005 | schizophrenia | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01977300 | Jan 2003 → Aug 2011 | bipolar I disorder | University of British Columbia | Completed | No outcome recorded |
| Phase 3 | NCT00051298 | Nov 2002 → Apr 2005 | schizophrenia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00746785 | Sep 2002 → May 2010 | alcohol dependence | The Mind Research Network | Completed | No outcome recorded |
| Phase 3 | NCT00194064 | Jul 2002 → Feb 2006 | bipolar disorder | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00035321 | Apr 2002 → Jul 2005 | major depressive disorder | Eli Lilly and Company | Completed | Mixed |
| Phase 3 | NCT00034892 | Mar 2002 → Mar 2005 | schizophrenia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00159770 | Nov 2001 → Sep 2004 | schizoaffective disorder, schizophrenia | Viatris Inc. | 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 481 trials · 8 met primary · 9 missed | ||||||
| Phase 4 | NCT07482891 | Mar → Oct 2026 expected | chemotherapy-induced toxicity | Shanghai 6th People's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06740890 | Jun 2025 → Apr 2027 expected | bipolar disorder, schizoaffective disorder, schizophrenia | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06133114 | Mar 2024 → Oct 2026 expected | — | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 4 | NCT06357104 | Feb → Mar 2024 | — | Pachankis, Yang I., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT05590923 | Dec 2022 → Jul 2025 | chemotherapy-induced toxicity | The Guthrie Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04478838 | Jun 2022 → Sep 2027 expected | schizophrenia | Centre for Addiction and Mental Health | Recruiting | No outcome recorded |
| Phase 4 | NCT03571126 | May 2019 → Oct 2022 | chemotherapy-induced toxicity, lung cancer | Zunyi Medical College | Unknown | No outcome recorded |
| Phase 4 | NCT02536846 | Nov 2017 → Nov 2019 | — | Dost Ongur | Completed | No outcome recorded |
| Phase 4 | NCT03246620 | Sep 2017 → Jun 2018 | — | The University of Hong Kong | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03066622 | Jul 2016 → May 2018 | headache disorder | HealthPartners Institute | Completed | No outcome recorded |
| Phase 4 | NCT02435654 | Aug 2015 → Dec 2018 | early-onset schizophrenia | Kunming Medical University | Completed | No outcome recorded |
| Phase 4 | NCT02307396 | Feb 2015 → Jun 2016 | schizoaffective disorder, schizophrenia | Technical University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT02380118 | Dec 2014 → Sep 2019 | — | The University of Hong Kong | Terminated | No outcome recorded |
| Phase 4 | NCT02287259 | Nov 2014 → Mar 2019 | bipolar disorder | Tadashi Hasegawa | Completed | No outcome recorded |
| Phase 4 | NCT01893229 | Sep 2013 → Dec 2015 | bipolar disorder | Guiyun Xu | Unknown | No outcome recorded |
| Phase 4 | NCT02593734 | Jul 2013 → Jul 2015 | anxiety disorder, mood disorder, schizophrenia | University of Ghana Medical School | Completed | No outcome recorded |
| Phase 4 | NCT01920802 | Nov 2012 → Aug 2014 | — | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT02137993 | Mar 2012 → May 2013 | schizoaffective disorder, schizophrenia, schizophreniform disorder | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02704962 | Jan 2012 → Feb 2016 | schizophrenia | Kaohsiung Kai-Suan Psychiatric Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01164059 | Feb 2010 → Aug 2013 | schizophrenia | University of Bremen | Completed | Mixed |
| Phase 4 | NCT00982020 | Sep 2009 → May 2013 | bipolar I disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00844857 | Apr 2009 → Feb 2012 | bipolar depression | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01016145 | Apr 2009 → Jun 2010 | psychotic disorder | University of Sao Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT01411930 | Mar 2009 → Mar 2010 | diabetes mellitus | Veterans Medical Research Foundation | Completed | No outcome recorded |
| Phase 4 | NCT01303601 | Jan 2009 → Oct 2010 | bipolar depression | China Medical University, China | Completed | No outcome recorded |
| Phase 4 | NCT00802100 | Dec 2008 → Sep 2009 | schizophrenia | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT01000402 | Feb 2008 → Oct 2012 | attention deficit-hyperactivity disorder, bipolar disorder | Federal University of Rio Grande do Sul | Unknown | No outcome recorded |
| Phase 4 | NCT00520507 | Oct 2007 → May 2009 | bipolar disorder, depressive disorder | Queen's University | Completed | Missed primary |
| Phase 4 | NCT01149577 | Aug → Dec 2007 | schizophrenia | Central Institute of Psychiatry, Ranchi, India | Completed | No outcome recorded |
| Phase 4 | NCT01052389 | Jul 2007 → Jun 2012 | schizophrenia | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 4 | NCT00384332 | Jan 2007 → Mar 2010 | bipolar depression | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00402324 | Dec 2006 → Feb 2008 | bipolar I disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00433121 | Sep 2006 → Aug 2007 | dementia | Innlandet Hospital Trust | Completed | No outcome recorded |
| Phase 4 | NCT00324051 | May 2006 → Sep 2007 | schizophrenia | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00337662 | May 2006 → Dec 2007 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00303602 | Mar 2006 → Dec 2007 | bipolar disorder, schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00854919 | Jan 2006 → Dec 2007 | — | Osaka City University | Completed | No outcome recorded |
