FEXINIDAZOLE
Fexinidazole is a nitroimidazole antimicrobial that treats human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. It helps patients 6 years of age and older who weigh at least 20 kg, addressing both the early hemolymphatic stage and the later meningoencephalitic stage of the disease. Because the drug shows decreased efficacy in patients with severe second-stage disease, it is used in those specific cases only when no other treatment options are available.
How FEXINIDAZOLE Works
This medication works as an antiprotozoal agent to target the parasites responsible for the infection. As a nitroimidazole antimicrobial, it acts against the protozoa to help clear the disease from the patient's system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-07-16
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
FEXINIDAZOLE Approval History
What FEXINIDAZOLE Treats
1 indicationsFEXINIDAZOLE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human African Trypanosomiasis
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03974178 results posted | DNDi-FEX-07-HAT | Ph 2, Ph 3 | completed | Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense |
| NCT03025789 results posted | DNDi-FEX-09-HAT | Ph 3 | completed | Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage |
| NCT03587766 FEXI12 | DNDi-FEX-12-CH 2016-004905-15 | Ph 2 | completed | Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease |
| NCT02184689 | DNDiHATFEX006 | Ph 2, Ph 3 | completed | Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study |
| NCT02169557 | DNDiHATFEX005 | Ph 2, Ph 3 | completed | Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study |
| NCT01685827 | DNDiFEX004 | Ph 2, Ph 3 | completed | Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 |
| NCT01340157 | DNDiFEX002 | Ph 1 | completed | Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions |
| NCT01980199 | FEXI VL 001 | Ph 2 | terminated | Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan |
| NCT02571062 | DNDiHATFEX008 | Ph 1 | completed | Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation |
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.
FEXINIDAZOLE FDA Label Details
Indications & Usage
FDA Label (PDF)FEXINIDAZOLE is indicated for the treatment of Human African Trypanosomiasis.
FEXINIDAZOLE Patents & Exclusivity
Exclusivity
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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