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ALTO-207

Phase 2

Treatment-resistant Depression (TRD) | Small molecule | Psychiatry |Alto Neuroscience, Inc.|Last Updated: Apr 28, 2026

Target and mechanism

Molecular targetDopamine D3 receptor
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

ALTO-207 · 1 trial · 1 indication

Phase 2 1
NCT07553637ALTO-207 in Adults With Treatment-resistant Depression (TRD)Treatment-resistant Depression (TRD)
RECRUITING178 Analytics
PHASE2RECRUITING
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Treatment-resistant Depression (TRD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in the MADRS total score
Change from baseline up to 8 weeks

Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Secondary Endpoints

Change in response (≥50% improvement) raters based on MADRS
Change from baseline up to 8 weeks
Change in the Clinician-administered CGI-S score over time from Baseline to Week 8
Change from baseline up to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALTO-207EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALTO-207DRUGALTO-207 BID
PlaceboDRUGMatching Placebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF. * Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe). * Failure to respond (\<50% improveme...

Countries:United StatesUnited Kingdom
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Frequently asked questions about ALTO-207

What is ALTO-207 used for?

ALTO-207 is an investigational small molecule being developed for the treatment of treatment-resistant depression (TRD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does ALTO-207 target?

ALTO-207 targets the dopamine D3 receptor, a type of receptor involved in the central nervous system. By modulating this receptor, the drug aims to address symptoms of treatment-resistant depression, though its exact mechanism of action is still under investigation.

Who makes ALTO-207?

ALTO-207 is being developed by Alto Neuroscience, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ANRO.

What phase is ALTO-207 in?

ALTO-207 is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA or any other regulatory agency.

What clinical trials is ALTO-207 in?

ALTO-207 is being studied in a Phase 2 clinical trial with the identifier NCT07553637. This trial is recruiting participants with treatment-resistant depression and is expected to enroll 178 patients across the United States and United Kingdom.

Is ALTO-207 the same as any other drug?

No alternative names for ALTO-207 have been reported. It is a distinct investigational compound developed by Alto Neuroscience, Inc. for the treatment of treatment-resistant depression.