| Phase 4 | NCT00245206 | Aug 2005 → Oct 2010 | Alzheimer disease, schizophrenia | Veterans Medical Research Foundation | Completed | No outcome recorded |
| Phase 4 | NCT00186017 | Jul 2005 → Jun 2010 | bipolar disorder | Stanford University | Completed | Missed primary |
| Phase 4 | NCT00297960 | Apr 2005 → ? | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00767715 | Oct 2004 → Apr 2005 | bipolar disorder | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00094549 | Oct 2004 → Dec 2006 | bipolar disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00191997 | Oct 2004 → Mar 2006 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00190892 | Sep 2004 → Jun 2006 | bipolar disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00103571 | Jul 2004 → Aug 2006 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00090012 | Jul 2004 → Mar 2006 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191399 | May 2004 → Mar 2006 | bipolar depression | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00485771 | Nov 2003 → Jan 2005 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00685334 | Nov 2003 → Sep 2006 | anorexia nervosa | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00182442 | Oct 2003 → Mar 2006 | schizophrenia | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00088049 | Oct 2003 → Jul 2007 | schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00190749 | Oct 2003 → Jun 2008 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00108368 | Oct 2003 → Mar 2006 | schizophrenia | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00208819 | Sep 2003 → Jul 2007 | Alzheimer disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00100776 | Sep 2003 → Nov 2005 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191555 | Aug 2003 → May 2006 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00071253 | Jul 2003 → ? | bipolar disorder | Abbott | Terminated | No outcome recorded |
| Phase 4 | NCT00239109 | Apr 2003 → Feb 2007 | schizophrenia | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00485498 | Apr → Dec 2003 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00926965 | Jan 2003 → Dec 2007 | cognitive disorder, tardive dyskinesia | Taipei Veterans General Hospital, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00050206 | Nov 2002 → May 2005 | bipolar disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00048802 | Aug 2002 → Aug 2006 | bipolar disorder | Northwell Health | Completed | No outcome recorded |
| Phase 4 | NCT00418171 | Feb 2002 → Apr 2007 | schizophrenia | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00202293 | Oct 2001 → Nov 2015 | bipolar disorder, schizoaffective disorder | Melbourne Health | Completed | No outcome recorded |
| Phase 4 | NCT00034801 | Sep 2001 → Mar 2003 | depressive disorder, schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00034580 | Aug 2001 → Aug 2002 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00036088 | Aug 2001 → Jul 2002 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00177567 | Jul 2001 → Jan 2004 | bipolar disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT00182013 | Jun 2001 → Feb 2004 | bipolar disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00181935 | Mar 2001 → Jul 2004 | manic bipolar affective disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00014001 | Dec 2000 → Dec 2004 | schizophrenia | National Institute of Mental Health (NIMH) | Completed | Mixed |
| Phase 4 | NCT00018668 | Oct 2000 → Sep 2004 | schizophrenia | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00331825 | Jul 2000 → Jul 2003 | extrapyramidal and movement disease, schizophrenia | Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00621998 | Jul 2000 → Dec 2003 | tardive dyskinesia | Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan | Completed | Missed primary |
| Phase 4 | NCT00182507 | Jun 2000 → Mar 2006 | trichotillomania | Hamilton Health Sciences Corporation | Completed | Met primary |
| Phase 4 | NCT00592930 | Jun 2000 → Dec 2004 | anorexia nervosa | Northwell Health | Completed | Missed primary |
| Phase 4 | NCT00000374 | Sep 1998 → May 2007 | schizophrenia | Northwell Health | Completed | No outcome recorded |
| Phase 4 | NCT00007774 | Mar 1998 → Jun 2001 | schizoaffective disorder, schizophrenia | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00236379 | ? → Aug 2003 | diabetes mellitus, schizophrenia | Janssen, LP | Completed | No outcome recorded |
| Phase 4 | NCT00221481 | ? → Mar 2006 | bipolar disorder | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00237861 | ? → Dec 2002 | schizophrenia | Yale University | Completed | No outcome recorded |
| Phase not applicable36 trials · 1 met primary · 3 missed | ||||||
| — | NCT07442890 | Apr 2026 → Apr 2028 expected | lung cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06251635 | Jun 2024 → Dec 2026 expected | type 2 diabetes mellitus | Centre for Addiction and Mental Health | Active not recruiting | No outcome recorded |
| — | NCT05635227 | Nov 2022 → Dec 2027 expected | aortic valve disorder, coronary artery disorder | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| — | NCT06200584 | Jan → Jun 2021 | poisoning | Dr Rabia Arshad | Completed | No outcome recorded |
| — | NCT04478526 | Apr 2020 → May 2021 | generalized anxiety disorder | Dr. Nazanin Alavi | Completed | No outcome recorded |
