Drugs / Acoziborole
Acoziborole
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05947604 | Feb → May 2023 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 1 | NCT04270981 | Feb → Jul 2020 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 1 | NCT01533961 | Feb 2012 → Mar 2015 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05433350 | Jul 2022 → Mar 2026 | infection by Trypanosoma gambiense | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2/3 | NCT05256017 | Dec 2021 → Aug 2023 | infection by Trypanosoma gambiense | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2/3 | NCT03087955 | Oct 2016 → Sep 2020 | infection by Trypanosoma gambiense | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06356974 | Apr 2024 → Dec 2026 expected | human African trypanosomiasis | Drugs for Neglected Diseases | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | Drugs for Neglected Diseases | Regulatory DRC approves the use of acoziborole, a breakthrough one-day oral treatment against sleeping sickness dndi.org ↗
The Democratic Republic of the Congo (DRC) has approved the use of Acoziborole Winthrop (acoziborole) as a single-dose oral treatment for both early- and advanced-stage gambiense sleeping sickness in adults and adolescents 12 years and older weighing at least 40 kilograms. |
| 2026-02-27 | Drugs for Neglected Diseases | Regulatory Acoziborole Winthrop, developed by DNDi and Sanofi, receives European Medicines Agency positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness dndi.org ↗
A positive CHMP opinion through the EU-M4all procedure provides a strong endorsement that the medicine meets EU standards. |
| 2022-11-29 | Drugs for Neglected Diseases | Results Acoziborole: Investigational single-dose oral treatment raises hope for elimination of sleeping sickness in Africa dndi.org ↗
The Drugs for Neglected Diseases initiative (DNDi) and Sanofi announce treatment success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole, a potentially transformative investigational treatment for sleeping sickness, published today in The Lancet Infectious Diseases medical journal. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | Drugs for Neglected Diseases | DRC approves the use of acoziborole, a breakthrough one-day oral treatment against sleeping sickness dndi.org ↗ |
| 2026-02-27 | Drugs for Neglected Diseases | Acoziborole Winthrop, developed by DNDi and Sanofi, receives European Medicines Agency positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness dndi.org ↗ |
| 2022-11-29 | Drugs for Neglected Diseases | Acoziborole: Investigational single-dose oral treatment raises hope for elimination of sleeping sickness in Africa dndi.org ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acoziborole | “Subjects agreeing to participate in the study and matching the inclusion/exclusion criteria will receive acoziborole 960 or 640 mg in a single intake at study day 1.” NCT06356974 ↗6“Acoziborole is a novel boron-containing candidate developed as an oral drug for the treatment of human African trypanosomiasis (HAT).” PMID 36763327 ↗ Feb 2023 |
| Known as | Acoziborol | ChEMBL registry synonym — accepted as the source's own label CHEMBL2347704 ↗ |
| Known as | Sctx-7158 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2347704 ↗ |
| Known as | SCYX-7158 | “Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense” NCT03087955 ↗ |
| Modality | Small molecule | — CHEMBL2347704 ↗ |
| Route | Oral | “single oral administration” NCT01533961 ↗ |