Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-1900 · 1 trial · 4 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.
| 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. |
| 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. |
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 an investigational small molecule being developed for the treatment of chronic migraine. It is intended for patients with chronic migraine, including those with or without aura. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TNX-1900 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 TNX-1900 for chronic migraine.
TNX-1900 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not received FDA approval and is not yet available for commercial use.
TNX-1900 has one completed Phase 2 clinical trial, identified as NCT05679908. This study evaluated the efficacy and safety of TNX-1900 in patients with chronic migraine. The trial enrolled 88 participants and was conducted in the United States.
TNX-1900 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval for the treatment of chronic migraine.