Drugs / Lurasidone
Lurasidone
also known as
lurasidone HCl · LATUDA · SM-13496 · lurasidone HCI · LRD · Lurasidona · LURASIDONE HYDROCHLORIDE · SM-13496 FREE BASE
Small molecule targets DRD2, HTR2A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizoaffective bipolar disorder 1 milestone | |||||
| Filed | Other | — | schizoaffective bipolar disorder | 2022-10-31 | “부광약품은 식품의약품안전처에 조현병 및 양극성 우울증 치료제 신약 ‘루라시돈(Lurasidone)’의 국내 품목허가를 10월 31일 신청했다고 밝혔다.” bukwang.co.kr ↗ |
| Filed schizophrenia 5 milestones | |||||
| Filed | Japan (PMDA) | LATUDA | schizophrenia | 2026-03-30 | “today announced that the Company has submitted a partial change application in Japan to add pediatric dosage and administration for LATUDA® Tablets” sumitomo-pharma.com ↗ |
| Filed | Other | — | schizophrenia | 2013-10-25 | “was submitted on October 25th, 2013 to the Taiwan Food and Drug Administration (TFDA) for the treatment of adult schizophrenia” sumitomo-pharma.com ↗ |
| Filed | Other | — | schizophrenia | 2013-04-15 | “acceptance of a marketing authorization application for lurasidone hydrochloride (generic name) for the treatment of schizophrenia in adults” sumitomo-pharma.com ↗ “applications for new drug approval for lurasidone with proposed indication of schizophrenia were submitted in November 2014 in Thailand” sumitomo-pharma.com ↗ “The Marketing Authorization Application was submitted in Switzerland in March 2012” sumitomo-pharma.com ↗ |
| Filed | EU (EMA) | — | schizophrenia | 2012-10-25 | “has confirmed the acceptance for review of the Marketing Authorization Application (MAA) for an atypical antipsychotic medication lurasidone hydrochloride for the treatment of...” sumitomo-pharma.com ↗ “submitted a marketing authorization application for lurasidone to the European Medicines Agency ("EMA") in September 2012 for the treatment of adults with schizophrenia” sumitomo-pharma.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2009-12-30 | “FDA recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia.” sumitomo-pharma.com ↗ “The new drug application (NDA) for lurasidone was submitted to the U.S. Food and Drug Administration (FDA) in December 2009” sumitomo-pharma.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) ahead of schedule for lurasidone” sumitomo-pharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | LATUDA | — | 2012-04-26 – 2018-03-05 | fda.gov ↗ |
| Approved | EU (EMA) | Latuda | — | 2014-03-21 | europa.eu ↗ |
| Approved | US (FDA) | LATUDA | — | 2010-10-28 | fda.gov ↗ |
Trials 68 · started per year
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EU approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07785102 | Sep → Dec 2026 expected | major depressive disorder | Mclean Hospital | Not yet recruiting | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT02174523 | Apr 2014 | schizophrenia | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02174510 | Mar → Apr 2014 | schizophrenia | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01620060 | Jun 2012 → May 2013 | autism, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01074632 | May → Sep 2009 | psychotic disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01082263 | Oct → Nov 2008 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01082289 | Sep → Oct 2008 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01082276 | Aug 2008 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01074073 | Aug → Oct 2008 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01082146 | Aug 2008 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00549666 | Aug → Dec 2007 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT06128213 | Mar → Jun 2024 | pyelonephritis | NeuroRx, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01731119 | Dec 2012 → Aug 2014 | autism, bipolar I disorder, bipolar II disorder, major depressive disorder +3 | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT00088621 | Jul 2004 → Oct 2005 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00088634 | May → Dec 2004 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 2 | NCT00044005 | Sep 2002 → Nov 2003 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00044044 | Jul 2002 → May 2003 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07227103 | Sep 2026 → Dec 2027 expected | atypical depressive disorder | NeuroRx, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03402152 | Nov 2018 → Jan 2021 | bipolar depression | NeuroRx, Inc. | Completed | No outcome recorded |
