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Cyclobenzaprine hydrochloride very low dose - Tonix Pharmaceuticals

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Drug Profile

Cyclobenzaprine hydrochloride very low dose - Tonix Pharmaceuticals

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

Latest Information Update: 26 Mar 2025

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At a glance

  • Originator Vela Pharmaceuticals
  • Developer Tonix Pharmaceuticals Holding Corp; Tonix Pharmaceuticals Inc; University of North Carolina
  • Class Amines; Analgesics; Anxiolytics; Behavioural disorder therapies; Dibenzocycloheptenes; Drug withdrawal therapies; Muscle relaxants; 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

  • Preregistration Fibromyalgia
  • Phase III Post-traumatic stress disorders
  • Phase II Agitation; Post acute COVID 19 syndrome; Traumatic stress disorders
  • No development reported Alcoholism; Unspecified

Most Recent Events

  • 11 Mar 2025 Phase-II clinical trials in Traumatic stress disorders in USA (Sublingual) (NCT06636786)
  • 23 Dec 2024 The US FDA assigns PDUFA action date of 15/08/2025 for cyclobenzaprine hydrochloride very low dose for Fibromyalgia
  • 17 Dec 2024 The US FDA accepts NDA for cyclobenzaprine hydrochloride very low dose for Fibromyalgia for review

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