Asset profile

Olanzapine/samidorphan (Lybalvi)

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Schizophrenia

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

track record: Reliable signal

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Olanzapine / Samidorphan (Lybalvi): this drugApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist); mu-opioid receptor (antagonist)
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

(1 total)

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

2027 (1)
September 2027 (1)
Phase 3SchizophreniaEnrolling by invitation
Est. primary completion 2027-09 · NCT04987229 · 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.

Phase 3 (8)
Phase 2 (1)
Phase 1 (4)
Appears in other studies (1)