| — | NCT04218981 | Jan 2020 → Jun 2023 | mental disorder | Central South University | Completed | No outcome recorded |
| — | NCT02970643 | Jul 2016 → Sep 2017 | chemotherapy-induced toxicity | Hee Jun Kim | Unknown | No outcome recorded |
| — | NCT02643355 | Nov 2015 → Jun 2017 | substance withdrawal syndrome | Hennepin Healthcare Research Institute | Completed | No outcome recorded |
| — | NCT01625923 | Jan 2013 → Jun 2019 | idiopathic gastroparesis | University of Michigan | Terminated | Missed primary Stop: Enrollment |
| — | NCT04076371 | Jan 2012 → Dec 2018 | schizophrenia | Beijing HuiLongGuan Hospital | Completed | No outcome recorded |
| — | NCT01389908 | Jun 2011 → Jul 2014 | schizoaffective disorder, schizophrenia | Shalvata Mental Health Center | Unknown | No outcome recorded |
| — | NCT03019887 | Apr 2011 → Jan 2017 | schizophrenia | Juntendo University | Completed | No outcome recorded |
| — | NCT01170117 | Aug 2010 → Jun 2016 | anorexia nervosa | New York State Psychiatric Institute | Completed | Mixed |
| — | NCT01539733 | Mar 2010 → Apr 2017 | cancer of unknown primary site, delirium | Amsterdam UMC, location VUmc | Completed | Missed primary |
| — | NCT00716755 | Oct 2009 → Aug 2015 | delusional disorder, schizoaffective disorder, schizophrenia, schizophreniform disorder | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| — | NCT01057849 | Sep 2008 → Mar 2011 | schizophrenia | Peking University | Unknown | No outcome recorded |
| — | NCT00737191 | Aug 2008 → Nov 2009 | cancer of unknown primary site, hematopoietic and lymphoid system neoplasm | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00741026 | Aug 2008 → Dec 2010 | diabetes mellitus | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT01496183 | Oct 2007 → Apr 2013 | — | State University of New York at Buffalo | Completed | No outcome recorded |
| — | NCT00512070 | Jul 2007 → Dec 2010 | bipolar disorder, metabolic syndrome X, obesity disorder, schizoaffective disorder +1 | Seattle Institute for Biomedical and Clinical Research | Completed | No outcome recorded |
| — | NCT00493233 | Nov 2006 → Dec 2008 | schizophrenia | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| — | NCT00534183 | Jun → Dec 2006 | diabetes mellitus, metabolic syndrome X, obesity disorder | Central Institute of Psychiatry, Ranchi, India | Completed | No outcome recorded |
| — | NCT00275301 | Dec 2005 → Apr 2008 | borderline personality disorder | University of Minnesota | Completed | No outcome recorded |
| — | NCT00512291 | Jun 2005 → Aug 2007 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT01160991 | May 2004 → Oct 2006 | diabetes mellitus, schizophrenia | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| — | NCT00203307 | May 2004 → Mar 2006 | migraine disorder | Thomas Jefferson University | Terminated | No outcome recorded |
| — | NCT00222495 | Aug 2002 → Aug 2006 | schizoaffective disorder, schizophrenia, schizophreniform disorder | University of Minnesota | Completed | No outcome recorded |
| — | NCT00225498 | Jun 2002 → Oct 2008 | schizophrenia | Northwell Health | Completed | No outcome recorded |
| — | NCT01234454 | Jan 2002 → Jun 2005 | schizophrenia | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT00015548 | Mar 2001 → Oct 2004 | Alzheimer disease | National Institute of Mental Health (NIMH) | Completed | Missed primary |
| — | NCT00205725 | Nov 2000 → Oct 2006 | schizophrenia, type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00205738 | Jul 2000 → Oct 2006 | schizophrenia, type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00179231 | May 2000 → Feb 2004 | schizoaffective disorder, schizophrenia | Vanderbilt University | Completed | No outcome recorded |
| — | NCT00183612 | May 2000 → Apr 2007 | bipolar disorder, psychotic disorder | Massachusetts General Hospital | Terminated | No outcome recorded |
| — | NCT01123408 | Jun 1999 → Jul 2004 | schizophrenia | Nathan Kline Institute for Psychiatric Research | Completed | Met primary |
| — | NCT00006195 | — | schizophrenia | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Comparator or background therapy164 trials | ||||||
| Phase 0 | NCT07662200 Background | Aug 2026 → Aug 2027 expected | malignant germ cell tumor | Ottawa Hospital Research Institute | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06315283 Comparator | Mar 2024 → Aug 2025 | schizophrenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05964647 Comparator | Feb 2024 → Jun 2025 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 1 | NCT06600477 Comparator | Oct → Nov 2023 | — | Neurelis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT07190482 Comparator | Oct 2023 → Dec 2024 | tinnitus | University of Sao Paulo | Completed | No outcome recorded |
| Show all 164 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces U.S. Food and Drug Administration (FDA) Approval of WELTRUZA™ (Olanzapine) For Extended-Release Injectable Suspension, as the First and Only Once-Monthly Subcutaneous Injectable Olanzapine for Adults with Schizophrenia tevapharm.com ↗ |
| 2026-09-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces New Olanzapine LAI (TEV-'749) Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of new olanzapine LAI (TEV-'749) post hoc data from the pivotal SOLARIS Phase 3 trial as well as analyses supporting treatment switch strategies. |
| 2026-05-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in Adults tevapharm.com ↗ |
