TINIDAZOLE · CHARTWELL RX
Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis Giardiasis: in patients age 3 and older Amebiasis: in patients age 3 and older Bacterial Vaginosis: in non-pregnant, adult women To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Trichomonas vaginalis .
Details
- Status
- Prescription
- First Approved
- 2004-05-17
- Routes
- ORAL
- Dosage Forms
- TABLET
TINIDAZOLE Approval History
What TINIDAZOLE Treats
4 indicationsTINIDAZOLE is approved for 4 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Trichomoniasis
- Giardiasis
- Amebiasis
- Bacterial Vaginosis
TINIDAZOLE Boxed Warning
POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology (13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use. [see Warnings and Precautions(5.1) ]. WARNING: POT...
WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology (13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use. [see Warnings and Precautions(5.1) ]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole tablets to approved indications only (1.1, 1.2, 1.3). Avoid chronic use. (5.1)
TINIDAZOLE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TINIDAZOLE
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07088419 SHAZAM | STUDY00021780 None, N/A | Ph 2 | recruiting | "Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)" |
| NCT02942485 results posted | PGLIT2016 | Ph 4 | terminated | Treatment of Giardia Lamblia Infections in Children |
| NCT01591889 | TINI-T500-PVFD-1 | Ph 1 | completed | Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions |
| NCT00811096 | 1477 HRPO Log#(A-15176);, Mahidol (TMEC 08-042) | Ph 2 | completed | Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TINIDAZOLE FDA Label Details
Indications & Usage
FDA Label (PDF)Tinidazole is a nitroimidazole antimicrobial indicated for: Trichomoniasis Giardiasis: in patients age 3 and older Amebiasis: in patients age 3 and older Bacterial Vaginosis: in non-pregnant, adult women To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole tablets and other antibacterial drugs, tinidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis . The organism...
WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology (13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and h...
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TINDAMAX
Full clinical data, patents, trials, and competitive landscape for tinidazole.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.