{"id":"artefenomel","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT02497612","NCT01383096","NCT02573857","NCT04264130","NCT01732588","NCT01615822","NCT04069221","NCT03660839","NCT01213966","NCT02387580","NCT00928083","NCT02083380","NCT03542149","NCT01958619"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2009","type":"neutral","milestone":"Phase 1 Initiated","description":"A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Fe — Malaria Falciparum"},{"date":"2012","type":"neutral","milestone":"Phase 2 Initiated","description":"Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malari — Malaria, Falciparum"},{"date":"2015","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria — Uncomplicated Plasmodium Falciparum Malaria"}],"aiSummary":"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.","brandName":"ARTEFENOMEL","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"","explanation":"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.","oneSentence":"Artefenomel is an experimental malaria drug tested in adults as a single dose, sometimes combined with other malaria medicines.","technicalDetail":"The provided source text does not contain specific scientific details on molecular targets, pathways, or selectivity. It references an 'FDA mechanism text' section but the content of that section is not included in the provided data."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ARTEFENOMEL","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02497612","phase":"Phase 2","title":"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","status":"TERMINATED","sponsor":"Sanofi","isPivotal":false,"enrollment":377,"indication":"Plasmodium Falciparum Infection","completionDate":"2019-09-23"},{"nctId":"NCT01383096","phase":"Phase 1","title":"A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":52,"indication":"Healthy Volunteers","completionDate":"2012-08"},{"nctId":"NCT02573857","phase":"Phase 1","title":"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","status":"TERMINATED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":16,"indication":"Malaria","completionDate":"2016-05"},{"nctId":"NCT04264130","phase":"Phase 2","title":"Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection","status":"COMPLETED","sponsor":"Centre de Recherche Médicale de Lambaréné","isPivotal":false,"enrollment":54,"indication":"Schistosomiasis Haematobia","completionDate":"2019-12-31"},{"nctId":"NCT01732588","phase":"Phase 1","title":"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","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":11,"indication":"Healthy Volunteers","completionDate":"2012-12"},{"nctId":"NCT01615822","phase":"Phase 1","title":"A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine","status":"TERMINATED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":25,"indication":"Malaria","completionDate":"2013-04"},{"nctId":"NCT04069221","phase":"Phase 1","title":"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","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":26,"indication":"Malaria","completionDate":"2017-05-30"},{"nctId":"NCT03660839","phase":"Phase 2","title":"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","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":140,"indication":"Plasmodium Falciparum Infection","completionDate":"2019-11-06"},{"nctId":"NCT01213966","phase":"Phase 2","title":"Phase IIa Exploratory, Open Label, Single/Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and PK of OZ439 in Adult Patients With Acute, Uncomplicated P. Falciparu","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":82,"indication":"Malaria, Falciparum, Malaria, Vivax","completionDate":"2012-05"},{"nctId":"NCT02387580","phase":"Phase 1","title":"A Phase I Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 When Co-Administered With Piperaquine Phosphate ","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":48,"indication":"Malaria","completionDate":"2015-06"},{"nctId":"NCT00928083","phase":"Phase 1","title":"A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":63,"indication":"Malaria Falciparum, Malaria Vivax","completionDate":"2009-12"},{"nctId":"NCT02083380","phase":"Phase 2","title":"Randomised Phase IIb Study of Efficacy, Safety, Tolerability & Pharmacokinetics of a Single Dose Regimen of Artefenomel (OZ439) in Loose Combination With Piperaquine in Adults and Children With Uncomp","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":true,"enrollment":448,"indication":"Uncomplicated Plasmodium Falciparum Malaria","completionDate":"2015-11"},{"nctId":"NCT03542149","phase":"Phase 1","title":"Phase 1b to Assess Safety, Tolerability, Pharmacokinetic Profile, and Antimalarial Activity of Single Doses of Co-administered OZ439and PQP Against Early Plasmodium Falciparum Blood Stage Infection in","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":24,"indication":"Malaria","completionDate":"2019-04-19"},{"nctId":"NCT01958619","phase":"Phase 1","title":"Open Label Pharmacokinetic Study of OZ439 and Piperaquine Following Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral So","status":"COMPLETED","sponsor":"Medicines for Malaria Venture","isPivotal":false,"enrollment":55,"indication":"Malaria","completionDate":"2014-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}