| 2026-05-21 | Alkermes, Inc. | Results Alkermes Showcases Data From Psychiatry Portfolio and Sleep Research into Real World Patient Experience at Spring 2026 Scientific Conferences alkermes.com ↗
Real-World Evidence of Positive Impact of LYBALVI® (olanzapine and samidorphan) on Treatment Patterns and Rates of Relapse Among Patients with Schizophrenia or Bipolar I Disorder, Including Young Adults |
| 2026-04-14 | Alkermes, Inc. | Results Findings From Long-Term Analysis of the Effects of LYBALVI® (olanzapine and samidorphan) on Negative Symptoms of Schizophrenia Published in The Journal of Clinical Psychiatry alkermes.com ↗
The analysis—titled “The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia”—found that treatment with LYBALVI was associated with improvement in mean negative symptom scores. |
| 2026-03-25 | Minerva Neurosciences | Results Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating Roluperidone Co-administered with Olanzapine at SIRS 2026 minervaneurosciences.com ↗
The trial shows no clinically significant adverse effects, no meaningful pharmacokinetic (PK) changes, and no pharmacodynamic (PD) changes during combined administration. |
| 2026-02-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults tevapharm.com ↗ |
| 2025-12-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. |
| 2025-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed tevapharm.com ↗
Through Week 56 in the SOLARIS trial, there were no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events observed with olanzapine LAI (TEV-'749) and its long-term systemic safety profile was consistent with other olanzapine formulations |
| 2025-05-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Latest Schizophrenia Portfolio Data Including Real-World Outcomes with UZEDY® (risperidone) Showing Lower Rates of and Longer Time to Relapse Compared to Oral Treatment Options and New Phase 3 SOLARIS Data Showing No Incidence of PDSS with TEV-'749 (olanzapine) to Date tevapharm.com ↗
Additionally, Phase 3 SOLARIS data show no incidence of post-injection delirium/sedation syndrome (PDSS) to date in participants taking TEV-'749, a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine. |
| 2025-03-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable tevapharm.com ↗
More than 92% of patients, 87% of nurses and 72% of physicians were either satisfied or very satisfied when asked about TEV-'749, overall, including initiation regimen, monthly dosing schedule and dosing options. |
| 2024-11-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results Demonstrating Improvements in Social Functioning and Quality of Life in Adults Receiving TEV-'749 (olanzapine) a Subcutaneous Long-Acting Injectable as well as Results of Real-World Analyses of UZEDY® (risperidone) tevapharm.com ↗
In the acute treatment phase of the study (Period 1), TEV-'749 demonstrated significant improvement in social functioning and quality of life across multiple validated measures from baseline to week 8. |
| 2024-09-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable for Adult Patients Diagnosed with Schizophrenia tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. |
| 2024-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Strong Growth in Second Quarter Revenues mainly driven by Generics Products in All Regions and AUSTEDO®; Raises 2024 Financial Guidance tevapharm.com ↗
Announced positive Phase 3 efficacy results for olanzapine LAI (TEV' 749); so far completed ~95% of target injections with no PDSS observed. |
| 2024-05-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia tevapharm.com ↗
Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo. |
| 2024-05-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Reports First Quarter 2024 Financial Results and Reaffirms 2024 Financial Outlook tevapharm.com ↗
Announced positive Phase 3 efficacy results for olanzapine LAI (TEV' 749); no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date. |
| 2024-04-08 | Alkermes, Inc. | Results Alkermes Presents Analyses From Long-Term Safety Study of LYBALVI® (olanzapine and samidorphan) at 2024 Congress of the Schizophrenia International Research Society alkermes.com ↗
Analyses were presented from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients who received up to four years of treatment. |
| 2024-01-03 | Alkermes, Inc. | Results Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI® (olanzapine and samidorphan) alkermes.com ↗
Patients' symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment with LYBALVI, as measured by the Clinical Global Impression of Severity (CGI-S) scale (mean change from baseline in CGI-S score of -0.28). |
| 2023-03-23 | Alkermes, Inc. | Results Journal of Clinical Psychiatry Publishes Data from Alkermes' ENLIGHTEN-Early Study of LYBALVI® (olanzapine and samidorphan) in Young Adults Early in Their Illness alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced the publication of results from its phase 3 ENLIGHTEN-Early study of LYBALVI® (olanzapine and samidorphan) in the peer-reviewed publication, the Journal of Clinical Psychiatry. |
| 2023-03-11 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg (USRLD: Zyprexa Zydis Orally Disintegrating Tablets). |
| 2022-04-07 | Alkermes, Inc. | Results Alkermes Presents New Data From Psychiatry Portfolio at 2022 Congress of the Schizophrenia International Research Society alkermes.com ↗
