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Oxytocin

Phase 2

Cold Exposure | Small molecule | Other |Cognition Therapeutics, Inc.|Last Updated: Apr 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04738838Oxytocin on Cold Water Task Performance and RecoveryPHASE2 COMPLETED 17May 20, 2022Jul 29, 2022Apr 3, 20262 United States
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Study Endpoints
Primary Endpoints
Cognitive performance assessment score change (code substitution)
Within 3 hours post-treatment

Changes in code substitution scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time.

Cognitive performance assessment score change (reaction time)
Within 3 hours post-treatment

Changes in choice reaction time scores as measured by the Defense Automated Neurobehavioral Assessment (DANA). Data will be measured in milliseconds for response time.

Oculometric assessment score change (saccades)
Within 3 hours post-treatment

Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Saccades will be monitored and counted throughout the duration of the assessment.

Oculometric assessment score change (blink rate)
Within 3 hours post-treatment

Altered ocular response as measured by the I-Portal Portable Assessment System (i-PAS). Number of blinks will be counted through the course of the assessment.

Oculometric assessment score change (blink duration)
Within 3 hours post-treatment

Altered ocular response in blink duration as measured by the I-Portal Portable Assessment System (i-PAS). Blink duration will be measured in milliseconds.

Secondary Endpoints
Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure
Within 3 hours post-treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Oxytocin Nasal SprayEXPERIMENTALSingle dose of intranasal oxytocin (48 IU) prior to testing protocol.
Placebo Nasal SprayPLACEBO_COMPARATORSingle dose of intranasal treatment with placebo (identical to oxytocin nose spray minus the oxytocin)
Interventions
NameTypeDescription
Oxytocin nasal sprayDRUGIntranasal treatment with oxytocin via nasal spray (48 IU per dose)
Placebo nasal sprayDRUGIntranasal treatment with placebo via nasal spray
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Eligibility Criteria
Age Range18 Years — 39 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Recreationally skilled swimmers Exclusion Criteria: * Smoking/vaping, a history of psychiatric disorders, safety requirements related to the oxytocin administration \[hypersensitivity to oxytocin or vasopressin, history of hyponatremia, syndrome of inappropriate antidiuretic...

Countries:United States
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