A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
← catalyst calendarNCT07621237 · readout ≤ 559 d
Sponsored by Tonix Pharmaceuticals, Inc. (industry) · TNXP — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
360estimated
Sites
25
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jun 2026 | estimated | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Major Depressive Episode (MDE)
- Major Depressive Disorder (MDD)
- Depression
Interventions
- Drug: TNX-102 SL — also filed as cyclobenzaprine, cyclobenzaprine HCl
- Drug: Placebo sublingual tablet
Primary outcome
what the primary-completion date above is the date OFChange from Baseline (Visit 2) in the MADRS total score at Week 6.
measured From Day 1 to Week 6
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