Overview
An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)
Indication
For the treatment of malaria.
Associated Conditions
- Malaria
- Malaria caused by Plasmodium ovale
- Malaria caused by plasmodium vivax
- Pneumocystis Jirovecii Pneumonia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Phase 3 | Recruiting | |||
2024/03/06 | Phase 1 | Completed | |||
2024/01/05 | Phase 4 | Completed | |||
2023/11/28 | Phase 3 | Recruiting | |||
2023/09/21 | Phase 4 | Completed | Dinka Dugassa | ||
2023/09/13 | Phase 2 | Completed | Syamsudin Abdillah,Ph.D, Pharm D | ||
2023/07/25 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/07/25 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/07/24 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/04/25 | Phase 2 | Completed | Syamsudin Abdillah,Ph.D, Pharm D |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvKARE | 42291-510 | ORAL | 15 mg in 1 1 | 1/9/2024 | |
| Bayshore Pharmaceuticals, LLC | 76385-102 | ORAL | 15 mg in 1 1 | 1/17/2020 | |
| Ingenus Pharmaceuticals, LLC | 50742-191 | ORAL | 15 mg in 1 1 | 1/31/2018 | |
| Aidarex Pharmaceuticals LLC | 33261-671 | ORAL | 15 mg in 1 1 | 9/8/2017 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-721 | ORAL | 15 mg in 1 1 | 5/19/2023 | |
| Sanofi-Aventis U.S. LLC | 0024-1596 | ORAL | 15 mg in 1 1 | 8/21/2019 |
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 |
|---|---|---|---|---|---|
| Primaquine Phosphate Tablets | 国药准字H51021839 | 化学药品 | 片剂(糖衣) | 12/18/2020 | |
| Primaquine Phosphate Tablets | 国药准字H31020472 | 化学药品 | 片剂(糖衣) | 9/18/2020 | |
| Primaquine Phosphate Tablets | 国药准字H20059843 | 化学药品 | 片剂(糖衣) | 3/13/2020 | |
| Primaquine Phosphate Tablets | 国药准字H50020205 | 化学药品 | 片剂 | 8/17/2020 | |
| Primaquine Phosphate Tablets | 国药准字H37020309 | 化学药品 | 片剂 | 3/1/2020 | |
| Primaquine Phosphate Tablets | 国药准字H50020542 | 化学药品 | 片剂 | 9/23/2020 |
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 |
|---|---|---|---|---|---|
| PRIMACIN primaquine (as phosphate) 7.5mg tablet bottle | 226430 | Medicine | A | 11/10/2014 |
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