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ALTO-101

Phase 2

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

ALTO-101 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2024

ALTO-101 target and mechanism

Molecular targetPDE4
ModalitySmall molecule

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

ALTO-101 clinical trials

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
SchizophreniaUnlock trial analytics

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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Frequently asked questions about ALTO-101

What is ALTO-101 used for in schizophrenia?

ALTO-101 is an investigational small molecule being developed for the treatment of cognitive impairment associated with schizophrenia. It is currently in Phase 2 clinical development and has not been approved by the FDA.

What does ALTO-101 target?

ALTO-101 targets PDE4, an enzyme involved in intracellular signaling pathways. By inhibiting PDE4, the drug is designed to address cognitive deficits in schizophrenia. It is being studied in patients with schizophrenia and cognitive impairment.

Who makes ALTO-101?

ALTO-101 is being developed by Alto Neuroscience, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ANRO. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is ALTO-101 in?

ALTO-101 is in Phase 2 clinical development. It is an investigational drug that has not yet received FDA approval. The drug has been granted Fast Track designation by the FDA for its intended use in schizophrenia.

What clinical trials is ALTO-101 in?

ALTO-101 is being studied in a Phase 2 clinical trial registered as NCT06502964, titled 'Study of ALTO-101 in Patients With Schizophrenia.' This randomized, double-blind, placebo-controlled trial is recruiting 82 participants in the United States.

Is ALTO-101 the same as any other drug?

No alternative names for ALTO-101 have been reported. It is identified solely by its developmental code name ALTO-101 and is being investigated by Alto Neuroscience for cognitive impairment in schizophrenia.