Tonix Pharma receives FDA IND clearance for TNX-102 SL Phase 2 MDD study

Tonix Pharmaceuticals Holding Corp.

FDA cleared IND for TNX-102 SL (cyclobenzaprine HCl) 5.6 mg sublingual tablets to treat major depressive disorder in adults.
Potentially pivotal Phase 2 HORIZON study: 6-week, randomized, double-blind, placebo-controlled, 360 patients at ~30 U.S. sites.
Primary endpoint: MADRS total score change from baseline at Week 6; enrollment to begin mid-2026.
TNX-102 SL targets disrupted sleep associated with MDD; prior fibromyalgia and PTSD studies showed depression symptom improvements.

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