Approval Probability
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Also known as Artemether-lumefantrine (COA566), COA566
Artemether-lumefantrine · 3 trials · 4 indications
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Artemether-lumefantrine |
| Cohort 1 | EXPERIMENTAL | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days. |
| Name | Type | Description |
|---|---|---|
| Artemether-lumefantrine | DRUG | - |
| Artemether-lumefantrine (COA566) | DRUG | One dispersible tablet taken orally twice a day during 3 days. |
Inclusion Criteria: * male or female infants and children ≤12 years of age * body weight of ≥5 kg and \<35 kg, * with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite Exclusion Criteria: * complicated malaria * persistent vomiting * malaria due to parasites othe...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
Artemether-lumefantrine is used to treat acute uncomplicated falciparum malaria and Plasmodium falciparum malaria. It is an antimalarial therapy developed by Novartis AG (ticker: NVS) and is being studied in infants and children, including those under 5 kg, in malaria-endemic regions of Africa.
Artemether-lumefantrine is developed by Novartis AG, which trades under the ticker NVS. Novartis has conducted clinical trials of the therapy in multiple African countries, including Benin, Burkina Faso, Kenya, Mali, Mozambique, Nigeria, Tanzania, Togo, and the Republic of the Congo.
Artemether-lumefantrine is in Phase 2 clinical development. A Phase 2 trial has been completed, and additional Phase 3 trials have also been completed. The drug remains investigational and is not approved based on the available development information.
Artemether-lumefantrine has been evaluated in completed clinical trials including NCT01619878, a Phase 2 study of a dispersible tablet in infants under 5 kg, and NCT00709969 and NCT00386763, both Phase 3 trials in African infants and children with uncomplicated P. falciparum malaria.
Yes, artemether-lumefantrine is also known as COA566. Both names refer to the same antimalarial therapy developed by Novartis AG for acute uncomplicated falciparum malaria and Plasmodium falciparum malaria.