Asset profile

Ulotaront

Small molecule

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Evidence outlook · lead readout

NCT04092686 · Schizophrenia

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

NCT04092686: This was a randomized, quadruple-masked, placebo-controlled trial with 464 participants and a clinical symptom-score primary endpoint (PANSS). The primary result was mixed: the 100 mg dose was statistically better than placebo, but the 75 mg dose was not, so the findings provide meaningful but incomplete evidence.

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 37 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Ulotaront: this drugPhase 3Small moleculeTAAR1 (trace amine-associated receptor 1)
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)
Dexmedetomidine (Igalmi)Approved——
Dexmedetomidine (Igalmi)ApprovedSmall moleculeAlpha-2 adrenergic receptor (agonist)
FazacloApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist)
HaloperidolApprovedSmall moleculeDopamine D2 receptor (antagonist)
Iloperidone (PD Psychosis Use) (Fanapt)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist)
Loxapine (Adasuve)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist)

…and 45 more. Research shows the complete landscape.

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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

(4 total)

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

2026 (1)
October 2026 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2026-10-20 · NCT06894212 · CT.gov ↗
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2028 (3)
March 2028 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2028-03 · NCT07225712 · CT.gov ↗
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October 2028 (1)
Phase 3Generalized Anxiety DisorderRecruiting
Est. primary completion 2028-10-25 · NCT07767903 · CT.gov ↗
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December 2028 (1)
Phase 3Generalized Anxiety DisorderRecruiting
Est. primary completion 2028-12-06 · NCT07759128 · 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 (11)
Phase 2/3 (2)
Phase 2 (4)
Phase 1 (13)