Approval Probability
TA Base Rate
Adjusted LOA
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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, specifically major depressive disorder (MDD). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
TNX-601 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 drug's safety and efficacy in patients with major depressive disorder.
TNX-601 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received FDA approval for any indication.
TNX-601 has one completed Phase 2 clinical trial, registered as NCT05686408. This study evaluated TNX-601 ER monotherapy versus placebo in 132 patients with major depressive disorder in the United States. The trial enrolled adults aged 18 years and older.
TNX-601 ER is the extended-release formulation of TNX-601. The completed Phase 2 trial specifically evaluated TNX-601 ER monotherapy versus placebo in patients with major depressive disorder, indicating that the ER version is the form being tested in clinical development.