Drugs / Fexinidazole
Fexinidazole
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FEXINIDAZOLE | — | 2021-07-16 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2 | NCT03587766 | Nov 2017 → Dec 2018 | Chagas disease | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2 | NCT01980199 | Nov 2013 → Nov 2014 | visceral leishmaniasis | Drugs for Neglected Diseases | Terminated | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT03974178 | Sep 2019 → Nov 2021 | infection by Trypanosoma rhodesiense | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2/3 | NCT02184689 | May 2014 → Dec 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2/3 | NCT02169557 | Apr 2014 → Oct 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02498782 Comparator | Jul 2014 → Sep 2015 | Chagas disease | Drugs for Neglected Diseases | Unknown | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-12-15 | Sanofi | 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 ↗ |
| 2021-07-19 | Sanofi | Media Update: US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness sanofi.com ↗ |
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 NCT01483170 ↗ |
| 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 ↗ |