Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TNX-601 ER
TNX-601 · 1 trial · 6 indications
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
| Arm | Type | Description |
|---|---|---|
| TNX-601 ER, 39.4 mg | EXPERIMENTAL | 1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet taken orally once daily for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| TNX-601 ER | DRUG | Patients will take 1 tablet orally once daily for 6 weeks. |
| Placebo | DRUG | Patients will take 1 tablet orally once daily for 6 weeks. |
Inclusion Criteria: * Female or male aged 18 to 65 years (inclusive). * Have a primary DSM-5 diagnosis of current MDD. 1. The duration of the current MDE must be at least 12 weeks. 2. Without psychotic or catatonic features. Exclusion Criteria: * Psychiatric History: 1. Diagnosis of DSM-5...
TNX-601 is an investigational small molecule being developed for the treatment of depression, including major depressive disorder. It is in Phase 2 clinical development and is not approved for any indication. The completed Phase 2 trial evaluated TNX-601 ER as monotherapy in patients with major depressive disorder.
TNX-601 is being developed by Tonix Pharmaceuticals Holding Corp., which trades on the Nasdaq under the ticker TNXP. The company is the sponsor of the clinical program for TNX-601 ER in depression.
TNX-601 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
TNX-601 has been studied in a completed Phase 2 trial, NCT05686408, titled Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD). The trial enrolled 132 patients in the United States and was randomized, double-blind, and placebo-controlled.
Yes, TNX-601 ER is an alternative name for TNX-601. The ER designation refers to the extended-release formulation used in the Phase 2 trial NCT05686408, which evaluated TNX-601 ER monotherapy versus placebo in patients with major depressive disorder.