Recent Updates
Recently added Catalysts

Artesunate + Amodiaquine

Phase 3

Malaria | Small molecule | Infectious Disease |Sanofi|Last Updated: Jul 18, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,434
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01378286Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax MalariaPHASE3 COMPLETED 380 — — Jan 1, 2012Jun 1, 2013Jul 18, 20131 Brazil
NCT00316329ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum MalariaPHASE3 COMPLETED 1,032 — — Mar 1, 2006 -Apr 22, 20085 Cameroon, Madagascar +2
NCT00386503Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted ConditionsPHASE1 COMPLETED 22 — — Jun 1, 2006 -Dec 9, 20081 France
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
28 days
Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups
Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ
During all the study conduct
Tmax, Cmax, Truncated AUC(0-10d) for DSA
during the study conduct
Secondary Endpoints
Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28
up to a maximum of 42 days
Number of patients without parasite
up to a maximum of 42 days
Number of patients without fever
up to a maximum of 42 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
artesunate/amodiaquineEXPERIMENTALartesunate (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
chloroquineACTIVE_COMPARATOR150mg 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
Interventions
NameTypeDescription
ARTESUNATE + AMODIAQUINEDRUGPharmaceutical form: Route of administration:
ChloroquineDRUGPharmaceutical form:tablet Route of administration: oral
Unlock Study Design Details
Eligibility Criteria
Age Range6 Months — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:BrazilCameroonMadagascarMaliSenegalFrance
Unlock Eligibility Criteria
Competitive Landscape -Malaria 8 trials
CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Unlock Competitive Intelligence