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Fexinidazole (FEXINIDAZOLE)
Fexinidazole works by releasing free radicals that damage the DNA of Trypanosoma brucei gambiense, ultimately killing the parasite.
Fexinidazole, marketed by Sanofi, is an oral treatment for Human African Trypanosomiasis (HAT), a disease caused by Trypanosoma brucei gambiense. Its key strength lies in its mechanism of action, which involves releasing free radicals to damage the parasite's DNA, offering a targeted approach to treating HAT. The primary risk is the upcoming patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | FEXINIDAZOLE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Nitroimidazole Antimicrobial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Fexinidazole is an antiprotozoal drug [see Microbiology (12.4)].
Approved indications
- Human African Trypanosomiasis (HAT)
- Severe Second Stage HAT
Common side effects
- Vomiting
- Nausea
- Asthenia
- Headache
- Decreased appetite
- Insomnia
- Dizziness
- Hypocalcemia
- Dyspepsia
- Back pain
- Tremor
- Upper abdominal pain
Drug interactions
- Herbal Medicines and Supplements
- Drugs that May Prolong the QT Interval and/or Induce Bradycardia (e.g., antiarrhythmics, neuroleptics, fluoroquinolones, imidazole and triazole antifungals, pentamidine, antimalarials, phenothiazines, tricyclic antidepressants, terfenadine, astemizole, IV erythromycin, quinolone antibacterial drugs, β-blockers)
- Drugs Metabolized by Cytochrome P450 (CYP) 3A4/5 (e.g., lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives)
- Drugs Metabolized by CYP1A2 (e.g., duloxetine, tacrine, tizanidine, theophylline)
- Drugs Metabolized by CYP2C19 (e.g., lansoprazole, mephenytoin, diazepam)
- Drugs Metabolized by CYP2B6 (e.g., bupropion, efavirenz)
Key clinical trials
- A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment (PHASE1)
- Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense (PHASE2,PHASE3)
- Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage (PHASE3)
- Screen and Treat Implementation for HAT Control
- Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease (PHASE2)
- 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 (PHASE2,PHASE3)
- 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 (PHASE2,PHASE3)
- Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 (PHASE2,PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fexinidazole CI brief — competitive landscape report
- Fexinidazole updates RSS · CI watch RSS
- Sanofi portfolio CI