Asset profile

HS-10380

Small molecule

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Phase 3underway

Evidence outlook · registrational

Schizophrenia: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2028-07-31.

NCT07550387: The study randomized 363 participants and used quadruple blinding with both placebo and active aripiprazole comparator arms. Its primary endpoint was the clinical PANSS symptom score, but results are not posted, so whether the primary comparison was met is unknown.

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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
HS-10380: this drugPhase 3Small moleculeDopamine D2/D3 and serotonin 5-HT1A/5-HT2A receptors (multi-target)
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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Upcoming events

(1 total)

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

2028 (1)
July 2028 (1)
Phase 3SchizophreniaNot yet recruiting
Est. primary completion 2028-07-31 · NCT07759869 · CT.gov ↗
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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.