Drugs / Eurartesim
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Eurartesim | — | 2011-10-27 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01222949 | Feb → Jul 2010 | Plasmodium falciparum malaria | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT01103830 | Feb → Aug 2010 | Plasmodium falciparum malaria | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02110784 | Jun 2014 → Nov 2016 | Plasmodium vivax malaria | Alfasigma S.p.A. | Terminated | No outcome recorded Stop: Enrollment |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eurartesim | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01103830 ↗ |
| Route | Oral | “Multiple Oral Doses of Eurartesim on the QT/QTc Interval” NCT01103830 ↗ |