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.
Background
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 |
|---|---|---|---|---|---|
2024/03/06 | Phase 1 | Completed | |||
2021/04/30 | Phase 1 | Completed | Medicines for Malaria Venture | ||
2019/06/19 | Phase 4 | Withdrawn | Walter Reed Army Institute of Research (WRAIR) | ||
2017/06/07 | Phase 4 | Completed | |||
2015/05/21 | Phase 1 | Completed | Medicines for Malaria Venture | ||
2014/03/28 | Not Applicable | Completed | |||
2014/03/06 | Not Applicable | Completed | |||
2014/02/04 | Phase 1 | Completed | University Medical Center Goettingen | ||
2012/08/09 | Not Applicable | Completed | |||
2011/10/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-2980 | ORAL | 100 mg in 1 1 | 2/2/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-3488 | ORAL | 100 mg in 1 1 | 8/24/2023 | |
| Rebel Distributors Corp | 42254-150 | ORAL | 100 mg in 1 1 | 3/7/2012 | |
| Glenmark Pharmaceuticals Inc.,USA | 68462-402 | ORAL | 25 mg in 1 1 | 12/31/2019 | |
| Physicians Total Care, Inc. | 54868-6393 | ORAL | 100 mg in 1 1 | 2/12/2013 | |
| Glenmark Pharmaceuticals Inc.,USA | 68462-404 | ORAL | 100 mg in 1 1 | 12/31/2019 | |
| Proficient Rx LP | 63187-879 | ORAL | 100 mg in 1 1 | 10/1/2022 | |
| Mylan Pharmaceuticals Inc. | 0378-4162 | ORAL | 100 mg in 1 1 | 3/21/2019 | |
| Prasco Laboratories | 66993-060 | ORAL | 100 mg in 1 1 | 2/2/2021 | |
| 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 | 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 | glaxosmithkline limited | N/A | N/A | 5/17/1999 |