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ferroquine

Phase 1

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

ferroquine target and mechanism

ModalitySmall molecule

Also known as ferroquine (SSR97193)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

ferroquine clinical trials

ferroquine · 1 trial · 1 indication

Phase 1 1
NCT00563914A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated MalariaMalaria
COMPLETED72 Analytics
PHASE1COMPLETED
A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
MalariaUnlock trial analytics

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 to 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 19 trials

Frequently asked questions about ferroquine

What is ferroquine used for?

Ferroquine is an investigational small molecule being developed for the treatment of malaria. It has been studied in adult patients with uncomplicated malaria, where it was given in combination with artesunate. Ferroquine is not yet an approved medicine and remains in clinical development.

Who is developing ferroquine?

Ferroquine is being developed by Sanofi, the French pharmaceutical company whose shares trade under the ticker SNY. Sanofi holds the compound, which is also referenced in the literature by its internal code SSR97193. Development has focused on malaria as the target indication within the infectious disease therapeutic area.

What phase is ferroquine in?

Ferroquine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because the program has not advanced beyond Phase 1, ferroquine is investigational and is not an approved treatment for malaria or any other indication.

What clinical trials has ferroquine been studied in?

Ferroquine has been evaluated in one completed clinical trial, NCT00563914. That Phase 1 study compared ferroquine combined with artesunate against amodiaquine combined with artesunate in African adult male patients with uncomplicated malaria. It was randomized, actively controlled, and enrolled 72 participants across Gabon and Kenya.

Is ferroquine the same as SSR97193?

Yes. Ferroquine is also known by the code SSR97193, and the two names refer to the same investigational antimalarial compound. Searches for either name, including the combined form ferroquine (SSR97193), point to the same Sanofi development program for malaria.

How was ferroquine tested in its malaria trial?

Ferroquine was tested in NCT00563914, a completed Phase 1 study in African adults with uncomplicated malaria. Participants were randomized to ferroquine plus artesunate or amodiaquine plus artesunate, an active control. The trial enrolled 72 patients, was not double blinded, and was conducted in Gabon and Kenya.