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 28 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00510614 Comparator | Oct 2007 → Sep 2009 | bacterial vaginosis | University of Pittsburgh | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| 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 47 trials | ||||||
| Phase 4 | NCT04264663 Comparator | Nov 2019 → Oct 2022 | Helicobacter pylori infectious disease | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04122287 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 | No outcome recorded |
| 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| Phase 4 | NCT03021590 Background | Jun 2017 → Dec 2021 | Helicobacter pylori infectious disease | Damascus Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT02942485 Comparator | Dec 2016 → Dec 2019 | giardiasis | Helsinki University Central Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00334633 Comparator | Nov 2004 → Dec 2009 | bacterial vaginosis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | 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 16 cited values
Every value below carries the sentence it was read from. 42 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 | Tinafas | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02711176 ↗ |
| 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 |