Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Artesunate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Artesunate (Pfizer) | EXPERIMENTAL | - |
| Artesunate (Arsuamoon® Tablets Guilin-China) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Artesunate (Test) | DRUG | Oral tablet, single dose, 1 x 100 mg |
| Artesunate (Comparator) | DRUG | Oral tablet, single dose, 2 x 50 mg |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * BMI of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs). * An informed consent document signed and dated by the subject or a legally acceptable representative. Exclusion Criteria: *...
Artesunate is a small molecule being developed for the treatment of falciparum malaria, a severe form of malaria caused by the Plasmodium falciparum parasite. It is currently in Phase 1 clinical development as an investigational therapy for this infectious disease.
Artesunate is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for falciparum malaria.
Artesunate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for falciparum malaria.
Artesunate has one completed clinical trial, NCT00894374, a Phase 1 bioequivalence study comparing Artesunate tablets to Arsuamoon tablets in healthy subjects. The trial enrolled 40 participants in Singapore and was active-controlled, though it was not randomized or double-blinded.
Artesunate is not the same as Arsuamoon, but they were compared in a clinical trial. Arsuamoon is a reference product manufactured by Guilin Pharmaceutical in China, used as an active control in the bioequivalence study of Artesunate tablets.