tinidazole

Trade name: tindamax

Small moleculeapprovedOrphan Drug FDA

Approved

May 17, 2004

Tinidazole is a synthetic antiprotozoal agent, formally known as 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole and a second-generation 2-methyl-5-nitroimidazole. Tinidazole is a prodrug and antiprotozoal agent. The nitro group of tinidazole is reduced in Trichomonas by a ferredoxin-mediated electron transport system. The free nitro radical generated as a result of this reduction is believed to be responsible for the antiprotozoal activity. It is suggested that the toxic free radicals covalently bind to DNA, causing DNA damage and leading to cell death. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known. Tindamax oral tablets are indicated for the treatment of trichomoniasis caused by T. vaginalis in both female and male patients assuming the organism has been identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection. Tindamax oral tablets are also indicated for the treatment of giardiasis caused by G. duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age. Another indication for Tindamax oral tablets is the treatment of intestinal amebiasis and amebic liver abscess caused by E. histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage. The most common side effects reported with tinidazole are upset stomach, bitter taste and itchiness. Other side effects include headache, physical fatigue, and dizziness. Anecdotally, people who have taken both metronidazole and tinidazole report toxicity is much the same except the side effects don't last as long with the latter. Drinking alcohol while taking tinidazole causes an unpleasant disulfiram-like reaction which includes nausea, vomiting, headache, increased blood pressure, flushing, and shortness of breath. — NCATS

Clinical trial activity

34 trials · 38 clinical orgs · 9 marketing orgs

Phase 1
3
Phase 2
12
Phase 3
8
Phase 4
13

Earliest trial started Mar 1, 1995 (NCT00003617)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Apr 18, 2002

    Orphan Drug Designation

  2. May 17, 2004

    Presutti Laboratories — Earliest FDA Approval

  3. May 17, 2004

    Presutti Laboratories — NDA Organization

  4. May 17, 2004

    Mission Pharmacal — NDA Secondary Org

  5. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 30, 2012

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  2. Apr 30, 2012

    West-Ward Pharmaceutical — Marketing Organization

  3. Apr 30, 2012

    Hikma — Marketing Organization

  4. Apr 30, 2012

    Chartwell Pharmaceuticals — Marketing Organization

  5. Oct 9, 2013

    Unique Pharmaceuticals Ltd, India — Marketing Organization

  6. Oct 9, 2013

    THINQ Pharma CRO Ltd. — Marketing Organization

  7. Aug 4, 2015

    Edenbridge Pharms — Marketing Organization

Indications

Mechanism of action

  • DNADISRUPTING AGENT

    DNA disrupting agent

  • DNADISRUPTING AGENT

    DNA disrupting agent

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedMay 17, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CCS(=O)(=O)CCN1C(C)=NC=C1[N+]([O-])=O
Mol. weight
247.272 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

Black box warning

Sources

Also known as

  • cp-12574
  • cp-12574
  • fasigyn
  • fasigyn
  • symplotan
  • timidazole
  • timidazole
  • tindamax
  • tindamax
  • tindamax
  • tindamax
  • tindamax
  • tindamax
  • tindamax
  • tinidazol
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • tinidazole
  • trimonase
  • trimonase
  • trimonase

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07088419Phase 2Jul 23, 2025Hologic, Inc., University of Washington
NCT06418945Phase 3Aug 1, 2024Henan Medical University
NCT05383521N/ADec 1, 2022Peking University
NCT05361369Phase 1May 9, 2022Exeltis, MonitorCRO
NCT05126121N/ANov 20, 2021Shandong University
NCT04652284Phase 3Feb 1, 2021Tel Aviv University
NCT06056947Phase 3Jul 20, 2020Ege University, Exeltis, MonitorCRO
NCT04264663Phase 4Nov 1, 2019Shandong University
NCT04122287Phase 4Oct 1, 2019Shandong University
NCT03839875Phase 4Apr 30, 2019Exeltis, MonitorCRO
NCT03658746Phase 4Oct 1, 2018Shandong University
NCT03565484Phase 4Aug 1, 2018Shandong University
NCT03571230Phase 4Jul 1, 2018Shandong University
NCT04132479Phase 4Jan 1, 2018University of Medicine 2, University of New South Wales
NCT03412071N/ADec 7, 2017Entebbe General Hospital, Medical Research Council-UVRI Uganda Research Unit on AIDS, University of Toronto
NCT02942485Phase 4Dec 1, 2017University of Helsinki
NCT03139253Phase 4May 30, 2017Shandong University
NCT02988089Phase 4Apr 20, 2017Binzhou Medical University, Liaocheng People's Hospital, People's Liberation Army of China, Shandong Provincial Hospital, Shandong University
NCT02711176Phase 4Sep 1, 2016Ilam University of Medical Sciences
NCT02648698N/AJan 1, 2016Capital Medical University
Showing 20 of 34 trials
Page 1 / 2

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Shandong UniversityAcademic/Hospital9922013
ExeltisFor profit3232019
MonitorCROFor profit3032019
Mission PharmacalFor profit2122005
National Institute of Allergy and Infectious Diseases (NIAID)Government2122004
Tel Aviv UniversityAcademic/Hospital2222012
Ben Gurion UniversityAcademic/Hospital1112011
Binzhou Medical UniversityAcademic/Hospital1012017
Canadian International Development AgencyAcademic/Hospital1012004
Capital Medical UniversityAcademic/Hospital1112016
Ege UniversityAcademic/Hospital1112020
Entebbe General HospitalAcademic/Hospital1012017
Henan Medical UniversityAcademic/Hospital1112024
Hologic, Inc.For profit1012025
Ilam University of Medical SciencesAcademic/Hospital1112016
Kaiser PermanenteAcademic/Hospital1112006
Liaocheng People's HospitalAcademic/Hospital1012017
Malaria Research Unit, ThailandAcademic/Hospital1012008
Medical Research Council-UVRI Uganda Research Unit on AIDSAcademic/Hospital1012017
National Cancer Institute (NCI)Government1111995
38 organizations
Page 1 / 2

Marketing (11)

OrganizationOrg typeRelationshipDate
Chartwell PharmaceuticalsFor profitMKTGApr 30, 2012
Edenbridge PharmsFor profitMKTGAug 4, 2015
HikmaFor profitMKTGApr 30, 2012
HikmaFor profitSYNApr 30, 2012
Mission PharmacalFor profitNDA2May 17, 2004
Novel Anti-Infective Technologies, LLCFor profitMKTGApr 30, 2012
Presutti LaboratoriesFor profitNDAMay 17, 2004
THINQ Pharma CRO Ltd.For profitMKTGOct 9, 2013
Unique Pharmaceuticals Ltd, IndiaFor profitMKTGOct 9, 2013
Unique Pharmaceuticals Ltd, IndiaFor profitSYNOct 9, 2013
West-Ward PharmaceuticalFor profitMKTGApr 30, 2012