Drugs / Fexinidazole
Fexinidazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed human African trypanosomiasis 1 milestone | |||||
| Filed | EU (EMA) | — | human African trypanosomiasis | — | “Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness.” dndi.org ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | FEXINIDAZOLE | — | 2021-07-16 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05607173 | Jan → May 2023 | liver disorder | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01483170 | Sep → Dec 2011 | human African trypanosomiasis | Drugs for Neglected Diseases | Terminated | No outcome recorded |
| Phase 1 | NCT01340157 | Feb → Apr 2011 | — | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 1 | NCT00982904 | Sep 2009 → Sep 2010 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03587766 | Nov 2017 → Dec 2018 | Chagas disease | Drugs for Neglected Diseases | Completed | Missed primary |
| Phase 2 | NCT01980199 | Nov 2013 → Nov 2014 | visceral leishmaniasis | Drugs for Neglected Diseases | Terminated | No outcome recorded |
| Phase 2/34 trials · 3 met primary | ||||||
| Phase 2/3 | NCT03974178 | Sep 2019 → Nov 2021 | infection by Trypanosoma rhodesiense | Drugs for Neglected Diseases | Completed | Met primary |
| Phase 2/3 | NCT02184689 | May 2014 → Dec 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | Met primary |
| Phase 2/3 | NCT02169557 | Apr 2014 → Oct 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | Met primary |
| Phase 2/3 | NCT01685827 | Oct 2012 → Nov 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03025789 | Nov 2016 → Feb 2021 | infection by Trypanosoma gambiense | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02498782 Comparator | Jul 2014 → Sep 2015 | Chagas disease | Drugs for Neglected Diseases | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-05-13 | Drugs for Neglected Diseases | Regulatory First all-oral treatment for a rare but deadly strain of sleeping sickness now available and being used to treat patients in endemic countries in Africa dndi.org ↗
Ministries of Health in three African countries have approved the use of Fexinidazole Winthrop for T.b. rhodesiense sleeping sickness treatment. |
| 2024-07-01 | Drugs for Neglected Diseases | Regulatory WHO recommends first all-oral treatment for acute sleeping sickness found in Eastern and Southern Africa dndi.org ↗
The World Health Organization (WHO) has included Fexinidazole Winthrop as the first-choice treatment for the acute form of sleeping sickness in its latest Guidelines for the treatment of human African trypanosomiasis (HAT), updated on 28 June 2024. |
| 2023-12-15 | Sanofi | Regulatory Press Release: EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa sanofi.com ↗
Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness ( rhodesiense ). |
| 2023-12-15 | Drugs for Neglected Diseases | Regulatory EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa dndi.org ↗
Sanofi, DNDi, and the HAT-r-ACC consortium announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense). |
| 2021-07-19 | Sanofi | Regulatory Media Update: US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness sanofi.com ↗
The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg. |
| 2021-07-19 | Drugs for Neglected Diseases | Regulatory US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness dndi.org ↗
The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of sleeping sickness (human African trypanosomiasis). |
| 2019-01-29 | Drugs for Neglected Diseases | Regulatory Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of Congo | DNDi dndi.org ↗
Marketing authorization of fexinidazole for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT), more commonly known as sleeping sickness, has been granted in the Democratic Republic of Congo (DRC). |
| 2018-11-15 | Drugs for Neglected Diseases | Regulatory European Medicines Agency recommends fexinidazole, the first all-oral treatment for sleeping sickness | DNDi dndi.org ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of fexinidazole, the first all-oral treatment that has been shown to be efficacious for both stages of sleeping sickness. |
| 2018-01-30 | Drugs for Neglected Diseases | Regulatory Sanofi, DNDi seek European Medicines Agency review for sleeping sickness treatment | DNDi dndi.org ↗
Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness. |
| 2017-11-03 | Drugs for Neglected Diseases | Results Phase II/III studies show high efficacy and safety of fexinidazole, the first oral treatment for sleeping sickness | DNDi dndi.org ↗
Treatment success rates of 91.2% were measured for fexinidazole, with 97.6% for NECT, 18 months after the end of treatment. |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fexinidazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03587766 ↗ |
| Known as | Fexinidazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1631694 ↗ |
| Known as | HOE239 | “Fexinidazole (HOE239)” NCT05607173 ↗ |
| Modality | Small molecule | “Fexinidazole is a 2-5-nitroimidazole, formulated for oral administration” NCT01685827 ↗ |
| Route | Oral | “single and multiple oral administration of increasing doses of fexinidazole” NCT00982904 ↗ |