tinidazole
Trade name: tindamax
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
Earliest trial started Mar 1, 1995 (NCT00003617)
Timeline
1990s
- Jan 1, 1995
Earliest Phase 3 Sponsor(trial)
2000s
- Apr 18, 2002
Orphan Drug Designation
- May 17, 2004
Presutti Laboratories — Earliest FDA Approval
- May 17, 2004
Presutti Laboratories — NDA Organization
- May 17, 2004
Mission Pharmacal — NDA Secondary Org
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
2010s
- Apr 30, 2012
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Apr 30, 2012
West-Ward Pharmaceutical — Marketing Organization
- Apr 30, 2012
Hikma — Marketing Organization
- Apr 30, 2012
Chartwell Pharmaceuticals — Marketing Organization
- Oct 9, 2013
Unique Pharmaceuticals Ltd, India — Marketing Organization
- Oct 9, 2013
THINQ Pharma CRO Ltd. — Marketing Organization
- Aug 4, 2015
Edenbridge Pharms — Marketing Organization
Indications
Approved for
Studied for
- Bacterial Infections · Phase 4
- Biological Availability · Phase 1
- Candidiasis · Phase 3
- Drug Resistance, Bacterial · Phase 3
- Gastritis · Phase 3
- Giardiasis · Phase 4
- Gingival Diseases · Phase 3
- Helicobacter Infections · Phase 4
- Helicobacter pylori · Phase 4
- Malaria, Vivax · Phase 2
- Mycoplasma genitalium · Phase 2
- Stomach Neoplasms · Phase 3
- Trichomonas Infections · Phase 1
- Urethritis · Phase 2
- Vagina · Phase 4
- Vaginitis · Phase 4
- Vulvovaginitis · Phase 4
Mechanism of action
Approval history
- approvedMay 17, 2004
Chemistry & pharmacology
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
Sources
- WikipediaTinidazole ↗
- NCATS033KF7V46H ↗
- ChEMBLCHEMBL1220 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07088419 | Phase 2 | Jul 23, 2025 | Hologic, Inc., University of Washington |
| NCT06418945 | Phase 3 | Aug 1, 2024 | Henan Medical University |
| NCT05383521 | N/A | Dec 1, 2022 | Peking University |
| NCT05361369 | Phase 1 | May 9, 2022 | Exeltis, MonitorCRO |
| NCT05126121 | N/A | Nov 20, 2021 | Shandong University |
| NCT04652284 | Phase 3 | Feb 1, 2021 | Tel Aviv University |
| NCT06056947 | Phase 3 | Jul 20, 2020 | Ege University, Exeltis, MonitorCRO |
| NCT04264663 | Phase 4 | Nov 1, 2019 | Shandong University |
| NCT04122287 | Phase 4 | Oct 1, 2019 | Shandong University |
| NCT03839875 | Phase 4 | Apr 30, 2019 | Exeltis, MonitorCRO |
| NCT03658746 | Phase 4 | Oct 1, 2018 | Shandong University |
| NCT03565484 | Phase 4 | Aug 1, 2018 | Shandong University |
| NCT03571230 | Phase 4 | Jul 1, 2018 | Shandong University |
| NCT04132479 | Phase 4 | Jan 1, 2018 | University of Medicine 2, University of New South Wales |
| NCT03412071 | N/A | Dec 7, 2017 | Entebbe General Hospital, Medical Research Council-UVRI Uganda Research Unit on AIDS, University of Toronto |
| NCT02942485 | Phase 4 | Dec 1, 2017 | University of Helsinki |
| NCT03139253 | Phase 4 | May 30, 2017 | Shandong University |
| NCT02988089 | Phase 4 | Apr 20, 2017 | Binzhou Medical University, Liaocheng People's Hospital, People's Liberation Army of China, Shandong Provincial Hospital, Shandong University |
| NCT02711176 | Phase 4 | Sep 1, 2016 | Ilam University of Medical Sciences |
| NCT02648698 | N/A | Jan 1, 2016 | Capital Medical University |
Organizations
Research & Development (38)
Marketing (11)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Chartwell Pharmaceuticals | For profit | MKTG | Apr 30, 2012 |
| Edenbridge Pharms | For profit | MKTG | Aug 4, 2015 |
| Hikma | For profit | MKTG | Apr 30, 2012 |
| Hikma | For profit | SYN | Apr 30, 2012 |
| Mission Pharmacal | For profit | NDA2 | May 17, 2004 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Apr 30, 2012 |
| Presutti Laboratories | For profit | NDA | May 17, 2004 |
| THINQ Pharma CRO Ltd. | For profit | MKTG | Oct 9, 2013 |
| Unique Pharmaceuticals Ltd, India | For profit | MKTG | Oct 9, 2013 |
| Unique Pharmaceuticals Ltd, India | For profit | SYN | Oct 9, 2013 |
| West-Ward Pharmaceutical | For profit | MKTG | Apr 30, 2012 |