| Phase 336 trials · 12 met primary · 7 missed | ||||||
| Phase 3 | NCT07781293 | Sep 2026 → Oct 2027 expected | major depressive disorder | Bukwang Pharmaceutical | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04383691 | Dec 2020 → Dec 2022 | bipolar depression | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03465787 | Apr 2018 → Oct 2022 | schizophrenia | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT02731612 | May 2017 → Dec 2024 | bipolar disorder | Lakshmi N Yatham | Completed | No outcome recorded |
| Phase 3 | NCT02147379 | May 2014 → Oct 2015 | bipolar I disorder | University of British Columbia | Completed | Met primary |
| Phase 3 | NCT02046369 | Mar 2014 → Oct 2016 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT01986101 | Feb 2014 → Feb 2017 | bipolar depression | Sumitomo Pharma Co., Ltd. | Completed | Mixed |
| Phase 3 | NCT01986114 | Jan 2014 → Feb 2018 | bipolar I disorder | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02002832 | Dec 2013 → Apr 2015 | schizophrenia | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Completed | Missed primary |
| Phase 3 | NCT01914393 | Sep 2013 → Oct 2018 | autism, bipolar depression, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01911429 | Aug 2013 → Dec 2015 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT01911442 | Aug 2013 → Nov 2014 | autism | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT01821378 | May 2013 → Jun 2014 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Mixed |
| Phase 3 | NCT01614912 | Aug 2012 → May 2015 | schizophrenia | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01614899 | Jul 2012 → Nov 2014 | schizophrenia | Sumitomo Pharma Co., Ltd. | Completed | Missed primary |
| Phase 3 | NCT01575561 | Jun 2012 → Jul 2015 | bipolar I disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01566162 | Apr 2012 → Nov 2013 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01423240 | Jan → Dec 2012 | major depressive disorder | Sumitomo Pharma America, Inc. | Withdrawn | Met primary |
| Phase 3 | NCT01423253 | Sep 2011 → Oct 2013 | major depressive disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01421134 | Sep 2011 → Oct 2014 | major depressive disorder | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT01435928 | Sep 2011 → Aug 2013 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT01485640 | Jun 2011 → Feb 2014 | bipolar disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01358357 | Jun 2011 → Apr 2015 | bipolar I disorder | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT01284517 | Nov 2010 → Aug 2012 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT01143090 | Aug 2010 → Nov 2011 | schizoaffective disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01173874 | Jul 2010 → Oct 2013 | schizophrenia | New York State Psychiatric Institute | Completed | Missed primary |
| Phase 3 | NCT01143077 | Jun 2010 → May 2011 | schizoaffective disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00868959 | Apr 2009 → Feb 2013 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00868699 | Apr 2009 → Feb 2012 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00868452 | Apr 2009 → Dec 2011 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00789698 | Dec 2008 → Jul 2011 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00790192 | Oct 2008 → Jul 2010 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00711269 | Jun 2008 → Apr 2010 | schizophrenia | Sumitomo Pharma Co., Ltd. | Completed | Missed primary |
| Phase 3 | NCT00641745 | Mar 2008 → Jul 2010 | schizoaffective disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00615433 | Jan 2008 → Dec 2009 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00549718 | Oct 2007 → Oct 2010 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 410 trials | ||||||
| Phase 4 | NCT07806227 | Nov 2026 → Jul 2028 expected | bipolar depression | Martin Lan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06433635 | Oct 2024 → Feb 2030 expected | bipolar I disorder, depressive disorder | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05351736 | Jan 2022 → Jan 2024 | schizophrenia | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 4 | NCT05213143 | Dec 2021 → Nov 2022 | schizophrenia | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT05011669 | Aug 2021 → Apr 2023 | schizophrenia | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03902613 | Feb → Aug 2019 | bipolar depression | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT03393026 | Jan 2018 → Sep 2019 | schizophrenia | Standard Chem. & Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03304457 | Aug 2017 → Mar 2018 | schizophrenia | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT01932541 | Jan 2017 → Jul 2018 | bipolar I disorder, bipolar II disorder, manic bipolar affective disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT01569659 | Oct 2011 → Jul 2015 | schizophrenia | Northwestern University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05480150 | Nov 2021 → Dec 2026 expected | bipolar disorder, major depressive disorder | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT02239094 | Jan 2015 → Sep 2016 | bipolar depression | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05779267 | — | — | NeuroRx, Inc. | Available | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT03565068 Background | Jun 2018 → Apr 2020 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02181803 Background | Aug 2014 → Apr 2015 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03557931 Background | Jul 2018 → Oct 2019 | schizophrenia | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
| Phase 2 | NCT02974010 Comparator | Jan → Aug 2018 | bipolar depression | NeuroRx, Inc. | Completed | Met primary |
| Phase 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | Missed primary |
| Phase 2/3 | NCT03395392 Comparator | May 2022 → Feb 2024 | bipolar depression | NeuroRx, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03396068 Comparator | Dec 2019 → Dec 2024 | bipolar depression | NeuroRx, Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT01979679 Comparator | Dec 2008 → Oct 2013 | schizophrenia | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT05741502 Comparator | Aug 2023 → Jan 2026 | schizophrenia | Ohio State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02282085 Comparator | Dec 2014 → Dec 2017 | schizophrenia | Matt Byerly | Unknown | No outcome recorded |
| Phase 4 | NCT02237417 Comparator | Sep 2014 → Nov 2018 | schizophrenia | University of Utah | Completed | No outcome recorded |
| Phase 4 | NCT01833897 Background | Mar 2013 → Jul 2014 | bipolar disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT02199743 Comparator | Feb 2013 → Jun 2016 | schizoaffective disorder, schizophrenia | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00806234 Comparator | Jan 2009 → Mar 2014 | psychotic disorder | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Sumitomo Pharma America, Inc. | Regulatory Sumitomo Pharma Submits Partial Change Application in Japan to Add Pediatric Dosage and Administration for LATUDA in Schizophrenia sumitomo-pharma.com ↗ |
| 2023-09-18 | Bukwang Pharmaceutical | Regulatory 부광약품, 조현병 및 제 1 형 양극성 우울증 치료제 신약 '라투다정' 보험 급여 등재 신청 bukwang.co.kr ↗
부광약품은 조현병 및 제 1 형 양극성 우울증 치료제 신약 ‘라투다정’ (성분명 : 루라시돈(Lurasidone))의 의약품 보험급여 등재 신청을 하였다고 밝혔다. |
| 2022-10-31 | Bukwang Pharmaceutical | Regulatory 부광약품, 조현병 및 양극성 우울증 치료제 신약 '루라시돈' 품목허가 신청 bukwang.co.kr ↗
부광약품은 식품의약품안전처에 조현병 및 양극성 우울증 치료제 신약 ‘루라시돈(Lurasidone)’의 국내 품목허가를 10월 31일 신청했다고 밝혔다. |
| 2021-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 14th May, 2021, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces USFDA Final Approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. |
| 2020-03-25 | Sumitomo Pharma America, Inc. | Regulatory Sumitomo Dainippon Pharma Announces Approval of Atypical Antipsychotic Agent, LATUDA Tablets in Japan sumitomo-pharma.com ↗
Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced today that a new drug application for LATUDA ® Tablets (generic name: lurasidone hydrochloride, hereinafter, "this Drug"), an atypical antipsychotic agent for schizophrenia and bipolar depression, was approved in Japan on March 25. |
| 2019-07-31 | Sumitomo Pharma America, Inc. | Regulatory Sumitomo Dainippon Pharma Submits New Drug Application for Approval of Manufacturing and Marketing for Lurasidone in Japan for the Treatment of Schizophrenia and Bipolar Depression sumitomo-pharma.com ↗
Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced today that it has submitted a new drug application for approval of manufacturing and marketing for lurasidone hydrochloride (generic name) in Japan for the treatment of schizophrenia and bipolar depression. |
