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 | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
Artesunate + Amodiaquine is a fixed-dose combination of two antimalarial drugs used to treat uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax. It is being developed by Sanofi and has been studied in Phase 3 clinical trials for these indications.
Artesunate + Amodiaquine is developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has conducted clinical trials to evaluate the safety and efficacy of this combination therapy for the treatment of malaria.
Artesunate + Amodiaquine has completed Phase 3 clinical trials for the treatment of uncomplicated malaria. It is an investigational drug and has not been approved by regulatory authorities. The completed trials include studies in patients with Plasmodium falciparum and Plasmodium vivax malaria.
Artesunate + Amodiaquine has been studied in three completed clinical trials. NCT00316329 was a Phase 3 trial in 1032 patients with uncomplicated Plasmodium falciparum malaria across Cameroon, Madagascar, Mali, and Senegal. NCT00386503 was a Phase 1 bioavailability study in 22 healthy male volunteers in France. NCT01378286 was a Phase 3 trial in 380 patients with Plasmodium vivax malaria in Brazil.
Artesunate + Amodiaquine is the drug combination evaluated in the ATAQ EASY trial, which is the clinical trial identified as NCT00316329. This trial assessed the fixed-dose combination of artesunate and amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria.