Trial Profile

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

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 17 Nov 2025

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At a glance

17 Nov 2025 New trial record
10 Nov 2025 According to a Tonix Pharmaceuticals media release, company intends to initiate the study mid-year 2026.
18 Sep 2025 According to a Tonix Pharmaceuticals media release, company announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with FDA regarding the development of TNX-102 SL for major depressive disorder. Company received positive feedback from the FDA and plans to pursue sNDA to expand the therapeutic indication in MDD. An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter.

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