Malaria continues to exact a heavy toll with 250 million reported cases in 2022. Some 95% of cases were from sub-Saharan Africa where Plasmodium falciparum malaria affects mostly young children under 5 years of age and pregnant women.
Approximately 600,000 people died in 2022 and more than 60% of all deaths were in children under 5. Plasmodium vivax, the other main species, is found more commonly outside of sub-Saharan Africa and is responsible for a small proportion of the global malaria burden.

Primaquine is an inexpensive antimalarial which plays two key roles in controlling malaria :

• blocking the transmission of Plasmodium falciparum
• killing the liver forms of Plasmodium vivax and Plasmodium ovale as part of ‘radical cure’

Primaquine tablets (15 mg) were first registered after the Second World War and in the mid 2000s, a 7.5 mg tablet was registered in the European Union; this was followed by another 15 mg tablet receiving WHO prequalification in December 2023. Thus, only three forms of primaquine are produced to international quality standards.

There are two international quality-assured primaquine dosage tablets – 15mg and 7,5 mg. The first primaquine tablets (15mg) received regulatory approval shortly after the Second World War. The second primaquine tablet (7,5mg) received regulatory approval in the European Union in the early 2000s.

In the active fight against malaria, there is an urgent need to optimise the galenic forms of primaquine in order to optimise treatments and to be able to deploy a large-scale strategy to treat all patients, wherever they are and whatever their age.

There is an urgent need to expand the current limited range of primaquine tablets and also produce child-friendly primaquine forms and strengths to ensure their acceptability and improve adherence to treatment, which is currently 7 or 14 days for radical cure, depending on the country where P. vivax was contracted.