Develop and register a fixed-dose combination of artesunate (AS) and amodiaquine (AQ) to treat paediatric and adult uncomplicated falciparum malaria
current phase of drug development
updated 31 May 2019
Short-course fixed-dose combination for easier administration
Affordable, fixed-dose drug combination simplifies malaria treatment
With older antimalarial medicines increasingly ineffective due to growing drug resistance, in 2001 WHO recommended the use of artemisinin-based combination therapies as first-line malaria treatment.
However, there were no combinations of the recommended drugs. This meant that people had to take each drug in separate tablets – complicating administration and increasing the likelihood of drug resistance developing due to people not taking the full and correct dose of both medicines.
The dispersible, fixed-dose combination of artesunate and amodiaquine (ASAQ) requires only one dose per day for three days, reducing the “pill burden” for both adults and children. It is also easier to administer to infants and young children because it dissolves in water. A dual-aluminium blister packaging ensures a three-year shelf-life, even in a tropical environment.
ASAQ was developed as a public good, so it is affordable and has no patents, making it available for production by any generic drug manufacturer that meets quality standards.
- Indication: Malaria
- Dosage: Single daily fixed-dose combination of artesunate & amodiaquine for 3 days
- Registered in 35 countries and territories since 2007
- More than 540 million treatments distributed since 2007
- First registered in Morocco to enable rapid exportation to other African countries
- No patent: Developed as a public good, so any generic company meeting quality standards can produce it
- Technology transfer to Zenufa (Tanzania)
- Five different manufacturers’ ASAQ products are now prequalified by WHO
- Handed over to Medicines for Malaria Venture access team in 2015 for continued implementation
- Released at a cost of only US $0.50 for children, US $1.00 for adults
History – the FACT project
In response to WHO’s recommendation of artesunate combination therapies to treat malaria, Médecins Sans Frontières, the WHO Special Programme for Research and Training in Tropical Diseases, and other partners established the Fixed-Dose-Artesunate Combination Therapy (FACT) project in 2002. When DNDi was created in 2003, it took over management of the FACT project.
FACT’s objective was to develop two fixed-dose combination therapies containing artemisinin for the treatment of malaria. The urgency of these goals was confirmed by WHO’s 2006 malaria treatment guidelines calling for an immediate halt to artemisinin monotherapy, to prevent the creation of drug resistance. ASAQ was first released in 2007.
‘This new fixed-dose combination has been adapted to patients’ needs by being simple to use, more affordable, and a quality product. The fact that ASAQ was made so affordable right from the start and is not under patent removes a significant barrier to its availability and should serve as a model for future drug development for neglected diseases.’
Dr Bernard Pécoul, Founder, DNDi
News & resources
- 9 June 2015 - After more than a decade of effort and achievements, DNDi hands over malaria programme to MMV
- 31 March 2015 - The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: A meta-analysis of individual patient data, BMC Medicine
- 16 December 2014 - Fixed dose artesunate amodiaquine – A phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine, Malaria Journal
- 25 March 2014 - Plasmodium falciparum clearance in clinical studies of artesunate-amodiaquine and comparator treatments in sub-Saharan Africa, 1999–2009, Malaria Journal
- 22 July 2013 - Efficacy of artesunate-amodiaquine and artemether-lumefantrine fixed-dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria among children aged six to 59 months in Nimba County, Liberia: An open-label randomized non-inferiority trial, Malaria Journal
- 22 July 2013 - Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: Two open-label, randomized trials in Nimba County, Liberia, Malaria Journal
- 8 June 2009 - Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria, Malaria Journal
- 16 October 2008 - Coarsucam™ (artesunate/amodiaquine) first fixed-dose antimalarial combination to receive WHO Prequalification
- 1 March 2007 - New, Once-a-Day Fixed-Dose Combination Against Malaria Now Available
More about ASAQ:
*Project cost includes direct and indirect costs, but it does not include in-kind contributions.
Photo credit: FBBVA
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