Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as intranasal oxytocin
TNX-1900 · 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-...
TNX-1900 is being developed for the treatment of chronic migraine. It is a small molecule therapeutic candidate from Tonix Pharmaceuticals. The drug has been studied in a Phase 2 clinical trial in patients with chronic migraine.
TNX-1900 targets oxytocin, a hormone. By interacting with oxytocin, the drug is designed to modulate pathways involved in migraine. This mechanism is being explored for the management of chronic migraine.
TNX-1900 is being developed by Tonix Pharmaceuticals Holding Corp., which trades on the Nasdaq under the ticker symbol TNXP. The company is focused on central nervous system disorders and is advancing TNX-1900 for chronic migraine.
TNX-1900 is in Phase 2 clinical development for chronic migraine. The Phase 2 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.
TNX-1900 has been evaluated in a Phase 2 clinical trial, NCT05679908, titled "A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine." The trial was completed and enrolled 88 patients in the United States.