Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
Artemether-lumefantrine is used for the treatment of malaria, specifically acute uncomplicated falciparum malaria caused by Plasmodium falciparum. It is being developed by Novartis AG for infectious disease indications including malaria and Plasmodium falciparum malaria.
Artemether-lumefantrine is a small molecule combination therapy that targets the malaria parasite Plasmodium falciparum. It is used to treat acute uncomplicated falciparum malaria by acting against the parasite that causes the infection.
Artemether-lumefantrine is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is being investigated for the treatment of malaria and related Plasmodium falciparum infections.
Artemether-lumefantrine is in Phase 2 clinical development for acute uncomplicated falciparum malaria. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for this Phase 2 study.
Artemether-lumefantrine has been studied in clinical trials including NCT00386763, a Phase 3 study in children with uncomplicated falciparum malaria, and NCT01619878, a Phase 2 trial in infants weighing less than 5 kg with acute uncomplicated falciparum malaria.
Artemether-lumefantrine is a fixed-dose combination of artemether and lumefantrine. It is known by the brand name Coartem, which is a widely used antimalarial medication. The drug is being studied for use in pediatric populations with malaria.