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Oxytocin

Phase 2

Oxidative Stress | Small molecule | Immunology |Cognition Therapeutics, Inc.|Last Updated: Apr 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Oxytocin · 2 trials · 3 indications

Phase 2 2
NCT04738838Oxytocin on Cold Water Task Performance and RecoveryCold Exposure
COMPLETED17 Analytics
NCT04732247Oxytocin for Oxidative Stress and InflammationOxidative Stress
COMPLETED40 Analytics
PHASE2COMPLETED
Oxytocin on Cold Water Task Performance and Recovery
Cold ExposureUnlock trial analytics
PHASE2COMPLETED
Oxytocin for Oxidative Stress and Inflammation
Oxidative StressUnlock trial analytics

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.

Change in muscle oxidative stress via glutathione reductase activity
Change in muscle glutathione reductase activity from before to 3 hours after the resistance swim + hyperoxia

Change in muscle glutathione reductase enzyme activity assessed by measuring muscle tissue levels of the reduced product, glutathione (GSH)

Change in blood oxidative stress via glutathione reductase activity
Change in blood glutathione reductase activity from before to 3 hours after the resistance swim + hyperoxia

Change in blood glutathione reductase enzyme activity assessed by measuring blood levels of the reduced product, glutathione (GSH)

Secondary Endpoints

Reduced rating of perceived exertion (RPE) during physical assessment post-cold water exposure
Within 3 hours post-treatment
Change in systemic inflammation via serum concentration of interleukin-6 (IL-6)
Change in serum IL-6 concentration from before to 3 hours after the resistance swim + hyperoxia
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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 to 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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Frequently asked questions about Oxytocin

What is Oxytocin used for?

Oxytocin is being studied for use in oxidative stress, inflammation, and cold exposure. It is an investigational small molecule in Phase 2 clinical development, evaluated in healthy male volunteers in the United States.

Who makes Oxytocin?

Oxytocin is being developed by Cognition Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker CGTX. The company is conducting clinical trials to evaluate the drug's effects on oxidative stress, inflammation, and cold exposure.

What phase is Oxytocin in?

Oxytocin is in Phase 2 clinical development. It has completed two Phase 2 trials, one for oxidative stress and inflammation and another for cold exposure. The drug is investigational and not yet approved for any use.

What clinical trials is Oxytocin in?

Oxytocin has completed two Phase 2 trials. NCT04732247 studied oxidative stress and inflammation in 40 participants, and NCT04738838 studied cold water task performance and recovery in 17 participants. Both were randomized, double-blind, placebo-controlled trials in healthy male volunteers in the United States.

Is Oxytocin the same as other forms of oxytocin?

Oxytocin is a small molecule being developed by Cognition Therapeutics, Inc. for oxidative stress and cold exposure. It is distinct from other uses of oxytocin, such as labor induction, and is being investigated for different indications in clinical trials.