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ALTO-207

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment178
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07553637ALTO-207 in Adults With Treatment-resistant Depression (TRD)PHASE2 RECRUITING 178May 1, 2026Dec 1, 2027Apr 28, 202648 United States, United Kingdom
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07553637primaryCompletionDate: changed
LOWMay 24, 2026NCT07553637studyFirstPostDate: changed
LOWMay 21, 2026NCT07553637NEW_TRIAL: changed
LOWMay 21, 2026NCT07553637NEW_TRIAL: changed