Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intranasal Oxytocin single dose · 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 | Part A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo |
| Part A Arm 2 | EXPERIMENTAL | Part A Main visit 1: 6 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 3 | EXPERIMENTAL | Part A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: intranasal placebo |
| Part A Arm 4 | EXPERIMENTAL | Part A Main visit 1: 24 IU intranasal oxytocin; Part A Main visit 2: intranasal placebo; Part A Main visit 3: 6 IU intranasal oxytocin |
| Part A Arm 5 | EXPERIMENTAL | Part A Main visit 1: intranasal placebo; Part A Main visit 2: 6 IU intranasal oxytocin; Part A Main visit 3: 24 IU intranasal oxytocin |
| Part A Arm 6 | EXPERIMENTAL | Part A Main visit 1: intranasal placebo; Part A Main visit 2: 24 IU intranasal oxytocin; Part A Main visit 3: 6 IU intranasal oxytocin |
| Part B Arm 1 | ACTIVE_COMPARATOR | Part B: Intranasal oxytocin 6 IU three times a day for 14 days |
| Part B Arm 2 | EXPERIMENTAL | Part B: Intranasal placebo three times a day for 14 days |
| Name | Type | Description |
|---|---|---|
| Intranasal Oxytocin (IN-OXT) 6 IU single dose | DRUG | Part A: 6 IU single dose |
| Intranasal Oxytocin (IN-OXT) 6 IU repeat dose | DRUG | Part B: IN-OXT 6 IU three times a day for 2 weeks |
| Placebo repeat dose | DRUG | Part B: Intranasal placebo three times a day for 2 weeks |
| Intranasal Oxytocin (IN-OXT) 24 IU single dose | DRUG | Part A: 24 IU single dose |
| Placebo single dose | DRUG | Part A: placebo single dose |
Inclusion Criteria: * Age 18 and above * Arginine-vasopressin deficiency * Normal FT4 * 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 ideation w...
Intranasal Oxytocin is an investigational small-molecule drug given as a single 6 IU intranasal dose being studied in adults with vasopressin deficiency. It is being developed by Tonix Pharmaceuticals Holding Corp. (ticker TNXP) and is currently in Phase 1 clinical development in the United States.
Intranasal Oxytocin is being studied for use in patients with vasopressin deficiency, also called arginine-vasopressin deficiency. The Phase 1 trial enrolls adults aged 18 years and older with this condition, and it is not open to healthy volunteers. The drug remains investigational and has not been established as a treatment.
Intranasal Oxytocin targets OXTR, the oxytocin receptor. By acting at this receptor, the intranasal formulation is designed to engage oxytocin signaling in patients with vasopressin deficiency. The Phase 1 program is testing a single 6 IU dose of the small-molecule drug.
Intranasal Oxytocin is being developed by Tonix Pharmaceuticals Holding Corp., which trades under the ticker TNXP. The company is running a Phase 1 study of a single 6 IU intranasal dose in adults with vasopressin deficiency in the United States.
Intranasal Oxytocin is in Phase 1 clinical development. It is an investigational drug and is not approved for any use. The single Phase 1 trial is currently recruiting participants, with a planned enrollment of 40 adults with vasopressin deficiency.
Intranasal Oxytocin is being studied in one Phase 1 trial, NCT04789148, titled Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency. The recruiting study enrolls 40 adults in the United States and is randomized, double-blind, and active-controlled.
Yes, IN-OXT is shorthand for Intranasal Oxytocin. The asset is also described as Intranasal Oxytocin (IN-OXT) 6 IU single dose or Intranasal Oxytocin single dose, referring to the same Phase 1 program from Tonix Pharmaceuticals in vasopressin deficiency.