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Nitazoxanide - Romark Laboratories

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Drug Profile

Nitazoxanide - Romark Laboratories

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: 13 Oct 2024

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At a glance

  • Originator Romark Laboratories
  • Developer Chugai Pharmaceutical; Romark Laboratories
  • Class Amides; Anthelmintics; Anti-inflammatories; Antidiarrhoeals; Antifibrotics; Antiprotozoals; Antivirals; Benzamides; Hepatoprotectants; 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 - Cryptosporidiosis; Giardiasis; Amoebiasis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cryptosporidiosis; Giardiasis; Helminthiasis; Protozoan infections
  • Phase III COVID 2019 infections; 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

  • 24 Sep 2024 Romark Laboratories withdraws phase III trial prior to enrolment for COVID-2019 infections (In children, In adults, In the elderly) (PO, Controlled release) due to sponsor decision (NCT05157243)
  • 20 Sep 2024 Romark Laboratories withdraw phase III trial prior to enrolment for COVID-2019 infections (In children, In adults, In the elderly) (PO, Controlled release) due to sponsor decision (NCT05157269)
  • 21 Mar 2023 Coordinación de Investigación en Salud completes the phase IIa FANTAZE trial in COVID-2019 infections in Mexico (PO) (NCT04918927)

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