Overview
Atovaquone is a hydroxynaphthoquinone, or an analog of ubiquinone, that has antimicrobial and antipneumocystis activity. It is being used in antimalarial protocols.
Indication
主要用于治疗恶性疟原虫感染（对氯喹敏感或耐药者）；还可用于艾滋病患者合并卡氏肺囊虫病或弓形原虫性脑炎等治疗以及轻中度不能耐受复方磺胺药的肺孢子菌肺炎（PCP肺炎）。
Associated Conditions
- Malaria caused by Plasmodium falciparum
- Pneumocystis Jirovecii Pneumonia
- Toxoplasma gondii encephalitis
- Acute, uncomplicated Malaria caused by plasmodium falciparum
- Mild Babesiosis
- Mild Pneumocystis jiroveci pneumonia
- Moderate Babesiosis
- Moderate Pneumocystis jiroveci pneumonia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/03 | Phase 1 | Recruiting | |||
2023/08/18 | Phase 2 | Recruiting | |||
2020/12/01 | Phase 1 | Completed | |||
2020/09/29 | Phase 1 | Completed | |||
2019/01/23 | Not Applicable | Terminated | |||
2018/10/31 | Phase 4 | UNKNOWN | Armed Forces Research Institute of Medical Sciences, Thailand | ||
2018/06/26 | Early Phase 1 | Active, not recruiting | |||
2018/03/05 | Not Applicable | Completed | |||
2015/12/11 | Early Phase 1 | Completed | |||
2015/09/30 | Phase 4 | Completed | State University of New York - Upstate Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chartwell RX, LLC | 62135-528 | ORAL | 750 mg in 5 mL | 7/21/2023 | |
| A-S Medication Solutions | 50090-2980 | ORAL | 250 mg in 1 1 | 2/2/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-3488 | ORAL | 250 mg in 1 1 | 8/24/2023 | |
| Abon Pharmaceuticals, LLC | 42239-001 | ORAL | 750 mg in 5 mL | 11/14/2023 | |
| Rebel Distributors Corp | 42254-150 | ORAL | 250 mg in 1 1 | 3/7/2012 | |
| Glenmark Pharmaceuticals Inc.,USA | 68462-402 | ORAL | 62.5 mg in 1 1 | 12/31/2019 | |
| Major Pharmaceuticals | 0904-7459 | ORAL | 750 mg in 5 mL | 8/13/2025 | |
| Golden State Medical Supply, Inc. | 51407-642 | ORAL | 750 mg in 5 mL | 2/8/2024 | |
| Physicians Total Care, Inc. | 54868-6393 | ORAL | 250 mg in 1 1 | 2/12/2013 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0631 | ORAL | 750 mg in 5 mL | 5/12/2025 |
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 | SIN09761P | TABLET, FILM COATED | 250 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 | N/A | N/A | 5/17/1999 |
TGA Drug Approvals
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 | 250 MG | 10/30/2017 |
| MALARONE | 02238151 | Tablet - Oral | 250 MG | 8/7/1998 | |
| MALARONE PEDIATRIC | 02264935 | Tablet - Oral | 62.5 MG | 5/17/2005 | |
| APO-ATOVAQUONE | 02471949 | Suspension - Oral | 750 MG / 5 ML | N/A | |
| MEPRON TAB 250MG | glaxo wellcome inc. | 02009358 | Tablet - Oral | 250 MG / TAB | 12/31/1993 |
| ATOVAQUONE PROGUANIL | sanis health inc | 02421429 | Tablet - Oral | 250 MG | 5/22/2014 |
| GLN-ATOVAQUONE | glenmark pharmaceuticals canada inc. | 02528495 | Suspension - Oral | 750 MG / 5 ML | 6/30/2022 |
| TEVA-ATOVAQUONE PROGUANIL | teva canada limited | 02380927 | Tablet - Oral | 250 MG | 3/1/2012 |
| MYLAN-ATOVAQUONE/PROGUANIL | Mylan Pharmaceuticals ULC | 02402165 | Tablet - Oral | 250 MG | 10/16/2013 |
| MEPRON | 02217422 | Suspension - Oral | 750 MG / 5 ML | 9/10/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| WELLVONE 750mg/5ml SUSPENSION ORAL | 63390 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MALAWAY 250 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 78402 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ATOVACUONA/HIDROCLORURO DE PROGUANIL SANDOZ 250 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 77842 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ATOVACUONA/HIDROCLORURO DE PROGUANIL VIATRIS 250 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 77267 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MALARONE 250 mg/100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 63452 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MALARONE PEDIATRICO 62,5 mg/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 65257 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ATOVACUONA GLENMARK 750 MG/5 ML SUSPENSION ORAL EFG | 84635 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
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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