Drugs / Coartem
Coartem
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COARTEM | — | 2009-04-07 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable1 trial | ||||||
| — | NCT02528279 | Oct 2014 → Oct 2016 | malaria | Albert Schweitzer Hospital | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT02942277 Background | Oct 2016 → Jul 2020 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 1 | NCT01103830 Comparator | Feb → Aug 2010 | Plasmodium falciparum malaria | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 1/2 | NCT03952650 Background | May 2019 → Feb 2021 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05750628 Comparator | Jan 2024 → Jun 2026 overdue | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT04546633 Comparator | Feb 2021 → Aug 2024 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03334747 Comparator | Nov 2017 → Nov 2019 | malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03167242 Comparator | Aug 2017 → Jun 2021 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05842954 Comparator | Mar 2024 → Jun 2025 | Plasmodium falciparum malaria | Novartis Pharmaceuticals | Completed | Met primary |
| — | NCT00513500 Comparator | Jun 2007 → Feb 2009 | malaria, pneumonia | Boston University | Completed | Met primary |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-24 | Novartis Pharmaceuticals | Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants novartis.com ↗ |
| 2015-07-16 | Novartis Pharmaceuticals | Novartis malaria treatment Coartem® 80/480mg receives WHO prequalification, enabling greater access for patients novartis.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Coartem | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05842954 ↗ |
| Known as | artemether-lumefantrine | “Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used...” NCT02942277 ↗1“Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days.” NCT02528279 ↗ |
| Known as | Coartem(R) | “Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used...” NCT02942277 ↗ |
| Known as | Riamet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01103830 ↗ |
| Route | Oral | “(Coartem®) orally as a 6 dose regimen for three consecutive days” NCT02528279 ↗ |