Detailed Results Presented From ENLIGHTEN-Early Phase 3b Study of LYBALVI® in Patients Early in Illness |
| 2022-02-08 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From ENLIGHTEN-Early Phase 3b Study of LYBALVI® in Patients Early in Illness alkermes.com ↗
LYBALVI Demonstrated Less Weight Gain Compared to Olanzapine in Patients With Schizophrenia, Schizophreniform Disorder or Bipolar I Disorder |
| 2021-06-01 | Alkermes, Inc. | Regulatory Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder alkermes.com ↗ |
| 2021-04-20 | Alkermes, Inc. | Results Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society alkermes.com ↗
New findings from post hoc analyses assessing the effects of olanzapine/samidorphan compared to olanzapine across multiple cardiometabolic risk factors, including blood pressure, BMI and metabolic syndrome. |
| 2020-08-17 | Alkermes, Inc. | Results American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia alkermes.com ↗
DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry. |
| 2020-06-30 | Impel Pharmaceuticals | Results IMPEL NEUROPHARMA ANNOUNCES PUBLICATION OF POSITIVE RESULTS OF SNAP 101 STUDY FOR INP105 FOR THE TREATMENT OF ACUTE AGITATION IN THE JOURNAL OF CLINICAL PSYCHIATRY impelpharma.com ↗
The published results from the study, which can be found here, demonstrated that INP105 reached peak plasma levels (Tmax) approximately twice as fast as intramuscular olanzapine (Zyprexa®), and ten-times faster than orally-disintegrating tablets (ODT, Zyprexa Zydis®). |
| 2020-05-14 | Alkermes, Inc. | Results Alkermes Presents New Data From Schizophrenia Portfolio at Virtual 2020 Congress of the Schizophrenia International Research Society alkermes.com ↗
Results relating to overall safety, tolerability, changes in weight, waist circumference and metabolic parameters are included. |
| 2020-01-28 | Alkermes, Inc. | Regulatory Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder alkermes.com ↗ |
| 2019-12-18 | Starton Therapeutics, Inc | Results ChemioCare Completes Successful Human Bioavailability Study for Novel 7-Day Olanzapine Transdermal Delivery System startontx.com ↗
Olanzapine plasma concentrations observed were within the target range for therapeutic efficacy. |
| 2019-01-06 | Impel Pharmaceuticals | Results Impel Neuropharma Announces Positive Phase 1 Trial For INP105 For The Treatment Of Acute Agitation In Bipolar I Disorder And Schizophrenia impelpharma.com ↗
Results demonstrated that INP105 reached peak plasma levels (Tmax) twice as fast as intramuscular olanzapine (Zyprexa®), and ten-times faster than orally-disintegrating tablets (ODT, Zyprexa Zydis®). |
| 2018-07-18 | Zydus Lifesciences Limited | Regulatory Zydus receives four consecutive ANDA approvals from the USFDA zyduslife.com ↗
Zydus Cadila announced that it has received four consecutive final approvals from the USFDA to market Olanzapine Tablets USP, Glipizide Extended -Release Tablets, Voriconazole for Injection and Fluocinonide Topical Solution USP. |
| 2018-04-04 | Upsher-Smith Laboratories | Regulatory MHLW Approves New Indication for OLANZAPINE Formulation and New Administration for MEROPENEM Formulation upsher-smith.com ↗
This approval expands the indication of OLANZAPINE Tablets 2.5mg “SAWAI”, 5mg “SAWAI”, 10mg “SAWAI”, Fine Granules 1% “SAWAI” to include the same uses as their brand equivalents. |
| 2017-06-29 | Alkermes, Inc. | Results Alkermes Announces Positive Preliminary Topline Results From Phase 3 Antipsychotic Efficacy Study of ALKS 3831 for Treatment of Schizophrenia alkermes.com ↗
Data from the study also showed that olanzapine achieved similar improvements from baseline PANSS scores, compared to placebo (p=0.004). |
| 2012-04-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Zyprexa® tablets sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) for generic version of Zyprexa®, Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg. |
| 2012-02-29 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Zyprexa Zydis® tablets sunpharma.com ↗ |
| 2010-11-16 | Alkermes, Inc. | Results Alkermes Presents Promising Preclinical Data on ALKS 33 for Multiple Disease Indications at Annual Meeting of the Society for Neuroscience alkermes.com ↗
Results showed that ALKS 33 was effective in preventing olanzapine-induced weight gain while not inhibiting olanzapine's antipsychotic activity. |
| 2009-12-14 | Eli Lilly and Company | Regulatory FDA Approves Lilly's ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults lilly.com ↗
The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2009-12-04 | Eli Lilly and Company | Regulatory FDA Approves Lilly's Zyprexa for Two Adolescent Indications lilly.com ↗
The U.S. Food and Drug Administration (FDA) today approved Zyprexa(R) (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old. |
| 2009-06-10 | Eli Lilly and Company | Regulatory FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications lilly.com ↗
For the proposed indication for manic or mixed episodes associated with bipolar I disorder, the panel voted 17-0, with one abstention, that Zyprexa's effectiveness had been demonstrated, and voted 11-4, with three abstentions, that these data demonstrated acceptable safety. |
| 2009-05-18 | Eli Lilly and Company | Results Olanzapine Long-Acting Injection (LAI) Efficacy and Safety Data Presented at American Psychiatric Association Annual Meeting lilly.com ↗
