Drugs / tinidazole
tinidazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TINDAMAX | — | 2007-05-21 | fda.gov ↗ |
| Approved | US (FDA) | TINDAMAX | — | 2004-05-17 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05361369 | May 2022 | — | Exeltis Turkey | Completed | No outcome recorded |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT07088419 | Jul 2025 → Aug 2026 overdue | primary bacterial infectious disease, urethritis | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT00811096 | Nov 2008 → Jan 2009 | Plasmodium vivax malaria | Walter Reed Army Institute of Research (WRAIR) | Completed | Missed primary |
| Phase 2 | NCT00322465 | Nov 2006 → Apr 2009 | urethritis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT00324142 | — | bacterial vaginosis | Kaiser Permanente | Withdrawn | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00403364 | Jul 2003 → Feb 2006 | Helicobacter pylori infectious disease | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Completed | Met primary |
| Phase 38 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT06418945 | Aug 2024 → Dec 2026 expected | — | The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06056947 | Jul 2020 → May 2021 | bacterial vaginosis, trichomonal vulvovaginitis, vulvovaginal candidiasis | Ege University | Completed | No outcome recorded |
| Phase 3 | NCT01481844 | Nov 2011 → Dec 2014 | — | Soroka University Medical Center | Completed | Met primary |
| Phase 3 | NCT01544517 | Jan → May 2011 | Helicobacter pylori infectious disease | University of Campania Luigi Vanvitelli | Completed | No outcome recorded |
| Phase 3 | NCT00229216 | Jan 2005 → Jun 2007 | bacterial vaginosis | Mission Pharmacal | Completed | Met primary |
| Phase 3 | NCT00313131 | Jan 2004 → May 2005 | bacterial vaginosis, candidiasis | University of Sherbrooke | Completed | No outcome recorded |
| Phase 3 | NCT00132171 | Jan → Dec 2001 | Helicobacter pylori infectious disease, chronic gastritis, duodenal ulcer, dyspepsia +1 | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Completed | Met primary |
| Phase 3 | NCT00003617 | Mar 1995 → ? | gastric cancer | Lymphoma Trials Office | Unknown | Missed primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT07624422 | Nov 2026 → Dec 2027 expected | Helicobacter pylori infectious disease, gastritis, peptic ulcer disease | Damascus Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03839875 | Apr → Aug 2019 | bacterial vaginosis, trichomonal vulvovaginitis, vulvovaginal candidiasis | Exeltis Turkey | Completed | No outcome recorded |
| Phase 4 | NCT03565484 | Jan 2019 → May 2020 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT03658746 | Jan → Dec 2019 | Helicobacter pylori infectious disease | Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT03571230 | Jul 2018 → Dec 2019 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT03139253 | May → Jun 2017 | — | Yanqing Li | Unknown | No outcome recorded |
| Phase 4 | NCT02988089 | Apr → Sep 2017 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT02776371 | Sep 2016 → Jan 2018 | — | Shandong University | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 met primary | ||||||
| — | NCT05383521 | Dec 2025 | Trichomonas vaginitis urogenital infection | Shangrong Fan | Unknown | No outcome recorded |
| — | NCT05126121 | Nov 2021 → Jun 2022 | Helicobacter pylori infectious disease | Xiuli Zuo | Unknown | No outcome recorded |
| — | NCT05133193 | Nov 2021 → Jun 2022 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| — | NCT02648698 | Jan 2016 → Dec 2018 | chronic endometritis | Fu Xing Hospital, Capital Medical University | Completed | Met primary |
| — | NCT01070277 | Mar 2012 → Dec 2015 | chronic diarrheal disease, gas bloat syndrome | Sheba Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 0 | NCT00510614 Comparator | Oct 2007 → Sep 2009 | bacterial vaginosis | University of Pittsburgh | Completed | No outcome recorded |
| Phase 3 | NCT04652284 Comparator | May 2021 → May 2023 | Helicobacter pylori infectious disease, bacterial gastritis, primary bacterial infectious disease | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT05863858 Comparator | Jun 2020 → Dec 2021 | Helicobacter pylori infectious disease | Iyad Naeem Muhammad, PhD | Completed | No outcome recorded |
| Phase 4 | NCT04122287 Comparator | Nov 2019 → Oct 2022 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04264663 Comparator | Nov 2019 → Oct 2022 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04348786 Background | Feb 2019 → Aug 2020 | Helicobacter pylori infectious disease | Damascus Hospital | Completed | Missed primary |
| Phase 4 | NCT04132479 Comparator | Jan → Dec 2018 | Helicobacter pylori infectious disease | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT03021590 Background | Jun 2017 → Dec 2021 | Helicobacter pylori infectious disease | Damascus Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02942485 Comparator | Dec 2016 → Dec 2019 | giardiasis | Helsinki University Central Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00334633 Comparator | Nov 2004 → Dec 2009 | bacterial vaginosis | University of Alabama at Birmingham | Completed | No outcome recorded |
| — | NCT03412071 Comparator | Dec 2017 → Dec 2019 | — | University of Toronto | Unknown | No outcome recorded |
| — | NCT00787553 Comparator | Jul 2006 → Dec 2008 | — | University of Campinas, Brazil | Unknown | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tinidazole | “Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid,...” NCT03565484 ↗38“The study drug, EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine.” NCT05361369 ↗ “EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)” NCT06056947 ↗ “which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks)” PMID 34218802 ↗ Jul 2021 “H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.” NCT02776371 ↗ “Antibiotics are selected from Amoxicillin, Tetracycline, Furazolidone, Levofloxacin, Clarithromycin, Tinidazole, Metronidazole.” NCT05133193 ↗ “levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks” NCT07624422 ↗ “followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg) twice daily for the remaining 5 days” PMID 12641522 ↗ Mar 2003 “Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group” NCT02648698 ↗ “tioconazole, tinidazole, lidocaine” NCT03839875 ↗ “Tinidazole 500 mg Tablets” NCT03021590 ↗ |
| Known as | CP-12574 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Fasigin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Fasigyn | “Patients from group 1 will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose.” NCT02942485 ↗ |
| Known as | Haisigyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | NSC-758189 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Simplotan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Symplotan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Tindamax | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Tinidazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Tricolam | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Known as | Trimonase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1220 ↗ |
| Action | Inhibit | “the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria” NCT06418945 ↗ |
| Modality | Small molecule | “Tinidazole is a second-generation nitroimidazole” NCT00229216 ↗ |
| Route | Oral | “tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days” PMID 17666604 ↗ Aug 2007 |