Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Artesunate+ Amodiaquine · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| artesunate/amodiaquine | EXPERIMENTAL | artesunate (AS) / amodiaquine (AQ) as fixed dose combination 1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment |
| chloroquine | ACTIVE_COMPARATOR | 150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment |
| Name | Type | Description |
|---|---|---|
| ARTESUNATE + AMODIAQUINE | DRUG | Pharmaceutical form: Route of administration: |
| Chloroquine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: * Adults and children over 6 months old and bodyweight \> 5 kg * Able to be treated by oral route * Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days * Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100...
| 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 |
Artesunate + Amodiaquine is a combination antimalarial treatment used for uncomplicated malaria, including Plasmodium falciparum and Plasmodium vivax infections. It combines two small molecule drugs in a fixed dose regimen. Sanofi develops the combination, which has been studied in Phase 3 trials across Africa and Brazil.
Sanofi, which trades under the ticker SNY, is the developer of Artesunate + Amodiaquine. The company has sponsored clinical trials of the fixed dose combination for uncomplicated malaria, including studies in Cameroon, Madagascar, Mali, Senegal, and Brazil.
Artesunate + Amodiaquine has completed Phase 3 clinical development. Three trials are registered, all completed, with a total enrollment of 1,434 participants. The Phase 3 studies evaluated the combination in uncomplicated Plasmodium falciparum and Plasmodium vivax malaria.
Artesunate + Amodiaquine has been studied in three completed trials: NCT01378286, a Phase 3 study versus chloroquine in Brazil; NCT00386503, a Phase 1 bioavailability study in France; and NCT00316329, a Phase 3 trial in Cameroon, Madagascar, Mali, and Senegal.