Last reviewed 2026-04-19 · How we verify

ARTEFENOMEL

Artefenomel is an experimental malaria drug tested in adults as a single dose, sometimes combined with other malaria medicines.

Artefenomel (OZ439) is an antimalarial drug that has been evaluated in Phase 1 and 2 clinical trials for the treatment of uncomplicated Plasmodium falciparum or vivax malaria. Its primary differentiator is investigation as a single-dose therapy, including combinations with mefloquine or piperaquine.

At a glance

Mechanism of action

The provided source text does not contain a plain English mechanism of action description. It only lists titles of clinical trial summaries and an 'FDA mechanism text' placeholder without the actual mechanism content.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Ch (Phase 2)
• A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers (Phase 1)
• A Phase Ib Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodiu (Phase 1)
• Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection (Phase 2)
• Three Way Randomised CrossOver Study in Healthy Subjects to Compare the Relative Bioavailability of Nanoparticulate OZ439 Delivered Via the Enterion™ Capsule to the Proximal Small Bowel With Orally Ad (Phase 1)
• A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine (Phase 1)
• An Open-label, Two-part Study to Determine the Absolute Bioavailability (BA) of OZ439 Using Simultaneous Intravenous [14C]-OZ439 Microdose/800mg Oral Dosing and to Investigate the Pharmacokinetics (PK (Phase 1)
• A Randomized, Open Label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) G (Phase 2)

Primary sources

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