Asset profile

NBI-1117568

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 2027-10.

NCT05545111: The study randomly assigned 210 participants to four NBI-1117568 dose groups or placebo and used quadruple masking of participants, care providers, investigators, and outcome assessors. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

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.

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Competitive landscape

62 competitors in this universe: 2 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
NBI-1117568: this drugPhase 3Small moleculeMuscarinic M4 receptor
EmraclidinePhase 2Small moleculeMuscarinic M4 receptor
NTX-253Phase 1Small moleculeMuscarinic M4 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)
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)

…and 47 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

(5 total)

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

2027 (2)
October 2027 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2027-10 · NCT06963034 · CT.gov ↗
What to watch
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November 2027 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2027-11 · NCT07105098 · CT.gov ↗
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2028 (1)
February 2028 (1)
Phase 2Bipolar I Disorder, ManiaRecruiting
Est. primary completion 2028-02 · NCT07288320 · CT.gov ↗
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2029 (1)
July 2029 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2029-07 · NCT07227818 · CT.gov ↗
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2031 (1)
December 2031 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2031-12 · NCT07114874 · 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 (4)
Phase 2 (2)