Results from a 190-week interim analysis of a six-year, ongoing, open-label study (HGKB), showed that adults with schizophrenia or schizoaffective disorder treated with olanzapine LAI had a discontinuation rate of 46.3 percent. |
| 2009-03-29 | Eli Lilly and Company | Results Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research lilly.com ↗
Similarly, olanzapine at 15mg once daily also did not separate from placebo. |
| 2009-03-23 | Eli Lilly and Company | Regulatory FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax(R) (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company (NYSE: LLY) announced today. |
| 2009-01-07 | Eli Lilly and Company | Regulatory FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. |
| 2008-09-26 | Eli Lilly and Company | Regulatory Zypadhera(TM) Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Maintenance Treatment of Schizophrenia lilly.com ↗ |
| 2008-09-26 | Eli Lilly and Company | Regulatory CHMP Recommends Approval of Olanzapine Long-acting Injection for Maintenance Treatment of Schizophrenia in Europe lilly.com ↗
The CHMP's positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. |
| 2008-09-02 | Eli Lilly and Company | Results Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months lilly.com ↗
Final results from a 24-week study presented today at a major medical meeting in Barcelona suggest that investigational olanzapine long-acting injection (LAI) therapeutic doses showed a maintenance of treatment benefit for up to six months. |
| 2008-06-23 | Eli Lilly and Company | Results Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference lilly.com ↗
Results from olanzapine long-acting injection (LAI) clinical trials showed that the efficacy and safety profile of olanzapine LAI was generally consistent with that of Zyprexa(R) (olanzapine) with the exception of injection-related events. |
| 2008-02-28 | Eli Lilly and Company | Regulatory FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced today. |
| 2008-02-06 | Eli Lilly and Company | Regulatory FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment lilly.com ↗
The U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee voted that, with appropriate labeling around excessive sedation events, Zyprexa(R) long-acting injection (olanzapine LAI) has been shown to be effective and acceptably safe for the treatment and maintenance treatment of schizophrenia in adults, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2007-10-05 | Eli Lilly and Company | Regulatory Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels lilly.com ↗
Eli Lilly and Company announced today that as a part of on-going discussions with the U.S. Food and Drug Administration (FDA), the company has updated the Zyprexa(R) (olanzapine) and Symbyax(R) (olanzapine and fluoxetine HCl) U.S. product labels. |
| 2007-09-02 | Eli Lilly and Company | Results Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds lilly.com ↗
The study demonstrated that: -- LY2140023 and olanzapine showed statistically significant improvement versus placebo in PANSS (Positive and Negative Syndrome Scale), the most common scale used for measuring symptoms of patients with schizophrenia. |
| 2006-12-01 | Eli Lilly and Company | Results Lilly Responds to the Cost-Effectiveness Analysis of the CATIE Schizophrenia Trial lilly.com ↗
Among the atypicals studied Zyprexa was found to be the most cost-effective. |
| 2006-05-23 | Eli Lilly and Company | Results New Study Suggests Symbyax(R) Significantly Improves Symptoms of Treatment-Resistant Depression lilly.com ↗
The results of a pooled analysis of two new parallel, randomized, double-blind studies suggest that Symbyax(R) (olanzapine and fluoxetine HCl capsules) significantly improved symptoms of treatment-resistant depression (TRD) when compared to either drug alone during a two-month period, based on the Montgomery-Asberg Depression Rating Scale (MADRS). |
| 2006-05-22 | Eli Lilly and Company | Results First Head-to-Head Study Suggests Significantly Greater Symptom Improvement for Symbyax® Compared to Lamotrigine in Bipolar Depression lilly.com ↗
The results were presented today at a major medical meeting. |
| 2006-04-01 | Eli Lilly and Company | Results CATIE Phase 2 Data Confirm Patients Stay on Treatment Longer Because of Symptom Improvement More So Than Tolerability lilly.com ↗
In addition, a secondary analysis in the tolerability arm of the study showed a statistically significant reduction in positive psychotic symptoms (such as paranoid ideas or hearing voices) for patients taking Zyprexa. |
| 2005-12-20 | Eli Lilly and Company | Results New Study Showed No Difference in Total Treatment Costs When Comparing Those Starting Treatment with Older Conventional Antipsychotics and Those Starting Treatment with Zyprexa(R), an Atypical Antipsychotic, in the Treatment of Schizophrenia lilly.com ↗
The data showed that despite higher medication costs of Zyprexa, the difference in one-year direct total costs between Zyprexa, as initial (first-line) treatment, and conventional antipsychotics as first line treatment, was small and not statistically significant. |
| 2005-09-19 | Eli Lilly and Company | Results According to CATIE, Zyprexa(R) More Effective on Discontinuation Rate than Other Antipsychotics Studied lilly.com ↗
CATIE found that for Zyprexa the average time to discontinuation was 9.2 months as compared with 4.6 months for quetiapine, 4.8 months for risperidone, 3.5 months for ziprasidone and 5.6 months for perphenazine. |
