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Intranasal Oxytocin

Phase 1

Vasopressin Deficiency | Small molecule | Other |Tonix Pharmaceuticals Holding Corp.|Last Updated: Sep 16, 2025

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04789148Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin DeficiencyPHASE1 RECRUITING 40 — — Sep 10, 2025Jun 1, 2026Sep 16, 20251 United States
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Study Endpoints
Primary Endpoints
Dot-probe task - anxious behavior between low dose oxytocin and placebo
20 minutes following intervention at each main visit

Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 6 IU oxytocin vs placebo in the dot-probe task.

Secondary Endpoints
Dot-probe task - anxious behavior between all three interventions
20 minutes following intervention
Depressive behavior - probabilistic reward task between all three interventions
30 minutes following intervention at each main visit
Socioemotional functioning - Emotion recognition task between all three interventions
40 minutes following intervention at each main visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A Arm 1EXPERIMENTALMain visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
Part A Arm 2EXPERIMENTALMain visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
Part A Arm 3EXPERIMENTALMain visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo
Part A Arm 4EXPERIMENTALMain visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin
Part A Arm 5EXPERIMENTALMain visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Part A Arm 6EXPERIMENTALMain visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin
Part B Arm 1ACTIVE_COMPARATORIntranasal oxytocin 6 IU three times a day for 14 days
Part B Arm 2EXPERIMENTALIntranasal placebo three times a day for 14 days
Interventions
NameTypeDescription
Intranasal Oxytocin (IN-OXT)DRUG6 IU single dose
PlaceboDRUGIntranasal placebo three times a day for 2 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18 and above * Arginine-vasopressin deficiency * Normal FT4 or T4 * Normal serum/plasma sodium * Stable hormone replacement Exclusion Criteria: * Active substance use disorder within the last 6 months * History of psychosis * Suicidal behavior and/or active suicidal idea...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04789148studyFirstPostDate: changed