Nitazoxanide - Romark Laboratories/Chugai Pharmaceutical

Drug Profile

Nitazoxanide - Romark Laboratories/Chugai Pharmaceutical

Alternative Names: Alinia; Colufase; Cryptaz; Daxon; Nitazoxanide controlled-release tablets - Romark; Nitazoxanide CR 675mg tablets - Romark; NT-300; NT-675; NTZ; PH 5776; Tizoxanide

Latest Information Update: 18 Oct 2018

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At a glance

  • Originator Romark Laboratories
  • Developer Chugai Pharmaceutical; Romark Laboratories
  • Class Anthelmintics; Antidiarrhoeals; Antiprotozoals; Antivirals; Small molecules; Thiazoles
  • Mechanism of Action EIF-2 kinase modulators; HN protein inhibitors; Oxidoreductase inhibitors
  • Orphan Drug Status

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

    Yes - Cryptosporidiosis; Giardiasis; Amoebiasis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cryptosporidiosis; Giardiasis; Helminthiasis; Protozoan infections
  • Phase III Enterovirus infections; Influenza virus infections; Rhinovirus infections
  • Phase II/III Hepatic encephalopathy
  • Phase II Respiratory syncytial virus infections
  • Suspended Hepatitis C
  • No development reported Crohn's disease; Rotavirus infections
  • Discontinued Clostridium-difficile-infections

Most Recent Events

  • 11 Sep 2018 Phase-III clinical trials in Enterovirus infections in USA (PO) (NCT03605862)
  • 11 Sep 2018 Phase-III clinical trials in Rhinovirus infections in USA (PO) (NCT03605862)
  • 02 Aug 2018 Romark Laboratories plans a phase III trial for Common cold due to Enterovirus and/or rhinovirus infections (in children, in adolescents, and in adults)(NCT03605862)
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