| 2005-05-24 | Eli Lilly and Company | Results First Head-to-Head Study Shows Patients with Bipolar Depression Had Greater Symptom Improvement on Olanzapine and Fluoxetine HCl Capsules than Lamotrigine lilly.com ↗
Additionally, results show that patients treated with OFC responded more quickly to therapy than patients treated with lamotrigine. |
| 2005-05-23 | Eli Lilly and Company | Results New Study Showed Efficacy was Most Important Factor in Decision to Stay on Antipsychotic Treatment for Schizophrenia lilly.com ↗
Findings also revealed that patients taking olanzapine were significantly more likely to remain on medication longer than patients taking other atypical and conventional antipsychotics. |
| 2005-04-06 | Eli Lilly and Company | Results Studies Show Schizophrenia Patients Taking Atypicals Stayed on Treatment Longer Than Patients Taking Older, Typical Antipsychotics lilly.com ↗
One of the studies revealed that patients taking olanzapine or clozapine remained on treatment longer than other atypicals (risperidone, quetiapine, ziprasidone) or the typical perphenazine. |
| 2004-12-14 | Eli Lilly and Company | Results Study Demonstrated Long-Term Treatment with Zyprexa® Reduced Violent Behavior in People with Schizophrenia Compared to Risperidone lilly.com ↗
Long-term treatment with Zyprexa® (olanzapine) significantly lowered risk of violent behavior in people with schizophrenia versus risperidone (Risperdal®, Janssen), according to a study published in the December issue of the Journal of Clinical Psychiatry. |
| 2001-02-23 | Eli Lilly and Company | Regulatory Eli Lilly and Company Notified of Abbreviated New Drug Application lilly.com ↗
Eli Lilly and Company Notified of Abbreviated New Drug Application |
All press releases naming this drug 87 releases
Evidence & citations 50 cited values
Every value below carries the sentence it was read from. 438 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olanzapine | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗423“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “Participants must be on Olanzapine 5 mg (minimum dose) to 30 mg (maximum dose), orally, daily or long-acting injectable versions (150-405 mg once every 2-4 weeks), as part of...” NCT02634463 ↗ “If the patient is within the primary medication arm and reports a 20-50% improvement in GAD symptoms compared to baseline after six weeks on the new medication, the medication...” NCT04478526 ↗ “Subjects (N = 44) who failed to respond to SSRIs were randomly assigned to 1 of 3 atypical antipsychotics -- olanzapine, quetiapine, or risperidone -- and were consecutively...” PMID 19422759 ↗ May 2009 “All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole...” NCT00256997 ↗ “Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per...” NCT01081769 ↗ “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗ “Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3...” PMID 32141723 ↗ Mar 2020 “Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\])” NCT01556763 ↗ “Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.” NCT00246259 ↗ |
| Known as | Arkolamyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | IM olanzapine depot | “Olanzapine Pamoate (OP) Depot (formerly referred to as IM olanzapine depot in previous versions of protocol) consists of OPM powder, which is suspended in an aqueous vehicle...” NCT01389908 ↗ |
| Known as | LY170053 | “The depot formulation of olanzapine (LY170053) to be evaluated in this study is olanzapine pamoate monohydrate (OPM) (the salt of pamoic acid and olanzapine), suitable for deep...” NCT01389908 ↗ |
| Known as | NRL-4 | “NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc.” NCT06600477 ↗ |
| Known as | OLA | “the AP olanzapine (OLA) inhibits the ability of a central insulin stimulus (acting at the level of the brain) to decrease endogenous glucose production (EGP)” NCT03741478 ↗2“This study examines the efficacy of low-dose combined olanzapine (OLA) and sertraline on depressive and negative symptoms in patients with TRS.” PMID 37153770 ↗ Apr 2023 “the dopamine (DA) 2 antagonist olanzapine (OLA) or placebo (PLA)” NCT00000373 ↗ |
| Known as | OLAI | “olanzapine long-acting injection (OLAI) by means of a categorical approach” PMID 22935168 ↗ Aug 2012 |
| Known as | Olansek | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapin | “olanzapine 10 mg (Olanzapin, Accord Healthcare B.V., The Netherlands) administered by feeding tube (or orally in awake patients)” NCT05895838 ↗ |
| Known as | Olanzapina | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine (as embonate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine (Zyprexa) | “Olanzapine (Zyprexa)” NCT00512070 ↗ |
| Known as | Olanzapine apotex | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine cipla | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine cipla (previously olanzapine neopharma) | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine component of lybalvi | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine component of symbyax | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine embonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine glenmark | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine glenmark europe | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00485680 ↗ |
