Drugs / Lurasidone
Lurasidone
also known as
Lurasidone HCL · Latuda · SM-13496 · lurasidone HCI · DSP-1349M · Lurasidona · LURASIDONE HYDROCHLORIDE · SM-13496 FREE BASE
Small molecule targets DRD2, HTR2A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 66 · started per year
today
US approved 2010
EU approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT03627195 | Jun 2018 → Mar 2019 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| 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 | NCT01082146 | 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 | NCT01082276 | 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 | ||||||
| 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 | No outcome recorded |
| 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 335 trials | ||||||
| Phase 3 | NCT04383691 | Dec 2020 → Dec 2022 | bipolar depression | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02046369 | Mar 2014 → Oct 2016 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01986101 | Feb 2014 → Feb 2017 | bipolar depression | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01914393 | Sep 2013 → Oct 2018 | autism, bipolar depression, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01911442 | Aug 2013 → Nov 2014 | autism | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01911429 | Aug 2013 → Dec 2015 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01821378 | May 2013 → Jun 2014 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01421134 | Sep 2011 → Oct 2014 | major depressive disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01435928 | Sep 2011 → Aug 2013 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01423253 | Sep 2011 → Oct 2013 | major depressive disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01358357 | Jun 2011 → Apr 2015 | bipolar I disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01485640 | Jun 2011 → Feb 2014 | bipolar disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01284517 | Nov 2010 → Aug 2012 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01143077 | Jun 2010 → May 2011 | schizoaffective disorder, schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00868699 | Apr 2009 → Feb 2012 | bipolar depression | 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 | NCT00868452 | Apr 2009 → Dec 2011 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00789698 | Dec 2008 → Jul 2011 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00790192 | Oct 2008 → Jul 2010 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00711269 | Jun 2008 → Apr 2010 | schizophrenia | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00549718 | Oct 2007 → Oct 2010 | schizophrenia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| 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 |
| 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 |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 23 trials | ||||||
| Phase 2 | NCT03557931 Background | Jul 2018 → Oct 2019 | schizophrenia | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02974010 Comparator | Jan → Aug 2018 | bipolar depression | NeuroRx, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03395392 Comparator | May 2022 → Feb 2024 | bipolar depression | NeuroRx, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| 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 46 trials | ||||||
| Phase 4 | NCT05741502 Comparator | Aug 2023 → Jan 2026 | schizophrenia | Ohio State University | Terminated | No outcome recorded |
| 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 |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-05-07 | Takeda | Sumitomo Dainippon Pharma Co. Ltd. and Takeda Pharmaceutical Company Limited Announce Decision to Terminate their Agreement for the Joint Development and Exclusive Commercialization of Latuda ® (lurasidone) - an Atypical Antipsychotic Agent, in Europe takeda.com ↗ |
| 2014-05-26 | Daiichi Sankyo | Dainippon Sumitomo Pharma and Daiichi Sankyo Cooperate on Lurasidone, an Atypical Antipsychotic Agent, in Four South American Countries daiichisankyo.com ↗ |
| 2014-03-31 | Takeda | Dainippon Sumitomo Pharma and Takeda Announce the European Marketing Authorization for Latuda ® (lurasidone) - a New Atypical Antipsychotic Medication for Adults with Schizophrenia takeda.com ↗ |
| 2014-01-27 | Takeda | Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for Adults with Schizophrenia takeda.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 82 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 ↗75“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 ↗ “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 ↗ “aripirprazole, lurasidone, risperidone” NCT03565068 ↗ “lurasidone HCI (Latuda®)” NCT02237417 ↗ “Lurasidone” NCT01932541 ↗ |
| Known as | DSP-1349M | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03627195 ↗ |
| 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 ↗6“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 ↗ “Latuda® 40mg/d” NCT05011669 ↗ |
| 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 ↗ “Drug: Lurasidone HCl” NCT01074073 ↗ |
| 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 ↗ |