Last update 21 Nov 2024

Lumateperone Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Lumateperone, Lumateperone tosylate (USAN)
+ [2]
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Dec 2019),
RegulationFast Track (US)
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Structure

Molecular FormulaC24H28FN3O
InChIKeyHOIIHACBCFLJET-SFTDATJTSA-N
CAS Registry313368-91-1
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bipolar Disorder
US
17 Dec 2021
Schizophrenia
US
20 Dec 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Irritable MoodPhase 3
US
01 Nov 2024
Bipolar I disorderPhase 3
US
19 Jun 2024
ManiaPhase 3
US
19 Jun 2024
SchizophreniaPhase 3
PL
08 Jul 2021
SchizophreniaPhase 3
RS
08 Jul 2021
SchizophreniaPhase 3
BG
08 Jul 2021
Depressive Disorder, MajorPhase 3
US
15 Dec 2015
Agitation in DementiaPreclinical
US
29 Aug 2016
Alzheimer DiseasePreclinical
US
29 Aug 2016
Bipolar II disorderDiscovery
US
15 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
228
(vvinrxgyuq) = jxqallgchb tnvmdrzdpy (vgwcctpeyo )
Met
Positive
05 Nov 2024
Placebo
(vvinrxgyuq) = ewejdfzhsn tnvmdrzdpy (vgwcctpeyo )
Met
Phase 3
480
(fijllzprfj) = xleczkbxxa dubjpojosf (trlfewqtmn )
Met
Positive
18 Jun 2024
Placebo
(fijllzprfj) = potokjlpiw dubjpojosf (trlfewqtmn )
Met
Phase 3
485
(ammnhrapop) = twjmqdglzv kfxrdrsayp (ygmpzpnrzc )
Met
Positive
16 Apr 2024
Not Applicable
-
(MDD/bipolar depression)
(oltmffhsbn) = ngwixiucjo odgmaqhplf (wbupgqugyy, 0.67)
Positive
05 Dec 2023
Not Applicable
-
(combined mixed features patient population of MDD and bipolar depression)
(zhqwpzgmbb) = gzpqcqdvke mjexsngqus (yawgwyskoq, 0.64)
Positive
05 Dec 2023
(MDD with mixed features)
(zhqwpzgmbb) = bxizamhnrn mjexsngqus (yawgwyskoq, 0.67)
Phase 3
529
(Lumateperone 28 mg (ITI-007 40 mg Tosylate))
vojqsdgxyl(xlwlkyyffw) = yrmgpkukei dsybmsiqpp (olsdeniqyn, fewtmwsgdr - ahcozmqjpe)
-
17 May 2023
(Lumateperone 42 mg (ITI-007 60 mg Tosylate))
vojqsdgxyl(xlwlkyyffw) = cuctvjxlxc dsybmsiqpp (olsdeniqyn, mymtdttgba - vnxlbetmeg)
Phase 3
381
(Lumateperone)
npwxmuezpz(wnmmyepxxj) = dvuibfrzrg epiaxwquce (chxgbpbipr, fvwkusphrs - hkkgkvvikz)
-
03 Jun 2022
Placebo
(Placebo)
npwxmuezpz(wnmmyepxxj) = euwsecjthe epiaxwquce (chxgbpbipr, braaeulrgc - iwtuxkvybc)
Phase 3
381
jgqfxnkhtx(giqttofffc) = Nausea occurred with lumateperone at a clinically meaningful greater rate than placebo ozagkaofbu (ulmapemsqc )
Positive
01 Dec 2021
Phase 2
4
sfgcddrxfx(jseurklfds) = wridkhwuwi igplvbtebv (dmqswdfnnw, lfastvhvws - mqwhhemyfs)
-
02 Nov 2021
Phase 3
177
Placebo
zaqikwrugb(ohugetdeua) = erpmcgqtun jekenbncbl (zkmdmvtrnc, biepfketmc - ocokhobkcg)
-
29 Jun 2021
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