Trial Profile

A Phase 2 clinical trial of Cyclobenzaprine hydrochloride in Major depressive disorder.

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 11 Dec 2025

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At a glance

Drugs Cyclobenzaprine (Primary)
Indications Major depressive disorder
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms HORIZON

Most Recent Events

24 Nov 2025 According to a Tonix Pharmaceuticals media release, company announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults.
24 Nov 2025 According to a Tonix Pharmaceuticals media release, company plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026
17 Nov 2025 New trial record

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