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NCT07621237 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
A Phase 2 study, sponsored by Tonix Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
NCT07621237: Recruiting Phase 2 study, sponsored by Tonix Pharmaceuticals.
NCT07621237 is a Phase 2 study that is actively recruiting participants, run by Tonix Pharmaceuticals. The registered enrollment target is 360 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07621237, a Phase 2 study, is actively recruiting participants, sponsored by Tonix Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL? Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder. Participants will: Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests
Primary Outcome
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Interventions
- DRUG Placebo sublingual tablet
- DRUG TNX-102 SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT07621237 shows while recruiting
NCT07621237 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo sublingual tablet is the first listed.
NCT07621237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07621237 about?
NCT07621237 is a clinical study titled "A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)". The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depr...
What is the current status of trial NCT07621237?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2026-06. Estimated completion is 2028-02.
What interventions are being tested in trial NCT07621237?
The interventions under investigation include: Placebo sublingual tablet (DRUG), TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT07621237?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07621237's enrollment target sits among peer trials
360 123rd of 2000 higher than 1,874 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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