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nitazoxanide

Trade name: Alinia

Small moleculeapprovedCOVID-19Orphan Drug FDA

Approved

Nov 22, 2002

Nitazoxanide, sold under the brand name Alinia among others, is a broad-spectrum antiparasitic and broad-spectrum antiviral medication that is used in medicine for the treatment of various helminthic, protozoal, and viral infections. It is indicated for the treatment of infection by Cryptosporidium parvum and Giardia lamblia in immunocompetent individuals and has been repurposed for the treatment of influenza. Nitazoxanide has also been shown to have in vitro antiparasitic activity and clinical treatment efficacy for infections caused by other protozoa and helminths; evidence as of 2014 suggested that it possesses efficacy in treating a number of viral infections as well. — Wikipedia

Clinical trial activity

111 trials · 168 clinical orgs · 4 marketing orgs

Phase 1
10
Phase 2
67
Phase 3
46
Phase 4
9

Earliest trial started Oct 1, 1995 (NCT00002444)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

  2. Dec 12, 1996

    Orphan Drug Designation

  3. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Romark — Earliest Phase 3 Sponsor(trial)

  2. Nov 22, 2002

    Romark — Earliest FDA Approval

  3. Nov 22, 2002

    Romark — NDA Organization

2020s

  1. Nov 27, 2020

    Rising Pharmaceuticals — Marketing Organization

  2. Feb 3, 2025

    Ani Pharmaceuticals — Marketing Organization

  3. Apr 15, 2025

    Annora Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 22, 2002

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)Oc1ccccc1C(=O)Nc1ncc([N+](=O)[O-])s1
Mol. weight
307.29 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 2-(acetolyloxy)-n-(5-nitro-2-thiazolyl)benzamide
  • adrovet
  • adrovet
  • alinia
  • alinia
  • alinia
  • alinia
  • colufase
  • columbia brand 1 of nitazoxanide
  • columbia brand 2 of nitazoxanide
  • columbia brand 3 of nitazoxanide
  • cryptaz
  • daxon
  • heliton
  • nitaxozanid
  • nitaxozanid
  • nitaxozanide
  • nitaxozanide
  • nitazode
  • nitazoxanida
  • nitazoxanida
  • nitazoxanida
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanide
  • nitazoxanidum
  • nitazoxanidum
  • nizonide
  • nodik
  • nodik
  • ntz
  • omniparax
  • omniparax
  • ph-5776
  • ph-5776
  • romark brand 1 of nitazoxanide
  • romark brand 2 of nitazoxanide
  • taenitaz
  • xerovirinc

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07110441Phase 1Aug 26, 2025Genfit
NCT07010744N/AJun 30, 2025Dhaka Medical College
NCT06993974Phase 2May 30, 2025Alexandria University, Kafrelsheikh University
NCT06817096Phase 3Feb 28, 2025Azidus, Farmoquimica S.A.
NCT07086937N/AJan 1, 2025RESnTEC, Institute of Research, Ziauddin University
NCT06600711Phase 3Nov 30, 2024Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID)
NCT06560853N/AFeb 27, 2024Medical Research Council, Stellenbosch University, United States Agency for International Development, University of London, University of Virginia
NCT07312721Phase 4Jan 5, 2024Shahida Islam Medical Complex
NCT06010992Phase 2Oct 1, 2023Menoufia University, Tanta University
NCT05897034Phase 2/Phase 3 (Phase 3)Jun 20, 2023Horus University, Tanta University
NCT06049901Phase 3Mar 1, 2023Tanta University
NCT05648422N/AJan 16, 2023Anahuac University
NCT05480878Phase 3Dec 2, 2022Tanta University
NCT05453916Phase 1/Phase 2 (Phase 2)Jul 1, 2022Sadat City University
NCT05368935Phase 1Apr 25, 2022Genfit
NCT05157269Phase 3Jan 31, 2022Romark
NCT05157243Phase 3Jan 31, 2022Romark
NCT05116826Phase 1Nov 5, 2021Genfit
NCT04918927Phase 2Oct 12, 2021Government of Mexico, Hakken Enterprise, Instituto Mexicano del Seguro Social, National Polytechnic Institute, Mexico, Siegfried, Strides Pharma Science, Universidad Autonoma De Guadalajara, Mexico, University of London
NCT04920838Phase 2/Phase 3 (Phase 3)Apr 12, 2021Alliance for International Medical Action, Centre Muraz, Government of France, Institut National de la Santé Et de la Recherche Médicale, France, Programme PACCI Abidjan, University of Barcelona, University of Bordeaux
Showing 20 of 111 trials
Page 1 / 6

Organizations

Research & Development (168)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RomarkFor profit292931999
Tanta UniversityAcademic/Hospital201732005
Alexandria UniversityAcademic/Hospital7222004
Cairo UniversityAcademic/Hospital6132005
National Institute of Allergy and Infectious Diseases (NIAID)Government6521999
AzidusFor profit5532020
Department of Veteran AffairsGovernment5122004
Farmoquimica S.A.For profit5032020
Cornell UniversityAcademic/Hospital3112007
GenfitFor profit3312021
Mansoura UniversityAcademic/Hospital3212018
National Institutes of Health (NIH)Government3122003
University of LiverpoolAcademic/Hospital3122020
University of VirginiaAcademic/Hospital3022017
Al Azhar UniversityAcademic/Hospital2022014
Anahuac UniversityAcademic/Hospital2212015
Assiut UniversityAcademic/Hospital2122018
ATCGenFor profit2012020
Atlanta Gastroenterology AssociatesAcademic/Hospital2012007
Baylor UniversityAcademic/Hospital2022004
168 organizations
Page 1 / 9

Marketing (4)

OrganizationOrg typeRelationshipDate
Ani PharmaceuticalsFor profitMKTGFeb 3, 2025
Annora PharmaFor profitMKTGApr 15, 2025
Rising PharmaceuticalsFor profitMKTGNov 27, 2020
RomarkFor profitNDANov 22, 2002