| 2019-03-22 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Lurasidone Hydrochloride Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Lurasidone Hydrochloride Tablets USP (US RLD – Latuda Tablets), in the strengths of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. |
| 2019-01-29 | Sumitomo Pharma America, Inc. | Regulatory Sumitomo Dainippon Pharma Announces the Approval of Atypical Antipsychotic Latuda (lurasidone HCl) for the Treatment of Patients with Schizophrenia in China sumitomo-pharma.com ↗ |
| 2019-01-10 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Positive Topline Results from a Phase III Clinical Study (JEWEL Study) of Lurasidone, an Atypical Antipsychotic Agent, in the Treatment of Patients with Schizophrenia sumitomo-pharma.com ↗
In addition, the lurasidone group demonstrated statistically significant improvement compared to the placebo group on the change from baseline of the Clinical Global Impressions Severity scale (CGI-S) *2 after 6 weeks, a secondary efficacy endpoint. |
| 2019-01-07 | Lupin Limited | Regulatory Lupin receives FDA approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg lupin.com ↗
Pharma major Lupin announced that it has received approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. |
| 2018-10-15 | Lupin Limited | Regulatory Lupin receives tentative FDA approval for generic Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg lupin.com ↗
Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. |
| 2017-06-09 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Topline Results from a Phase 3 Study of Lurasidone, an Atypical Antipsychotic Agent, in the Treatment of Patients with Bipolar l Depression sumitomo-pharma.com ↗
The lurasidone 80 - 120 mg/day group (-12.6) also demonstrated improvement compared to placebo but the difference was not statistically significant (adjusted p=0.057). |
| 2016-10-26 | Standard Chem. & Pharm. Co., Ltd. | Regulatory 原開發廠精神科新藥 台灣為亞洲第一個上市國家 生達 ( 1720 ) 獨家代理 com.tw ↗
目前已取得台灣衛生福利部食品藥物管理署核准，即日起正式供貨 |
| 2015-04-24 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Makes a Follow-up Announcement on the Preliminary Findings from a Phase III Clinical Study (PASTEL Study) of Lurasidone, an Atypical Antipsychotic Agent, in the Treatment of Patients with Schizophrenia sumitomo-pharma.com ↗
In neither group, however, the difference was statistically significant. |
| 2014-12-25 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Preliminary Findings from a Phase III Clinical Study (PASTEL Study) of Lurasidone, an Atypical Antipsychotic Agent, in the Treatment of Patients with Schizophrenia sumitomo-pharma.com ↗
The lurasidone 80 mg/day group (-17.5) also demonstrated improvement compared to placebo but the difference was not statistically significant. |
| 2014-04-03 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma Announces Health Canada Approval of LATUDA (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Patients with Bipolar Depression sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan; President: Masayo Tada) announced that Health Canada approved on March 31 (local time) the use of LATUDA ® (lurasidone HCl) as monotherapy or as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I disorder. |
| 2014-03-31 | Takeda | Regulatory Dainippon Sumitomo Pharma and Takeda Announce the European Marketing Authorization for Latuda ® (lurasidone) - a New Atypical Antipsychotic Medication for Adults with Schizophrenia takeda.com ↗
Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Head Office: Osaka, Japan) today jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda ® (lurasidone) for the treatment of schizophrenia in adults. |
| 2014-03-31 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma and Takeda Announce the European Marketing Authorization for Latuda (lurasidone) - a New Atypical Antipsychotic Medication for Adults with Schizophrenia sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Head Office: Osaka, Japan) today jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda ® (lurasidone) for the treatment of schizophrenia in adults. |