| Known as | olanzapine LAI | “Early response/non-response to olanzapine LAI predicted later response/non-response with high sensitivity (85%), specificity (72%), PPV (78%), NPV (80%), and overall accuracy (79%).” PMID 21943257 ↗ Sep 20111“olanzapine LAI was also compared with” PMID 24041270 ↗ Sep 2013 |
| Known as | olanzapine long-acting injection | “a new injectable formulation of olanzapine, olanzapine long-acting injection (LAI), relative to placebo for treatment of acutely ill patients with schizophrenia.” PMID 18452346 ↗ May 20082“Olanzapine long-acting injection (LAI) is a salt-based depot antipsychotic combining olanzapine and pamoic acid.” PMID 20537130 ↗ Jun 2010 “olanzapine long-acting injection (LAI)” PMID 21823172 ↗ Aug 2011 |
| Known as | Olanzapine mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olanzapine Pamoate | “Olanzapine Pamoate (OP) Depot (formerly referred to as IM olanzapine depot in previous versions of protocol) consists of OPM powder, which is suspended in an aqueous vehicle...” NCT01389908 ↗ |
| Known as | Olanzapine pamoate anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | olanzapine pamoate monohydrate | “The depot formulation of olanzapine (LY170053) to be evaluated in this study is olanzapine pamoate monohydrate (OPM) (the salt of pamoic acid and olanzapine), suitable for deep...” NCT01389908 ↗ |
| Known as | Olanzapine Stada | “The olanzapine kit will consist of two capsules each containing two 2.5 mg tablets of olanzapine (Olanzapine Stada®, STADA Nordic); i.e. total dose 10mg.” NCT05635227 ↗ |
| Known as | Olanzapine Tablets | “Olanzapine Tablets” NCT05244577 ↗ |
| Known as | Olanzapine teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olazax | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Olazax disperzi | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | OLZ | “Study period 1 responders (mean modal daily OFC dosage, 10.8/27.8 mg) were randomized to OFC continuation treatment or olanzapine (OLZ) monotherapy starting at 10 mg (12 weeks, SP2).” PMID 19593175 ↗ Aug 20093“Chronically ill patients treated with olanzapine (OLZ) experienced significantly greater improvement in productivity” PMID 21586165 ↗ May 2011 “2. 320 begin double-blind treatment with olanzapine (OLZ)” NCT00014001 ↗ “Olanzapine (OLZ) is an atypical antipsychotic agent” NCT05243251 ↗ |
| Known as | OP Depot | “Olanzapine Pamoate (OP) Depot (formerly referred to as IM olanzapine depot in previous versions of protocol) consists of OPM powder, which is suspended in an aqueous vehicle...” NCT01389908 ↗ |
| Known as | OPM | “Olanzapine Pamoate (OP) Depot (formerly referred to as IM olanzapine depot in previous versions of protocol) consists of OPM powder, which is suspended in an aqueous vehicle...” NCT01389908 ↗ |
| Known as | QLG2072 | “generic olanzapine injection (QLG2072) in managing acute agitation associated with schizophrenia/bipolar I disorder in Chinese patients” PMID 41778148 ↗ Feb 2026 |
| Known as | Zalasta | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | ZYP | “This study will evaluate the efficacy of divaproex sodium (DVPX) vs. olanzapine (ZYP) vs. for alcohol relapse prevention and secondary mood stabilization.” NCT00221481 ↗ |
| Known as | Zypadhera | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Zyprexa | “The goals of this study are to:
Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these...” NCT00094640 ↗20“A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment...” NCT00329108 ↗ “This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia.” NCT00380224 ↗ “A Randomized Double-blind, Parallel Group Study Comparing Olanzapine (Zyprexa) With Haloperidol (Novo-peridol) for the Relief of Nausea and Vomiting in Patients With Advanced Cancer” NCT00124930 ↗ “This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.” NCT00048828 ↗ “This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.” NCT00000374 ↗ “whether Quetiapine (Seroquel) is significantly more effective than Olanzapine (Zyprexa) in improving neurocognitive deficits, community functioning and quality of life” NCT00182442 ↗ “This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.” NCT00183404 ↗ “Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)” NCT00177164 ↗ “olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel)” NCT00048802 ↗ “OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-4.” NCT05590923 ↗ |
| Known as | Zyprexa IntraMuscular | “The goals of this study are to: Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these...” NCT00094640 ↗ |
| Known as | Zyprexa relprevv | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Zyprexa velotab | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Known as | Zyprexa zydis | ChEMBL registry synonym — accepted as the source's own label CHEMBL715 ↗ |
| Action | Inhibit | “the dopamine (DA) 2 antagonist olanzapine (OLA)” NCT00000373 ↗2“Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL715 ↗ “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL715 ↗ |
| Modality | Small molecule | “The chemical designation is 2-methyl-4-4methyl-1 piperazinyl-10H-thienol (2,3-b)\[1,5\]benzodiazepine.” NCT02447835 ↗ |
| Route | Oral | “5 to 20 mg/d of oral olanzapine” PMID 17851042 ↗ Sep 2007 |
| Target | DRD4 | “We decided to test olanzapine because it also targets the D4 receptor, although not as strongly as clozapine” NCT00746785 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL715 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL715 ↗ |