fexinidazole
Small moleculeapprovedOrphan Drug FDA
Approved
Jul 16, 2021
Fexinidazole is a medication used to treat African trypanosomiasis caused by Trypanosoma brucei gambiense. It is effective against both first and second stage disease. It is taken by mouth. — Wikipedia
Clinical trial activity
13 trials · 9 clinical orgs · 2 marketing orgs
Phase 1
5
Phase 2
4
Phase 3
5
Phase 4
0
Earliest trial started Sep 1, 2009 (NCT00982904)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
2020s
- Jul 16, 2021
Sanofi-Aventis — Earliest FDA Approval
- Jul 16, 2021
Sanofi — Marketing Organization
- Jul 16, 2021
Sanofi-Aventis — NDA Secondary Org
- Jul 16, 2021
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Cytotoxic
Nitro pro-drug that is reduced to form cytotoxic species
Potential in leishmaniasis and trypanosomiasis
- UnclearUnclear
Unclear unclear
Approval history
- approvedPriority reviewJul 16, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CSc1ccc(OCc2ncc([N+](=O)[O-])n2C)cc1- Mol. weight
- 279.32 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaFexinidazole ↗
- ChEMBLCHEMBL1631694 ↗
Also known as
- fexinidazole
- fexinidazole
- fexinidazole
- fexinidazole
- fexinidazole
- hoe 239
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05607173 | Phase 1 | Dec 31, 2022 | Sanofi |
| NCT03974178 | Phase 2/Phase 3 (Phase 3) | Jun 30, 2019 | Drugs for Neglected Diseases Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP), Makerere University |
| NCT03587766 | Phase 2 | Nov 13, 2017 | Drugs for Neglected Diseases Initiative, University of Barcelona |
| NCT03025789 | Phase 3 | Nov 1, 2016 | Drugs for Neglected Diseases Initiative, Sanofi |
| NCT02571062 | Phase 1 | Mar 1, 2015 | Drugs for Neglected Diseases Initiative |
| NCT02498782 | Phase 2 | Jul 1, 2014 | Drugs for Neglected Diseases Initiative, Oswaldo Cruz Foundation |
| NCT02184689 | Phase 2/Phase 3 (Phase 3) | May 1, 2014 | Drugs for Neglected Diseases Initiative |
| NCT02169557 | Phase 2/Phase 3 (Phase 3) | May 1, 2014 | Drugs for Neglected Diseases Initiative |
| NCT01980199 | Phase 2 | Nov 1, 2013 | Drugs for Neglected Diseases Initiative, University of Khartoum |
| NCT01685827 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2012 | Drugs for Neglected Diseases Initiative, HAT National Control Program in DRC |
| NCT01483170 | Phase 1 | Sep 1, 2011 | Drugs for Neglected Diseases Initiative, SGS Life Sciences |
| NCT01340157 | Phase 1 | Feb 1, 2011 | Drugs for Neglected Diseases Initiative, Sanofi, SGS Life Sciences |
| NCT00982904 | Phase 1 | Sep 1, 2009 | Drugs for Neglected Diseases Initiative, Sanofi, SGS Life Sciences |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Drugs for Neglected Diseases Initiative | Academic/Hospital | 12 | 12 | 3 | 2009 |
| Sanofi | For profit | 4 | 1 | 2 | 2009 |
| SGS Life Sciences | For profit | 3 | 0 | 1 | 2009 |
| European and Developing Countries Clinical Trials Partnership (EDCTP) | Academic/Hospital | 1 | 0 | 1 | 2019 |
| HAT National Control Program in DRC | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Makerere University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Oswaldo Cruz Foundation | Academic/Hospital | 1 | 0 | 1 | 2014 |
| University of Barcelona | Academic/Hospital | 1 | 0 | 1 | 2017 |
| University of Khartoum | Academic/Hospital | 1 | 0 | 1 | 2013 |
9 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi | For profit | MKTG | Jul 16, 2021 |
| Sanofi-Aventis | For profit | NDA2 | Jul 16, 2021 |
| Sanofi-Aventis | For profit | NDA | Jul 16, 2021 |