Asset profile

Lumateperone · Caplyta

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Major Depressive Disorder, Schizophrenia

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

track record: Reliable signal

How the evidence outlook works ↗

Competitive landscape

118 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 117 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Lumateperone (Caplyta): this drugApprovedSmall moleculeSerotonin 5-HT2A / dopamine D1-D2 receptor
Risperidone (Risperdal)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist), Serotonin 5-HT2A / dopamine D1-D2 receptor
Aripiprazole (Abilify Maintena)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT1A receptors (partial agonist), Dopamine D2/D3 and serotonin 5-HT1A receptor, Dopamine D2 receptor (partial agonist)
Aripiprazole (Abilify MyCite)ApprovedCombinationDopamine D2 and serotonin 5-HT1A receptors (partial agonist); serotonin 5-HT2A receptor (antagonist)
Aripiprazole (Abilify)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Aripiprazole Lauroxil (Aristada Initio)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Aripiprazole Lauroxil (Aristada)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
AsenapineApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist)
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Cariprazine (Vraylar)ApprovedSmall moleculeDopamine D3/D2 receptor (partial agonist)
ClozapineApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist)
Cyclobenzaprine (Tonmya)ApprovedSmall molecule5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism)
Dexmedetomidine (Igalmi)Approved——
Dexmedetomidine (Igalmi)ApprovedSmall moleculeAlpha-2 adrenergic receptor (agonist)
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor

…and 103 more. Research shows the complete landscape.

Research

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(14 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (2)
December 2026 (2)
Phase 3SchizophreniaRecruiting
Est. primary completion 2026-12 · NCT06482554 · CT.gov ↗
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Phase 4SchizophreniaRecruiting
Est. primary completion 2026-12 · NCT06174116 · CT.gov ↗
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2027 (5)
March 2027 (1)
Phase 4Bipolar 1 DepressionNot yet recruiting
Est. primary completion 2027-03 · NCT07676669 · CT.gov ↗
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April 2027 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2027-04-05 · NCT05850689 · CT.gov ↗
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June 2027 (2)
Phase 3Irritability Associated With Autism Spectrum DisorderRecruiting
Est. primary completion 2027-06-21 · NCT06706674 · CT.gov ↗
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Phase 3Irritability Associated With Autism Spectrum DisorderRecruiting
Est. primary completion 2027-06-21 · NCT06690398 · CT.gov ↗
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July 2027 (1)
Phase 2Stuttering, AdultRecruiting
Est. primary completion 2027-07-31 · NCT07734103 · CT.gov ↗
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2028 (3)
January 2028 (2)
Phase 4Major Depressive DisorderNot yet recruiting
Est. primary completion 2028-01 · NCT07824206 · CT.gov ↗
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Phase 4Bipolar Depression Depressed Phase, Obesity & OverweightNot yet recruiting
Est. primary completion 2028-01-31 · NCT07699445 · CT.gov ↗
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June 2028 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2028-06 · NCT07623135 · CT.gov ↗
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2029 (1)
September 2029 (1)
Phase 3Major Depressive DisorderNot yet recruiting
Est. primary completion 2029-09-20 · NCT07747389 · CT.gov ↗
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2030 (1)
January 2030 (1)
Phase 4Major Depressive Diorder, Early Life TraumaNot yet recruiting
Est. primary completion 2030-01 · NCT07369115 · CT.gov ↗
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2031 (1)
October 2031 (1)
Phase 3Bipolar DepressionRecruiting
Est. primary completion 2031-10-31 · NCT06372964 · CT.gov ↗
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2032 (1)
April 2032 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2032-04-28 · NCT06229210 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (21)
Phase 2 (5)
Phase 1/2 (1)
Phase 1 (4)
Phase 4 (6)