In a monumental step toward combating relapsing malaria, the World Health Organization (WHO) has granted prequalification to tafenoquine, the first-ever single-dose medicine aimed at preventing relapses of Plasmodium vivax (P. vivax) malaria. This breakthrough medication, co-administered with chloroquine, has also been included in WHO’s updated Guidelines for Malaria Treatment.
What Makes Tafenoquine a Game-Changer?
The inclusion of tafenoquine addresses the significant global health challenge posed by relapsing malaria, especially among children and vulnerable populations in tropical regions outside sub-Saharan Africa. With its single-dose regimen, the drug overcomes patient compliance issues often associated with the existing multi-day treatment protocols.
Key Features:

• Targeted Treatment: Tafenoquine works against the liver-stage of P. vivax, providing what is termed as a “radical cure,” by treating both blood and dormant liver stages of the parasite.

• Wider Accessibility: Approved for both adults and children over 2 years old and weighing at least 10 kg.

• Safety Protocols: Requires G6PD testing to prevent hemolytic anemia in susceptible individuals.

The Burden of P. vivax Malaria
Plasmodium vivax accounts for approximately 8.5 million cases annually, predominantly affecting South Asia, Southeast Asia, Latin America, and the Horn of Africa. Among the hardest hit are young children, migrant workers, and those in rural malaria-endemic areas, who face recurring episodes of fever, anemia, and severe disease.
Collaborative Efforts in Development
Tafenoquine’s development represents over 20 years of research, spearheaded by a partnership between GSK and the non-profit Medicines for Malaria Venture (MMV). The drug has already been approved in countries like Brazil, Thailand, and Australia, with marketing authorization underway in other endemic nations.
Thomas Breuer, Chief Global Health Officer at GSK, called the milestone “a significant leap toward malaria elimination.” Similarly, Martin Fitchet, CEO of MMV, emphasized its potential to transform treatment paradigms and save lives in the world’s most vulnerable communities.
Why This Matters
The single-dose tafenoquine offers:

• Enhanced treatment compliance

• Lower likelihood of recurrent malaria episodes

• Reduced public health burden of malaria, including the economic impact in low-income countries

Additionally, the introduction of the STANDARD G6PD Test, a rapid diagnostic developed by SD Biosensor and PATH, enables safe prescription of tafenoquine, ensuring wider adoption in resource-limited settings.
Looking Ahead
This approval aligns with global malaria elimination goals, bringing hope to millions who battle recurring malaria. As P. vivax continues to challenge health systems worldwide, innovations like tafenoquine signify the power of partnerships and advancements in tackling preventable diseases.