Clinical TrialJun 29, 2026, 07:11 AM
Tonix Pharmaceuticals Enrolls First Patient in Phase 2 MDD Study
AI Summary
Tonix Pharmaceuticals announced the enrollment of the first participant in HORIZON, a potentially pivotal Phase 2 study for TNX-102 SL 5.6 mg. This study evaluates the drug as a first-line monotherapy for adults with major depressive disorder (MDD). The randomized, double-blind, placebo-controlled trial expects to enroll approximately 360 patients, with the primary endpoint being the change in MADRS total score at Week 6. TNX-102 SL is already FDA-approved for fibromyalgia under the brand name TONMYA®.
Key Highlights
- First participant enrolled in HORIZON, a Phase 2 study for TNX-102 SL in Major Depressive Disorder (MDD).
- HORIZON is a potentially pivotal, randomized, double-blind, placebo-controlled study.
- Study evaluates TNX-102 SL 5.6 mg as a first-line monotherapy in adults with MDD.
- Primary endpoint is change from baseline in MADRS total score at Week 6.
- Approximately 360 patients are expected to enroll at 30 sites across the U.S.
- TNX-102 SL (TONMYA®) was FDA-approved for fibromyalgia in August 2025.
- Patents for TNX-102 SL provide U.S. market exclusivity until 2034, with potential extension to 2044.
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