Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intranasal Oxytocin (IN-OXT), TNX-1900
Intranasal Oxytocin · 2 trials · 5 indications
Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.
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 |
|---|---|---|
| TNX-1900 High Dose | EXPERIMENTAL | 30 IU oxytocin taken intranasally twice daily. |
| TNX-1900 Low Dose | EXPERIMENTAL | 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. |
| Placebo | PLACEBO_COMPARATOR | Placebo taken intranasally twice daily. |
| 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 |
|---|---|---|
| TNX-1900 | DRUG | Patients will spray TNX-1900 once into each nostril. |
| Placebo Nasal Spray | DRUG | Patients will spray placebo nasal spray once into each nostril. |
| Intranasal Oxytocin (IN-OXT) | DRUG | 6 IU single dose |
| Placebo | DRUG | Intranasal placebo three times a day for 2 weeks |
Major Inclusion Criteria: * Men and women aged 18 to 65 years, inclusive, at the time of Visit 1. * History of migraine with or without aura for at least 1 year and onset at \< 50 years of age. Patient must also have a history of chronic migraine \> 3 months prior to Visit 1 as defined by IHS ICHD-...
Intranasal Oxytocin is being studied for use in Vasopressin Deficiency, a condition also known as arginine-vasopressin deficiency. It is an investigational small molecule being developed by Tonix Pharmaceuticals Holding Corp. (TNXP) and is currently in Phase 1 clinical development.
Intranasal Oxytocin targets the oxytocin receptor (OXTR). It is being investigated for its potential effects in patients with Vasopressin Deficiency, also called arginine-vasopressin deficiency. The drug is administered intranasally and is currently in Phase 1 clinical trials.
Intranasal Oxytocin is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TNXP. The drug is currently in Phase 1 clinical development for the treatment of Vasopressin Deficiency.
Intranasal Oxytocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients with Vasopressin Deficiency in the United States.
Intranasal Oxytocin is being studied in one active Phase 1 clinical trial with the identifier NCT04789148. The trial is titled 'Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency' and is recruiting 40 participants in the United States. It is a randomized, double-blind, active-controlled study.
Yes, Intranasal Oxytocin is also known as IN-OXT. This alternative name is used in clinical research and literature to refer to the same investigational drug being developed by Tonix Pharmaceuticals for Vasopressin Deficiency.