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Fexinidazole FDA Approval History

Last updated by Judith Stewart, BPharm on July 21, 2021.

FDA Approved: Yes (First approved July 16, 2021)
Generic name: fexinidazole
Dosage form: Tablets
Company: Drugs for Neglected Diseases Initiative
Treatment for: Trypanosomiasis

Fexinidazole is a nitroimidazole antibacterial indicated for the treatment of human African trypanosomiasis (African sleeping sickness) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

  • Human African trypanosomiasis an infection caused by the protozoa Trypanosoma brucei gambiense which is transmitted by the bite of an infected tsetse fly. Fexinidazole works by inhibiting protozoal DNA synthesis.
  • Fexinidazole is approved for both the first-stage (hemolymphatic) and the second-stage (meningoencephalitic) of human African trypanosomiasis.
  • Fexinidazole tablets are taken orally once daily with food, for 10 days. Patients taking fexinidazole should not consume alcoholic beverages during treatment, and for at least 48 hours after completing the course of therapy.
  • Patients should contact their healthcare provider immediately if they experience neuropsychiatric adverse reactions, such as insomnia, headache, tremor, mood changes, psychiatric disorders, and suicidal ideation.
  • Common adverse reactions include headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.

Development timeline for fexinidazole

Jul 19, 2021Approval FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.