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ALTO-101

Phase 2

Schizophrenia | Small molecule | Neurology |Alto Neuroscience, Inc.|Last Updated: Dec 26, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment82
FDA Designations
FAST_TRACK
Clinical trial landscape

ALTO-101 · 1 trial · 2 indications

Phase 2 1
NCT06502964Study of ALTO-101 in Patients With SchizophreniaSchizophrenia
RECRUITING82 Analytics
PHASE2RECRUITING
Study of ALTO-101 in Patients With Schizophrenia
Schizophrenia
NCT0650296482
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Study Endpoints
Primary Endpoints
Theta band activity
Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11

Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.

Secondary Endpoints
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Treatment Period Day 1 through study completion (an average of 36 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALTO-101EXPERIMENTAL10 days administration of ALTO-101T transdermal delivery system
PlaceboPLACEBO_COMPARATOR10 days administration of placebo transdermal delivery system
Interventions
NameTypeDescription
ALTO-101DRUGALTO-101 patches
ALTO-101 Transdermal Delivery SystemDEVICEALTO-101 transdermal delivery system
PlaceboDRUGInactive placebo patches
Placebo Transdermal Delivery SystemDEVICEPlacebo transdermal delivery system
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Eligibility Criteria
Age Range21 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Schizophrenia diagnosis for at least one year * Cognitive impairment * Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2 * Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening * Have a bod...

Countries:United States
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Competitive Landscape -Schizophrenia 37 trials
CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1N/AUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06502964primaryCompletionDate: changed
LOWMay 24, 2026NCT06502964studyFirstPostDate: changed