Recruiting
Phase 2

TNX-102 SL

Sponsor:

Tonix Pharmaceuticals, Inc.

Code:

NCT07621237

Conditions

Major Depressive Episode (MDE)

Major Depressive Disorder (MDD)

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TNX-102 SL

Placebo sublingual tablet

Study Details

Brief 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

Conditions

Major Depressive Episode (MDE)

Major Depressive Disorder (MDD)

Depression

Study ID

NCT07621237

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary DSM-5 diagnosis of current MDD.
  • The duration of the current MDE must be between 6 weeks and 18 months.
  • Without psychotic or catatonic features.
  • Capable of reading and understanding English and able to provide written informed consent to participate.

Exclusion Criteria:

  • Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa,
  • Diagnosis of borderline personality disorder that is known, suspected
  • Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD.
  • Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.
  • History of substance use disorder and/or alcohol use disorder during the preceding 12 months
  • Use of antidepressants (including ketamine/esketamine, St. John's Wort, S-adenosyl methionine, and/or trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TNX-102 SL

Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

placebo comparator: Placebo sublingual tablets

Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Interventions

TNX-102 SL

Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

Placebo sublingual tablet

Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Primary outcome measure

  • Change from Baseline (Visit 2) in the MADRS total score at Week 6. [ Time Frame: From Day 1 to Week 6 ]

Central Contacts and Locations

Central contacts

Timothy Roush

(862) 799-8599timothy.roush@tonixpharma.com

Locations

Clinical Neuroscience Solutions Inc. - Orlando

Recruiting

Orlando, Florida, United States, 32801

Delricht Research - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70115

More Information

Sponsor

Tonix Pharmaceuticals, Inc.

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Depression
  • TNX-102 SL
  • Cyclobenzaprine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc. on 2026-06-02.