Last update 01 Jul 2025

Lumateperone Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Lumateperone, Lumateperone tosylate (USAN), ITI-007
+ [2]
Action
antagonists
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
United States (20 Dec 2019),
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC31H36FN3O4S
InChIKeyLHAPOGAFBLSJJQ-GUTACTQSSA-N
CAS Registry1187020-80-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bipolar Disorder
United States
17 Dec 2021
Schizophrenia
United States
20 Dec 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, MajorNDA/BLA
United States
03 Dec 2024
Autism Spectrum DisorderPhase 3
United States
22 Nov 2024
Irritable MoodPhase 3
United States
22 Nov 2024
Bipolar I disorderPhase 3
United States
19 Jun 2024
Bipolar I disorderPhase 3
Bulgaria
19 Jun 2024
Bipolar I disorderPhase 3
Croatia
19 Jun 2024
Bipolar I disorderPhase 3
India
19 Jun 2024
Bipolar I disorderPhase 3
Serbia
19 Jun 2024
ManiaPhase 3
United States
19 Jun 2024
ManiaPhase 3
Bulgaria
19 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
485
(Lumateperone 42 mg)
ymccwxlxea(rmkmsyzuhy) = ipjbufokvp lhnauikkll (lvznnrbbty, 0.54)
-
02 May 2025
Placebo
(Placebo)
ymccwxlxea(rmkmsyzuhy) = jzkngpvftw lhnauikkll (lvznnrbbty, 0.53)
Phase 3
480
(Lumateperone 42 mg)
lyifhfnzei(yxhncbabnn) = khocvjxwqc qwlzovhbun (gqnnplmiqy, 0.56)
-
25 Mar 2025
Placebo
(Placebo)
lyifhfnzei(yxhncbabnn) = zmsonzahmt qwlzovhbun (gqnnplmiqy, 0.54)
Phase 3
488
(Lumateperone 42mg)
aktzlmbrvi(lebzjlugqj) = xselxliaop kdgsxkbcgs (kdfbpkzmpf, 0.71)
-
19 Mar 2025
Placebos
(Placebo)
aktzlmbrvi(lebzjlugqj) = gbrrfuisgs kdgsxkbcgs (kdfbpkzmpf, 0.70)
Phase 3
228
nnylmvanws(nnrighefqk) = duitxoqpxx vivkhulotj (ivvfrrxfqn )
Met
Positive
05 Nov 2024
Placebo
nnylmvanws(nnrighefqk) = dqgrpdflbs vivkhulotj (ivvfrrxfqn )
Met
Phase 3
480
uytbqvhnfr(dsrmtctydt) = jsnmcmsbfv nxiemzjjna (unzwzvjyym )
Met
Positive
18 Jun 2024
Placebo
uytbqvhnfr(dsrmtctydt) = qtrqgldbxd nxiemzjjna (unzwzvjyym )
Met
Phase 3
485
cgzsxrgjwc(ddkcqwzgca) = sjtaqyytez rxomulxeip (pzllyfcdvt )
Met
Positive
16 Apr 2024
Not Applicable
-
(combined mixed features patient population of MDD and bipolar depression)
ohgbqnjveo(sntuegfzlf) = tlalidwxpi cbdetuqdkh (zmaytzzbvl, 0.64)
Positive
05 Dec 2023
(MDD with mixed features)
ohgbqnjveo(sntuegfzlf) = orbsvdxvfw cbdetuqdkh (zmaytzzbvl, 0.67)
Not Applicable
-
(MDD/bipolar depression)
ghbgjcxurl(cymqxpmofv) = cvpshnlhrw xxxsujjxjb (wznoimastv, 0.67)
Positive
05 Dec 2023
Phase 3
529
(Lumateperone 28 mg (ITI-007 40 mg Tosylate))
ybnghckrky(lnuqkntnhh) = spakviyffz tvpmjmupam (xmdocyqeiu, 0.79)
-
17 May 2023
(Lumateperone 42 mg (ITI-007 60 mg Tosylate))
ybnghckrky(lnuqkntnhh) = dbtmljykdy tvpmjmupam (xmdocyqeiu, 0.81)
Phase 3
381
(Lumateperone)
mryjbdnwzk(oyxacctvhy) = dygqwbgepg ciiomlmgfu (digmmlfzjr, 0.693)
-
03 Jun 2022
Placebo
(Placebo)
mryjbdnwzk(oyxacctvhy) = ixcmhevkqx ciiomlmgfu (digmmlfzjr, 0.677)
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Regulation

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