| 2014-03-25 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma Announces the Marketing Authorization in Australia for Atypical Antipsychotic Agent Latuda sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Headquarters: Osaka, Japan; President: Masayo Tada) announces that the Australian Therapeutic Goods Administration ("TGA") granted the marketing authorization for Latuda ® (lurasidone hydrochloride) for the treatment of adults with schizophrenia on March 19, 2014 (Australia time). |
| 2014-01-27 | Takeda | Regulatory Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for Adults with Schizophrenia takeda.com ↗
The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. |
| 2014-01-27 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for Adults with Schizophrenia sumitomo-pharma.com ↗
The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. |
| 2013-10-28 | Sumitomo Pharma America, Inc. | Regulatory Application for Marketing Approval Submitted in Taiwan for Atypical Antipsychotic Agent Lurasidone sumitomo-pharma.com ↗
This marks the first application submission for lurasidone in Asia. |
| 2013-08-13 | Sumitomo Pharma America, Inc. | Regulatory DSP and Takeda Announce Approval of the Marketing Authorization Application for Atypical Antipsychotic Agent Lurasidone in Switzerland sumitomo-pharma.com ↗
Takeda Pharma AG, a wholly owned subsidiary of Takeda, obtained the approval of the Marketing Authorization Application by Swissmedic for atypical antipsychotic medication lurasidone hydrochloride ("lurasidone") for the treatment of patients with schizophrenia. |
| 2013-04-15 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma Submits Marketing Authorization Application in Australia for Atypical Antipsychotic Agent Lurasidone sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces that the Australian Therapeutic Goods Administration (TGA) has confirmed the acceptance of a marketing authorization application for lurasidone hydrochloride (generic name) for the treatment of schizophrenia in adults. |
| 2012-10-25 | Sumitomo Pharma America, Inc. | Regulatory DSP and Takeda Announce the Acceptance of the European Medicines Agency Submission of an Atypical Antipsychotic Agent Lurasidone sumitomo-pharma.com ↗
today announced that the European Medicines Agency (EMA) has confirmed the acceptance for review of the Marketing Authorization Application (MAA) for an atypical antipsychotic medication lurasidone hydrochloride for the treatment of schizophrenia. |
| 2012-04-24 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma Co. Reports that Latuda (lurasidone HCl) Met Primary and Key Secondary Endpoints in Two Phase III Trials in Bipolar I Depression sumitomo-pharma.com ↗
On an overall basis in both studies, patients with bipolar I depression treated with LATUDA experienced statistically significant improvements in symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), compared to patients taking placebo. |
| 2011-05-11 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces Pan-Asia study results for lurasidone, an atypical antipsychotic agent, in the treatment of schizophrenia sumitomo-pharma.com ↗
This clinical trial is viewed as a failed study, as it was unsuccessful in establishing assay sensitivity. |
| 2011-01-25 | Sumitomo Pharma America, Inc. | Results Completion of Long-Term Phase 3 Safety Trial for Latuda (lurasidone HCl) sumitomo-pharma.com ↗
In the 12-month study, once-daily LATUDA was found to be well-tolerated and consistent with previous evaluations of its safety and tolerability. |
| 2010-11-02 | Sumitomo Pharma America, Inc. | Results LATUDA (lurasidone HCl) SIGNIFICANTLY REDUCED SYMPTOMS OF SCHIZOPHRENIA IN NEW CLINICAL STUDY sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. announced today positive preliminary findings from a LATUDA ® (lurasidone HCl) clinical trial, PEARL 3. |
| 2010-03-11 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia sumitomo-pharma.com ↗
"We are pleased that the lurasidone NDA has been accepted for review by the FDA," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. |
| 2009-08-26 | Sumitomo Pharma America, Inc. | Results LURASIDONE DEMONSTRATED EFFICACY IN TREATING PATIENTS WITH SCHIZOPHRENIA IN PIVOTAL PHASE 3 STUDY sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from PEARL 2 - a phase 3 clinical trial of lurasidone for the treatment of patients with schizophrenia. |
| 2009-06-03 | Sumitomo Pharma America, Inc. | Results STUDY DEMONSTRATING LURASIDONE IS EFFECTIVE IN PATIENTS WITH SCHIZOPHRENIA PUBLISHED IN THE JOURNAL OF CLINICAL PSYCHIATRY sumitomo-pharma.com ↗
