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Cyclobenzaprine hydrochloride - Tonix Pharmaceuticals

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Drug Profile

Cyclobenzaprine hydrochloride - Tonix Pharmaceuticals

Alternative Names: Cyclobenzaprine HCL - Tonix Pharmaceuticals; cyclobenzaprine HCl sublingual tablet - Tonix Pharmaceuticals; KRL-102; TNX-102; TNX-102 SL; TNX-102 SL1; Tonmya; VLD-cyclobenzaprine

Latest Information Update: 01 Dec 2025

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At a glance

  • Originator Vela Pharmaceuticals
  • Developer Tonix Pharmaceuticals Holding Corp; Tonix Pharmaceuticals Inc
  • Class Amines; Anxiolytics; Behavioural disorder therapies; Dibenzocycloheptenes; Drug withdrawal therapies; Muscle relaxants; Non-opioid analgesics; Small molecules
  • Mechanism of Action Alpha 1 adrenergic receptor antagonists; Histamine H1 receptor antagonists; Muscarinic M1 receptor antagonists; Serotonin 5-HT2A receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Fibromyalgia
  • Phase III Post-traumatic stress disorders
  • Phase II Acute traumatic stress disorders; Post acute COVID 19 syndrome
  • Preclinical Agitation; Alcoholism; Major depressive disorder

Most Recent Events

  • 24 Nov 2025 The US FDA approves IND application for cyclobenzaprine hydrochloride in Major depressive disorder
  • 24 Nov 2025 Tonix Pharmaceuticals Holding Corp plans the phase II HORIZON trial for Major depressive disorders in USA (Sublingual), in mid-year 2026
  • 17 Nov 2025 Launched for Fibromyalgia (In adults) in USA (Sublingual)

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