Treats Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. Sold as Benznidazole. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Benznidazole (sold as Benznidazole), first approved Aug 29, 2017, with 0 new uses approved and 0 published complete response letters.
| A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.Chagas Disease · Novartis Pharmaceuticals | Phase 2 | Recruiting | Oct 9, 2024 |
| Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas DiseaseChagas Disease · Laboratorio Elea Phoenix S.A. | Phase 3 | Recruiting | May 21, 2021 |
| Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas DiseaseChagas Disease · Insud Pharma | Phase 3 | Active, not recruiting | Jul 18, 2019 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 29, 2017 | BenznidazoleNDA 209570 · New molecular entity | Chemo Research Sl | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