Lurasidone 80 mg/day produced statistically significant improvement versus placebo in both primary and secondary efficacy assessments at all study visits starting at day 3. |
| 2009-05-21 | Sumitomo Pharma America, Inc. | Results DAINIPPON SUMITOMO PHARMA ANNOUNCES LURASIDONE PHASE III DATA IN PATIENTS WITH SCHIZOPHRENIA sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from the first phase 3 clinical trial for lurasidone, which is under clinical development globally, for the treatment of patients with schizophrenia. |
All press releases naming this drug 57 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 84 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lurasidone | “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗78“Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.” NCT03319953 ↗ “Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics” NCT05741502 ↗ “Lurasidone is a novel compound synthesized by SEPRACOR, Inc.for the treatment of patients with schizophrenia” NCT01173874 ↗ “Quetiapine, olanzapine-fluoxetine, and lurasidone are approved treatments for bipolar depression.” NCT01833897 ↗ “NRX-101 is a combination capsule of fixed dose d-cycloserine (175 mg) and lurasidone (8.25 mg)” NCT07785102 ↗ “Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia” NCT01614912 ↗ “Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)” NCT02002832 ↗ “In adults, lurasidone appears to cause minimal weight gain.” NCT01731119 ↗ “D-cycloserine/lurasidone fixed dose combination” NCT05779267 ↗ “D-cycloserine 175mg + Lurasidone 8.5mg” NCT07227103 ↗ |
| Known as | LATUDA | “To characterize lurasidone PK profile following single and multiple oral doses of 20, 40,80, 120 or 160 mg/day lurasidone in the targeted pediatric/adolescent population (6-17...” NCT01620060 ↗7“The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of...” NCT01731119 ↗ “They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda).” NCT03902613 ↗ “Oral Use Lurasidone HCl Tablet (LATUDA®)” NCT03393026 ↗ “lurasidone HCI (Latuda®)” NCT02237417 ↗ “Latuda (Lurasidone)” NCT01932541 ↗ “Lurasidone (Latuda)” NCT07806227 ↗ “Latuda® 40mg/d” NCT05011669 ↗ |
| Known as | LRD | “D-cycloserine (DCS), lurasidone (LRD), rapid intermittent Theta Burst Stimulation (iTBS)” NCT07785102 ↗ |
| Known as | Lurasidona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237021 ↗ |
| Known as | lurasidone HCI | “Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.” NCT01284517 ↗1“lurasidone HCI (Latuda®)” NCT02237417 ↗ |
| Known as | lurasidone HCl | “Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia.” NCT01143090 ↗11“Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia.” NCT01143077 ↗ “oral NRX-101 (a fixed dose combination of 487.5 mg D-cycloserine (DCS) and 16.5 mg lurasidone HCl (lurasidone) twice daily for 10 days” NCT06128213 ↗ “Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia” NCT01614912 ↗ “Lurasidone HCl is a compound being developed for the treatment of schizophrenia.” NCT00790192 ↗ “A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia” NCT01614899 ↗ “Midazolam Drug-Drug Interaction Study With Lurasidone HCl” NCT01082263 ↗ “A Study of Lurasidone HCl in Subjects With Schizophrenia” NCT03393026 ↗ “Lurasidone HCl will be given twice a day by mouth” NCT03395392 ↗ “Lurasidone HCL 2 80mg tablets, QD” NCT03465787 ↗ “Drug: SM-13496 (lurasidone HCl)” NCT00711269 ↗ |
| Known as | LURASIDONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237021 ↗ |
| Known as | SM-13496 | “A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia” NCT00044005 ↗6“A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia” NCT00088634 ↗ “Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia” NCT01614912 ↗ |
| Known as | SM-13496 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237021 ↗ |
| Action | Inhibit | “As expected for D2 antagonists, drug-placebo differences on negative symptoms with lurasidone were not specific to the subpopulation having the MPNS construct.” PMID 39144777 ↗ Apr 20222“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1237021 ↗ “Dopamine D2 receptor antagonist” CHEMBL1237021 ↗ |
| Modality | Small molecule | — CHEMBL1237021 ↗ |
| Route | Oral | “Lurasidone 20mg oral tablet taken once daily for 6-months” NCT00044005 ↗ |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL1237021 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL1237021 ↗ |