BENZNIDAZOLE · CHEMO RESEARCH SL
Benznidazole is a nitroimidazole antimicrobial indicated for the treatment of Chagas disease (American trypanosomiasis) caused by *Trypanosoma cruzi* in pediatric patients aged 2 to 12 years. This indication was granted accelerated approval based on the percentage of treated patients who achieved negative Immunoglobulin G (IgG) antibody status against *T. cruzi* recombinant antigens. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
How BENZNIDAZOLE Works
Benznidazole is a nitroimidazole antimicrobial drug that targets the *Trypanosoma cruzi* parasite. Its antimicrobial activity leads to a reduction in the parasite load, which is clinically manifested by a decrease in and eventual disappearance of specific IgG antibodies produced by the host against *T. cruzi* antigens.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-08-29
- Routes
- ORAL
- Dosage Forms
- TABLET
BENZNIDAZOLE Approval History
What BENZNIDAZOLE Treats
2 indicationsBENZNIDAZOLE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chagas Disease
- American Trypanosomiasis
BENZNIDAZOLE 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
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04024163 | LPRI747-301 | Ph 3 | active not recruiting | Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease |
| NCT05523596 | ICM003 | Ph 1 | completed | A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults |
| NCT03672487 BETTY results posted | R01HD095857 | Ph 3 | completed | Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age |
| NCT06632600 | CLXE408B12201 | Ph 2 | recruiting | A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease. |
| NCT03981523 TESEO | 743474 U01AI129783 | Ph 2 | completed | New Therapies and Biomarkers for Chagas Infection |
| NCT03191162 MULTIBENZ | 2016-003789-21 | Ph 2 | completed | Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease. |
| NCT03892213 | DNDi-CH-E1224-002 | Ph 1 | completed | Pharmacokinetic Drug-Drug Interaction Study |
| NCT01377480 STOP CHAGAS results posted | P05267 MK-5592-055 | Ph 2 | completed | A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) |
| NCT01678599 PCR | MSF/DNDi-CD-PCR-01 | Ph 4 | completed | Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease |
| NCT01755403 CINEBENZ | CINEBENZ | Ph 4 | completed | Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease |
| NCT01162967 CHAGASAZOL | CHAGASAZOL01 | Ph 2 | completed | Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole |
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.
BENZNIDAZOLE FDA Label Details
Indications & Usage
FDA Label (PDF)Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi . This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Benznidazole Tablets, a nitroimidazole antimicrobial, is indicated in pediat...
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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