Pyronaridine artesunate — Competitive Intelligence Brief

Pyronaridine artesunate (Pyronaridine artesunate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimalarial combination. Area: Infectious Disease.

marketed Antimalarial combination Plasmodium falciparum DNA; heme detoxification pathway Infectious Disease Small molecule

Target snapshot

Pyronaridine artesunate (Pyronaridine artesunate) — Medicines for Malaria Venture. Pyronaridine artesunate is a fixed-dose combination antimalarial that kills malaria parasites through dual mechanisms: pyronaridine intercalates into parasite DNA while artesunate generates reactive oxygen species that damage parasite structures.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Pyronaridine artesunate TARGET	Pyronaridine artesunate	Medicines for Malaria Venture	marketed	Antimalarial combination	Plasmodium falciparum DNA; heme detoxification pathway
artesunate-amodiaquine (AS-AQ)	artesunate-amodiaquine (AS-AQ)	Yale University	marketed	Artemisinin derivative + aminoquinoline antimalarial combination	Plasmodium falciparum heme iron (Fe2+), parasite DNA, heme polymerase
chlorproguanil-dapsone plus artesunate	chlorproguanil-dapsone plus artesunate	Centers for Disease Control and Prevention	marketed	Antimalarial combination	Dihydrofolate reductase (chlorproguanil/dapsone); mitochondrial function (artesunate)
Mefloquine- Artesunate	Mefloquine- Artesunate	Centers for Disease Control and Prevention	marketed	Antimalarial combination	Parasite heme detoxification pathway; artemisinin-iron adducts generating reactive oxygen species
amodiaquine plus sulfadoxine-pyrimethamine	amodiaquine plus sulfadoxine-pyrimethamine	Centers for Disease Control and Prevention	marketed	Antimalarial combination	Plasmodium DNA synthesis and folate metabolism pathway
Amodiaquine-artesunate (ASAQ)	Amodiaquine-artesunate (ASAQ)	Centers for Disease Control and Prevention	marketed	Antimalarial combination therapy	Plasmodium falciparum heme polymerase; artemisinin-derived endoperoxide bridge
IPTp-DP	IPTp-DP	Kenya Medical Research Institute	marketed	Antimalarial combination therapy	Plasmodium falciparum (malaria parasite)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antimalarial combination class)

1. Centers for Disease Control and Prevention · 4 drugs in this class
2. Armed Forces Research Institute of Medical Sciences, Thailand · 4 drugs in this class
3. London School of Hygiene and Tropical Medicine · 3 drugs in this class
4. Sanofi · 2 drugs in this class
5. Menzies School of Health Research · 2 drugs in this class
6. Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · 1 drug in this class
7. Epicentre · 1 drug in this class
8. Jhpiego · 1 drug in this class
9. Charite University, Berlin, Germany · 1 drug in this class
10. Ifakara Health Institute · 1 drug in this class