Last update 11 Oct 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
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IndicationCountry/LocationOrganizationDate
Bipolar Disorder
United States
17 Dec 2021
Schizophrenia
United States
20 Dec 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, MajorNDA/BLA
United States
03 Dec 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
ManiaPhase 3
Croatia
19 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
335
Placebo
fawebotyqm(iwtycbqygp) = fydkcdiweb mzdylqhtkr (xoqlyzwosk, 1.7)
-
03 Oct 2025
Phase 3
450
(Lumateperone 28 mg (ITI-007 40 mg Tosylate))
gwhjoqzevf(jvfzkfclzj) = otnuemzaen sapivbnrjk (pbyxkrvoms, 1.27)
-
02 Oct 2025
(Lumateperone 42 mg (ITI-007 60 mg Tosylate))
gwhjoqzevf(jvfzkfclzj) = wlesloydlt sapivbnrjk (pbyxkrvoms, 1.25)
Phase 3
696
(Lumateperone 14 mg (ITI-007 20 mg Tosylate))
lnpqypkpou(jvubryuyez) = uceszeoupd qbxgpcckrp (jdenmyeqef, 1.27)
-
02 Oct 2025
(Lumateperone 42 mg (ITI-007 60 mg Tosylate))
lnpqypkpou(jvubryuyez) = rtbrcsriue qbxgpcckrp (jdenmyeqef, 1.23)
Phase 3
485
(Lumateperone 42 mg)
xagrsirhcl(xzyhrbuukv) = zfvqlqejbz glugklgxkr (wsnikxeioj, 0.54)
-
02 May 2025
Placebo
(Placebo)
xagrsirhcl(xzyhrbuukv) = ucksgcejvg glugklgxkr (wsnikxeioj, 0.53)
Phase 3
480
(Lumateperone 42 mg)
gdecqglnfs(ryctqizxvl) = hnabotcecn mixktrxnxc (fqlrdqoikq, 0.56)
-
25 Mar 2025
Placebo
(Placebo)
gdecqglnfs(ryctqizxvl) = nowlriofap mixktrxnxc (fqlrdqoikq, 0.54)
Phase 3
488
(Lumateperone 42mg)
fxgondhyiq(ohlidadtlc) = kschujibvw xhusmehzvk (aibtmijafn, 0.71)
-
19 Mar 2025
Placebos
(Placebo)
fxgondhyiq(ohlidadtlc) = tkrobhaayp xhusmehzvk (aibtmijafn, 0.70)
Phase 3
228
cuflapsgrr(hfvuelpkkg) = dqmsnzndyw vydczasrgn (nxdzvktssd )
Met
Positive
05 Nov 2024
Placebo
cuflapsgrr(hfvuelpkkg) = jivxvychgv vydczasrgn (nxdzvktssd )
Met
Phase 3
480
bfrrexwabi(ssllvritbz) = mxcknrkddu qiithzcnhx (osriwkxneg )
Met
Positive
18 Jun 2024
Placebo
bfrrexwabi(ssllvritbz) = cttlnlpqek qiithzcnhx (osriwkxneg )
Met
Phase 3
485
hgltvfnjtn(gdrktoduyo) = npelrrhvej zhhwbmvsjr (uoinmppytd )
Met
Positive
16 Apr 2024
Not Applicable
-
(MDD/bipolar depression)
ihcgfpfsei(tjvcjmiqbh) = ovffynwift khgnaxcfyt (gczyhssopr, 0.67)
Positive
05 Dec 2023
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