Four single-arm, prospective, clinical studies of pyronaridine-artesunate efficacy in uncomplicatedormalaria were conducted in Myanmar between 2017 and 2019. Eligible subjects were aged at least 6 years, with microscopically confirmed(= 196) ormono-infection (= 206). Patients received pyronaridine-artesunate once daily for 3 days with follow-up until day 42 foror day 28 for. For the primary efficacy analysis, adequate clinical and parasitological response (ACPR) in the per-protocol population at day 42 formalaria was 100% (88/88; 95% CI: 95.9, 100) in northern Myanmar (Kachin State and northern Shan State), and 100% (101/101; 95% CI: 96.4, 100) in southern Myanmar (Tanintharyi Region and Kayin State).day-3 parasite clearance was observed for 96.9% (190/196) of patients. Mutations in theKelch propeller domain () were detected in 39.0% (69/177) of isolates: F446I (14.7% [26/177]), R561H (13.0% [23/177]), C580Y (10.2% [18/177]), and P574L (1.1% [2/177]). For, the day-28 ACPR was 100% (104/104; 95% CI: 96.5, 100) in northern Myanmar and 100% (97/97; 95% CI: 96.3, 100) in southern Myanmar. Across bothstudies, 100% (206/206) of patients had day-3 parasite clearance. There were no adverse events. Pyronaridine-artesunate had excellent efficacy in Myanmar againstandand was well tolerated. This study supports the inclusion of pyronaridine-artesunate in national malaria treatment guidelines for Myanmar. Plasmodium falciparum Plasmodium vivax P. falciparum n P. vivax n P. falciparum P. vivax P. falciparum Plasmodium falciparum P. falciparum K13P. vivax P. vivax P. falciparum P. vivax
