Oral anti-parasitic medical drug
Fexinidazole is a medication used to treat African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense .[ 3] It is effective against both first and second stage disease.[ 3] Also a potential new treatment for Chagas disease , a neglected tropical disease that affects millions of people worldwide.[ 4] It is taken by mouth.[ 5]
Common side effects include nausea, vomiting, headache, and trouble sleeping.[ 6] Other side effects may include QT prolongation , psychosis , and low white blood cells .[ 7] It is unclear if use during pregnancy or breast feeding is safe.[ 7] Fexinidazole is in the antiparasitic and the nitroimidazole family of medications.[ 5] It is believed to work by turning on certain enzymes within the parasites that result in their death.[ 6]
Fexinidazole was first described in 1978.[ 8] It was given a positive opinion by the European Medicines Agency in 2018.[ 6] It is on the World Health Organization's List of Essential Medicines .[ 9] [ 10] Development for sleeping sickness was funded by the Drugs for Neglected Diseases initiative in collaboration with Sanofi .[ 11] Fexinidazole was approved for medical use in the United States in July 2021.[ 1]
^ a b "Fexinidazole: FDA-Approved Drugs" . U.S. Food and Drug Administration . Retrieved 16 July 2021 .
^ "Fexinidazole tablet" . DailyMed . U.S. National Library of Medicine. Retrieved 20 August 2021 .
^ a b "Fexinidazole Winthrop H-W-2320" . European Medicines Agency . 22 January 2019. Archived from the original on 18 January 2021. Retrieved 12 November 2019 .
^ Torrico F, Gascón J, Ortiz L, Pinto J, Rojas G, Palacios A, et al. (February 2023). "A Phase 2, Randomized, Multicenter, Placebo-Controlled, Proof-of-Concept Trial of Oral Fexinidazole in Adults With Chronic Indeterminate Chagas Disease" . Clinical Infectious Diseases . 76 (3): e1186–e1194. doi :10.1093/cid/ciac579 . PMC 9907522 . PMID 35925555 .
^ a b Deeks ED (February 2019). "Fexinidazole: First Global Approval". Drugs . 79 (2): 215–220. doi :10.1007/s40265-019-1051-6 . PMID 30635838 . S2CID 57772417 .
^ a b c "Fexinidazole Winthrop (fexinidazole)" (PDF) . EMA . Archived from the original (PDF) on 2 January 2021. Retrieved 12 November 2019 .
^ a b "Fexinidazole Winthrop" (PDF) . EMA . Archived from the original (PDF) on 12 November 2019. Retrieved 12 November 2019 .
^ Mowbray CE (2017). "Antileishmanial Drug Discovery: Past, Present, and Future Perspectives" . In Gil C, Rivas L (eds.). Drug Discovery for Leishmaniasis . Royal Society of Chemistry. p. 30. ISBN 9781788012584 .
^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019 . Geneva: World Health Organization. hdl :10665/325771 . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021) . Geneva: World Health Organization. hdl :10665/345533 . WHO/MHP/HPS/EML/2021.02.
^ "Fexinidazole – DNDi" . www.dndi.org . 31 December 2004. Retrieved 12 November 2019 .