Pyronaridine-artesunate granules

Pyronaridine-artesunate granules

Pyramax® granules
Shin Poong
Paediatric formulation
3-day cure, artemisinin-based combination therapies (TPP-1)
Therapeutic indication
  • For the treatment of uncomplicated malaria infection caused by P. falciparum or P. vivax in children and infants weighing 5 kg to under 20 kg

  • Once-daily for 3 days

  • 28-day PCR-corrected ACPR* >97%

  • 42-day PCR-corrected ACPR* 90%–95%

Key features
  • Only artemisinin-based combination therapy approved by a stringent regulatory authority for both P. falciparum and P. vivax (blood-stage)
  • No food restrictions
  • 2-year shelf life
  • Child-friendly granules
  • Country order fulfilment by major procurement bodies

  • Included in WHO Essential Medicines List for children & Included in WHO Guidelines for Malaria October 2022
  • Positive opinion from European Medicines Agency (Article 58). Cross-listed on WHO list of prequalified medicines
  • Approved in 21 countries & Included in 11 national treatment guidelines
  • Ongoing phase III study to assess safety and efficacy in mild to moderate Covid-19 patients (adult population)
Next milestone
  • Continued commercial introduction in malaria-endemic countries
  • Approval of 30-month shelf life
  • Development project team led by University of Iowa

Project Director
  • Adam Aspinall

* ACPR = adequate clinical and parasitological response