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ferroquine

Phase 1

Malaria | Small molecule | Infectious Disease |Sanofi|Last Updated: Dec 21, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00563914A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated MalariaPHASE1 COMPLETED 72Oct 1, 2007Nov 1, 2008Dec 21, 20092 Gabon, Kenya
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Study Endpoints
Primary Endpoints
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
Secondary Endpoints
Parasite clearance assessed by repeated measurements of parasitemia
Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
up to 28 days after last dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ferroquine (SSR97193)DRUGassociated with artesunate
amodiaquineDRUGassociated with artesunate
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Body weight between 50 kg and 90 kg with Body Mass Index \>18 kg/m² * Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours * Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL Exclusion Criteria: * Hypersen...

Countries:GabonKenya
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Competitive Landscape -Malaria 8 trials