Evaluating the safety, pharmacokinetics, and antiparasitic activity of DSM265, a novel antimalarial plasmodium dihydroorotate dehydrogenase inhibitor: a systematic review and meta-analysis of early clinical trials

In this meta-analysis, DSM265 demonstrated a favorable safety profile after a single 400 mg dose. While preclinical signals of teratogenicity and testicular toxicity have halted further development, these effects were not reported in the included clinical trials. Substantial variability in PK parameters was noted, driven primarily by administered doses.