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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: 11 Sep 2019

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At a glance

  • Originator Romark Laboratories
  • Developer Chugai Pharmaceutical; Romark Laboratories
  • Class Amides; Anthelmintics; Antidiarrhoeals; Antifibrotics; Antiprotozoals; Antivirals; Benzamides; Nitro compounds; Phenylacetates; Small molecules; Thiazoles
  • Mechanism of Action EIF-2 kinase modulators; HN protein inhibitors; Oxidoreductase inhibitors; Receptor protein-tyrosine kinase modulators
  • Orphan Drug Status

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

    Yes - Amoebiasis; Giardiasis; Cryptosporidiosis
  • 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 Hepatitis B; Respiratory syncytial virus infections
  • Suspended Hepatitis C
  • No development reported Crohn's disease; Rotavirus infections
  • Discontinued Clostridium difficile infections

Most Recent Events

  • 01 Sep 2019 Phase-II clinical trials in Hepatitis B (Treatment-experienced) in Singapore (PO)
  • 05 Apr 2019 Romark Laboratories plans a phase II trial for Hepatitis B (Treatment-experienced) in June 2019 , (NCT03905655)
  • 26 Mar 2019 Romark Laboratories completes a phase III trial in Influenza virus infections (In adolescents, In adults, In the elderly) in USA, Australia and Puerto Rico (NCT3336619)
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