Drugs / Malarone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MALARONE PEDIATRIC | — | 2000-07-14 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT03991208 | May 2019 → May 2021 | — | Walter Reed Army Institute of Research (WRAIR) | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00298610 Background | Mar 2006 → Oct 2007 | malaria | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| — | NCT01422954 Background | Jan → Dec 2012 | Plasmodium falciparum malaria | Radboud University Medical Center | Completed | No outcome recorded |
| — | NCT01236612 Background | Apr 2011 → Jun 2012 | Plasmodium falciparum malaria | Radboud University Medical Center | Completed | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Malarone | “Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.” NCT00298610 ↗ |