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Also known as Intranasal Oxytocin (IN-OXT)
Intranasal Oxytocin · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Part A Arm 1 | EXPERIMENTAL | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo |
| Part A Arm 2 | EXPERIMENTAL | Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 3 | EXPERIMENTAL | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo |
| Part A Arm 4 | EXPERIMENTAL | Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin |
| Part A Arm 5 | EXPERIMENTAL | Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 6 | EXPERIMENTAL | Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin |
| Part B Arm 1 | ACTIVE_COMPARATOR | Intranasal oxytocin 6 IU three times a day for 14 days |
| Part B Arm 2 | EXPERIMENTAL | Intranasal placebo three times a day for 14 days |
| Name | Type | Description |
|---|---|---|
| Intranasal Oxytocin (IN-OXT) | DRUG | 6 IU single dose |
| Placebo | DRUG | Intranasal placebo three times a day for 2 weeks |
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...
Intranasal Oxytocin is being studied for the treatment of vasopressin deficiency, a condition also known as arginine-vasopressin deficiency. It is administered as a nasal spray and is currently in Phase 1 clinical development. The drug is being evaluated for its effects in patients with this condition.
Intranasal Oxytocin is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TNXP. The company is conducting clinical trials to evaluate the safety and efficacy of this intranasal formulation of oxytocin for vasopressin deficiency.
Intranasal Oxytocin is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 clinical trial is actively recruiting participants to study its effects in patients with vasopressin deficiency.
Intranasal Oxytocin is being studied in a Phase 1 clinical trial with the identifier NCT04789148, titled 'Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency.' The trial is recruiting 40 participants in the United States and is randomized, double-blind, and active-controlled.
Yes, Intranasal Oxytocin is also known as IN-OXT, which stands for intranasal oxytocin. This abbreviation is used in clinical research to refer to the same drug formulation being developed by Tonix Pharmaceuticals for the treatment of vasopressin deficiency.
Intranasal Oxytocin works by delivering oxytocin, a peptide hormone, through the nasal route. Oxytocin is structurally similar to vasopressin and may compensate for the deficiency of vasopressin in patients with vasopressin deficiency. The intranasal administration allows for direct delivery to the central nervous system.