Proguanil

Overview

Proguanil is a prophylactic antimalarial drug, which works by stopping the malaria parasite, Plasmodium falciparum and Plasmodium vivax, from reproducing once it is in the red blood cells. It does this by inhibiting the enzyme, dihydrofolate reductase, which is involved in the reproduction of the parasite.

Indication

For the causal prevention and suppression of malaria caused by susceptible strains of P. falciparum and other species of Plasmodium found in some geographical areas of the world.

Associated Conditions

Malaria caused by Plasmodium falciparum
Acute, uncomplicated Malaria caused by plasmodium falciparum

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)	2024/03/06	NCT06294912	Phase 1	Completed	Merck Sharp & Dohme LLC
Atoguanil BA Study	2021/04/30	NCT04866602	Phase 1	Completed	Medicines for Malaria Venture
Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment	2019/06/19	NCT03991208	Phase 4	Withdrawn	Walter Reed Army Institute of Research (WRAIR)
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)	2017/06/07	NCT03178643	Phase 4	Completed	Duke University
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria	2015/05/21	NCT02450578	Phase 1	Completed	Medicines for Malaria Venture
Chemoprophylaxis and Plasmodium Falciparum NF54 Sporozoite Immunization Challenged by Heterologous Infection	2014/03/28	NCT02098590	Not Applicable	Completed	Radboud University Medical Center
Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis	2014/03/06	NCT02080026	Not Applicable	Completed	Radboud University Medical Center
Open Label Pharmacokinetic-Pharmacogenetic Study on Polymorphisms in the Organic Cation Transporter OCT1	2014/02/04	NCT02054299	Phase 1	Completed	University Medical Center Goettingen
Re-exposure of Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites	2012/08/09	NCT01660854	Not Applicable	Completed	Radboud University Medical Center
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel	2011/10/20	NCT01456546	Phase 1	Completed	University of Southern Denmark

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Atovaquone and Proguanil HCl	A-S Medication Solutions	50090-2980	ORAL	100 mg in 1 1	2/2/2021
Atovaquone and Proguanil Hydrochloride	NuCare Pharmaceuticals,Inc.	68071-3488	ORAL	100 mg in 1 1	8/24/2023
Atovaquone and Proguanil Hydrochloride	Rebel Distributors Corp	42254-150	ORAL	100 mg in 1 1	3/7/2012
Atovaquone and Proguanil Hydrochloride Pediatric	Glenmark Pharmaceuticals Inc.,USA	68462-402	ORAL	25 mg in 1 1	12/31/2019
Atovaquone and Proguanil Hydrochloride	Physicians Total Care, Inc.	54868-6393	ORAL	100 mg in 1 1	2/12/2013
Atovaquone and Proguanil Hydrochloride	Glenmark Pharmaceuticals Inc.,USA	68462-404	ORAL	100 mg in 1 1	12/31/2019
Atovaquone and Proguanil Hydrochloride	Proficient Rx LP	63187-879	ORAL	100 mg in 1 1	10/1/2022
Atovaquone and Proguanil Hydrochloride	Mylan Pharmaceuticals Inc.	0378-4162	ORAL	100 mg in 1 1	3/21/2019
Atovaquone and Proguanil HCl	Prasco Laboratories	66993-060	ORAL	100 mg in 1 1	2/2/2021
Atovaquone and Proguanil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	43063-393	ORAL	100 mg in 1 1	9/26/2023

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
MALARONE TABLET	Bora Pharmaceutical Services Inc., GLAXO WELLCOME S.A. (Primary and Secondary Packing)	SIN09761P	TABLET, FILM COATED	100 mg	5/16/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MALARONE TAB	N/A	葛兰素史克	N/A	N/A	5/17/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ATOVAQUOPRO GH 250/100 atovaquone/proguanil hydrochloride 250/100 mg film-coated tablet bottle	370790	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO LUPIN 250/100 atovaquone/proguanil hydrochloride 250/100 mg film-coated tablet blister pack	370798	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO GH 62.5/25 atovaquone/proguanil hydrochloride 62.5/25 mg film-coated tablet bottle	370792	Generic Health Pty Ltd	Medicine	A	8/16/2022
MALARONE TABLETS (250/100) atovaquone and proguanil hydrochloride tablet blister pack	61100	GlaxoSmithKline Australia Pty Ltd	Medicine	A	5/4/1998
ATOVAQUOPRO LUPIN 62.5/25 atovaquone/proguanil hydrochloride 62.5/25 mg film-coated tablet bottle	370797	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO LUPIN 250/100 atovaquone/proguanil hydrochloride 250/100 mg film-coated tablet bottle	370793	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO GH 62.5/25 atovaquone/proguanil hydrochloride 62.5/25 mg film-coated tablet blister pack	370795	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO LUPIN 62.5/25 atovaquone/proguanil hydrochloride 62.5/25 mg film-coated tablet blister pack	370794	Generic Health Pty Ltd	Medicine	A	8/16/2022
ATOVAQUOPRO GH 250/100 atovaquone/proguanil hydrochloride 250/100 mg film-coated tablet blister pack	370796	Generic Health Pty Ltd	Medicine	A	8/16/2022
MALARONE JUNIOR TABLETS (62.5/25) atovaquone and proguanil hydrochloride tablet blister pack	92855	GlaxoSmithKline Australia Pty Ltd	Medicine	A	3/26/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS	glenmark pharmaceuticals canada inc.	02466783	Tablet - Oral	100 MG	10/30/2017
MALARONE	GlaxoSmithKline Inc	02238151	Tablet - Oral	100 MG	8/7/1998
PALUDRINE TAB 0.1GM	ayerst laboratories	00316962	Tablet - Oral	100 MG / TAB	12/31/1974
MALARONE PEDIATRIC	GlaxoSmithKline Inc	02264935	Tablet - Oral	25.0 MG	5/17/2005
ATOVAQUONE PROGUANIL	sanis health inc	02421429	Tablet - Oral	100 MG	5/22/2014
TEVA-ATOVAQUONE PROGUANIL	teva canada limited	02380927	Tablet - Oral	100 MG	3/1/2012
MYLAN-ATOVAQUONE/PROGUANIL	Mylan Pharmaceuticals ULC	02402165	Tablet - Oral	100 MG	10/16/2013

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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