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01.12.2012 | Review | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

Review of pyronaridine anti-malarial properties and product characteristics

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Simon L Croft, Stephan Duparc, Sarah J Arbe-Barnes, J Carl Craft, Chang-Sik Shin, Lawrence Fleckenstein, Isabelle Borghini-Fuhrer, Han-Jong Rim
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-270) contains supplementary material, which is available to authorized users.

Competing interests

Dr CS Shin is former Head of Pyramax Development at Shin Poong Pharmaceuticals (retired). Other authors declare that they have no competing interests.

Authors’ contributions

SLC, SD, SAB, LF and CSS drafted the manuscript. All authors read and approved the final manuscript.

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.
Zusatzmaterial
Additional file 1: Comparative activity of pyronaridine against chloroquine-susceptible and -resistan t P. falciparum field isolates from SE Asia and Africa.(DOC 126 KB)
12936_2012_2444_MOESM1_ESM.doc
Additional file 2: Comparative IC 5 0 for drug-resistant and -sensitive strains of P. falciparum.(DOC 298 KB)
12936_2012_2444_MOESM2_ESM.doc
Additional file 3: Acute toxicity studies with pyronaridine: summary of main findings.(DOC 138 KB)
12936_2012_2444_MOESM3_ESM.doc
Additional file 4: Sub-acute toxicity studies with pyronaridine: summary of main findings.(DOC 94 KB)
12936_2012_2444_MOESM4_ESM.doc
Additional file 5: Efficacy of pyronaridine monotherapy in patients with P. falciparum malaria: studies conducted in China. (DOC 86 KB)
12936_2012_2444_MOESM5_ESM.doc
Additional file 6: Oral monotherapy with pyronaridine in the treatment of falciparum malaria: International studies.(DOC 98 KB)
12936_2012_2444_MOESM6_ESM.doc
Additional file 7: Efficacy of oral pyronaridine combination therapy in patients with P. falciparum malaria. (DOC 140 KB)
12936_2012_2444_MOESM7_ESM.doc
Additional file 8: Clinical studies conducted in China of pyronaridine alone and in combination with primaquine in patients with P. vivax malaria. (DOC 104 KB)
12936_2012_2444_MOESM8_ESM.doc
Additional file 9: Treatment-emergent adverse events with pyronaridine oral monotherapy in the treatment of falciparum malaria.(DOC 88 KB)
12936_2012_2444_MOESM9_ESM.doc
Additional file 10: Treatment-emergent adverse events with fixed-dose pyronaridine-artesunate in the treatment of falciparum malaria in children.(DOC 66 KB)
12936_2012_2444_MOESM10_ESM.doc
Authors’ original file for figure 1
12936_2012_2444_MOESM11_ESM.pdf
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