title: Review of pyronaridine anti-malarial properties and product characteristics.
abstract: Pyronaridine was synthesized in 1970 at the Institute of Chinese Parasitic Disease and has been used in China for over 30 years for the treatment of malaria. Pyronaridine has high potency against Plasmodium falciparum, including chloroquine-resistant strains. Studies in various animal models have shown pyronaridine to be effective against strains resistant to other anti-malarials, including chloroquine. Resistance to pyronaridine appears to emerge slowly and is further retarded when pyronaridine is used in combination with other anti-malarials, in particular, artesunate. Pyronaridine toxicity is generally less than that of chloroquine, though evidence of embryotoxicity in rodents suggests use with caution in pregnancy. Clinical pharmacokinetic data for pyronaridine indicates an elimination T1/2 of 13.2 and 9.6 days, respectively, in adults and children with acute uncomplicated falciparum and vivax malaria in artemisinin-combination therapy. Clinical data for mono or combined pyronaridine therapy show excellent anti-malarial effects against P. falciparum and studies of combination therapy also show promise against Plasmodium vivax. Pyronaridine has been developed as a fixed dose combination therapy, in a 3:1 ratio, with artesunate for the treatment of acute uncomplicated P. falciparum malaria and blood stage P. vivax malaria with the name of Pyramax® and has received Positive Opinion by European Medicines Agency under the Article 58 procedure.
authors.affiliation: Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. simon.croft@lshtm.ac.uk
authors.forename: Simon L
authors.initials: SL
authors.lastname: Croft
authors.forename: Stephan
authors.initials: S
authors.lastname: Duparc
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Arbe-Barnes
authors.forename: J Carl
authors.initials: JC
authors.lastname: Craft
authors.forename: Chang-Sik
authors.initials: CS
authors.lastname: Shin
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fleckenstein
authors.forename: Isabelle
authors.initials: I
authors.lastname: Borghini-Fuhrer
authors.forename: Han-Jong
authors.initials: HJ
authors.lastname: Rim
mesh_terms: D000962:Antimalarials / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D002681:China; D004359:Drug Therapy, Combination / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D016780:Malaria, Vivax / Q000188:drug therapy*; D009287:Naphthyridines / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D010963:Plasmodium falciparum / Q000187:drug effects; D010966:Plasmodium vivax / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D009287:Naphthyridines; C027871:pyronaridine