TINDAMAX (tinidazole) · MISSION PHARMA
Tindamax (tinidazole) is a nitroimidazole antimicrobial indicated for the treatment of trichomoniasis, where simultaneous treatment of sexual partners is recommended to prevent re-infection. It is indicated for the treatment of giardiasis and specific forms of amebiasis (intestinal amebiasis and amebic liver abscess) in both adults and pediatric patients older than three years of age; however, it is not indicated for asymptomatic cyst passage. Additionally, Tindamax is used to treat bacterial vaginosis in adult women. To maintain effectiveness and reduce the development of drug-resistant bacteria, it should only be used for infections proven or strongly suspected to be caused by susceptible organisms.
How TINDAMAX Works
Tinidazole is a nitroimidazole antiprotozoal and antibacterial agent. It works by diffusing into the microbial cell, where the nitro group is reduced by a cell-mediated mechanism. The resulting chemically reactive intermediates and free radicals cause DNA strand breakage and inhibit DNA synthesis, leading to the death of susceptible protozoa and bacteria.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-05-17
- Routes
- ORAL
- Dosage Forms
- TABLET
TINDAMAX Approval History
What TINDAMAX Treats
5 indicationsTINDAMAX is approved for 5 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Trichomoniasis
- Giardiasis
- Amebiasis
- Amebic Liver Abscess
- Bacterial Vaginosis
TINDAMAX Boxed Warning
POTENTIAL RISK FOR CARCINOGENICITY 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. Its use should be reserved for the conditions described in INDICATIONS AND USAGE ( 1 ). WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicit...
WARNING: POTENTIAL RISK FOR CARCINOGENICITY 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. Its use should be reserved for the conditions described in INDICATIONS AND USAGE ( 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. Use should be limited to approved indications only.
TINDAMAX 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.
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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.
TINDAMAX FDA Label Details
Indications & Usage
FDA Label (PDF)1 INDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be 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 [see Clinical Studies ]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three...
WARNING: POTENTIAL RISK FOR CARCINOGENICITY 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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment