Skip to main content

artemether; lumefantrine

Generic: ARTEMETHER; LUMEFANTRINE·Brand: COARTEM

artemether; lumefantrine: sourced relationships with 1 company · 2 clinical trials tracked · 1 FDA decision.

artemether; lumefantrine evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect artemether; lumefantrine to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could artemether; lumefantrine → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

Uncomplicated Plasmodium Falciparum Malaria; Severe MalariaUncomplicated Plasmodium Falciparum Malaria

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Novartis AG (NVS)
Reported 2009-04-07 · Current development: unknownSource
Uncomplicated Plasmodium Falciparum Malaria; Severe Malaria
Phase 4
Clinical Trial Registry Records (2)

An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium Falciparum Malaria (KARISMA - KAE609's Role In Severe Malaria)

NCT04675931Registry updated 2026-04-09·Phase 2
Completed

Primary endpoint: Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum) at 12 Hours

InterventionalRandomizedsingle254 enrolledStarted 2022-03Completion 2025-089 sites · Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Kenya…Novartis Pharmaceuticals

A Phase 2 Interventional, Multicenter, Randomized, Open-label Study in Three Age-descending Cohorts to Evaluate Efficacy, Safety and Tolerability of KAF156 and Lumefantrine-SDF Combination in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in a Pediatric Population

NCT04546633Registry updated 2026-05-07·Phase 2
Completed

Primary endpoint: Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) - Cohorts 1 and 2 Pooled

InterventionalRandomizedsingle295 enrolledStarted 2021-02Completion 2024-089 sites · Burkina Faso, Côte d’Ivoire, Gabon, Mali…Novartis Pharmaceuticals
FDA Decisions1 records
Approval(NVS)FDA ↗
NDA022268Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with artemether; lumefantrine?

artemether; lumefantrine has dated SEC/FDA relationship records for Novartis AG.

How many clinical trials involve artemether; lumefantrine?

BioSniper tracks 2 clinical trials involving artemether; lumefantrine.

What is artemether; lumefantrine's latest FDA decision?

The most recent tracked FDA decision for artemether; lumefantrine is Approval, dated April 7, 2009.