Artemether

Overview

Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine for improved efficacy. This combination therapy exerts its effects against the erythrocytic stages of Plasmodium spp. and may be used to treat infections caused by P. falciparum and unidentified Plasmodium species, including infections acquired in chloroquine-resistant areas.

Indication

Artemether and lumefantrine combination therapy is indicated for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum, including malaria acquired in chloroquine-resistant areas. May also be used to treat uncomplicated malaria when the Plasmodium species has not been identified. Indicated for use in adults and children greater than 5 kg.

Associated Conditions

Malaria
Acute, uncomplicated Malaria caused by plasmodium falciparum

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine	2022/01/14	NCT05192265	Phase 2	Completed	University of Ibadan
Malaria Therapeutic Efficacy Study (TES) Kenya	2021/02/23	NCT04767191	Phase 4	Completed	Jhpiego
Southeast Asia Dose Optimization of Tafenoquine	2021/01/12	NCT04704999	Phase 4	Recruiting	University of Oxford
Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy	2020/12/10	NCT04661579	Phase 2	Completed	PATH
Controlled Human Malaria Infection Transmission Model - Phase A	2020/02/21	NCT04280692	Phase 1	Suspended	University of Oxford
Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali	2018/04/27	NCT03510481	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot	2016/04/19	NCT02742285	Phase 4	Completed	Thierry Buclin
An Extension Study of LON002 in Patients With Cancer	2015/03/18	NCT02390986	Not Applicable	UNKNOWN	LondonPharma Ltd.
A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours	2014/10/15	NCT02263950	Phase 1	UNKNOWN	LondonPharma Ltd.
Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects	2014/08/22	NCT02223871	Phase 1	Completed	Idorsia Pharmaceuticals Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COARTEM	Novartis Pharmaceuticals Corporation	0078-0568	ORAL	20 mg in 1 1	9/15/2017
COARTEM	Central Texas Community Health Centers	76413-154	ORAL	20 mg in 1 1	3/31/2015

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Artemether Injection	昆药集团股份有限公司	国药准字H10900012	化学药品	注射剂	8/12/2020
Artemether Injection	昆药集团股份有限公司	国药准字H10900011	化学药品	注射剂	8/12/2020
Artemether Capsules	昆药集团股份有限公司	国药准字H10920008	化学药品	胶囊剂	7/17/2020
Artemether Capsules	昆药集团股份有限公司	国药准字H10840006	化学药品	胶囊剂	7/6/2020
Artemether Capsules	昆药集团股份有限公司	国药准字H10920009	化学药品	胶囊剂	7/6/2020
Artemether Tablets	昆药集团股份有限公司	国药准字H10970018	化学药品	片剂	7/17/2020
Artemether Tablets	昆药集团股份有限公司	国药准字H20000014	化学药品	片剂	7/6/2020
Artemether Tablets	昆药集团股份有限公司	国药准字H10970019	化学药品	片剂	7/6/2020
Artemether Soft Capsules	重庆华友制药有限公司	国药准字H20063203	化学药品	胶囊剂(软胶囊)	7/31/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
RIAMET 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack	158523	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/9/2010
COARTEM artemether/lumefantrine 20 mg/120 mg tablet blister pack	298287	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	4/13/2018
COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack	158527	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/9/2010
RIAMET artemether/lumefantrine 20 mg/120 mg tablet blister pack	90011	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	7/24/2002

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