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Oxytocin

Phase 3

Pain | Small molecule | Other |Tonix Pharmaceuticals Holding Corp.|Trials Updated: Jul 28, 2026

Development status

Highest phase Phase 3 run by University Hospitals Cleveland Medical Center (NCT03138252)
Phase scored for TNXPPhase 2
Registered trials 16 across 8 sponsors since Nov 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

Oxytocin · 1 trial · 2 indications

Phase 2 1
NCT07730294Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary SurgeryPain
NOT YET_RECRUITING75 Analytics
PHASE2NOT YET_RECRUITING
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
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Study Endpoints

Primary Endpoints

Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
Pre-op up to 8 weeks after last drug administration

The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).

Change in post-operative pain measured by monitoring of pain medication usage
Pre-op up to 8 weeks after last drug administration

Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay.

Secondary Endpoints

Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)
Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)
Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7
Pre-op up to 8 weeks after last drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low Dose OxytocinEXPERIMENTALParticipants in this arm will receive low dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
High Dose OxytocinEXPERIMENTALParticipants in this arm will receive high dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
Saline-Mg solutionPLACEBO_COMPARATORParticipants in this arm will receive placebo beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.

Interventions

NameTypeDescription
Oxytocin (Low dose)DRUGThe dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
Oxytocin (High dose)DRUGThe dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
Placebo (saline)DRUGPlacebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age: Between 30 to 75 years old. * Consent: Ability to give informed consent. * Language: Proficiency in the English language. * Medical Condition: Diagnosed with a pituitary lesion requiring surgery. * Menopausal Status: Post-menopause for women (at least 1 year since last me...

Countries:United States
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