Overview
Chloroquine is an aminoquinolone derivative first developed in the 1940s for the treatment of malaria. It was the drug of choice to treat malaria until the development of newer antimalarials such as pyrimethamine, artemisinin, and mefloquine. Chloroquine and its derivative hydroxychloroquine have since been repurposed for the treatment of a number of other conditions including HIV, systemic lupus erythematosus, and rheumatoid arthritis. The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020. Chloroquine was granted FDA Approval on 31 October 1949.
Background
Chloroquine is an aminoquinolone derivative first developed in the 1940s for the treatment of malaria. It was the drug of choice to treat malaria until the development of newer antimalarials such as pyrimethamine, artemisinin, and mefloquine. Chloroquine and its derivative hydroxychloroquine have since been repurposed for the treatment of a number of other conditions including HIV, systemic lupus erythematosus, and rheumatoid arthritis. The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020. Chloroquine was granted FDA Approval on 31 October 1949.
Indication
Chloroquine is indicated to treat infections of P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also used to treat extraintestinal amebiasis. Chloroquine is also used off label for the treatment of rheumatic diseases, as well as treatment and prophylaxis of Zika virus. Chloroquine is currently undergoing clinical trials for the treatment of COVID-19.
Associated Conditions
- Discoid Lupus Erythematosus (DLE)
- Extraintestinal Amebiasis
- Malaria
- Polymorphic Light Eruption (PLE)
- Porphyria Cutanea Tarda
- Rheumatoid Arthritis
- Sarcoidosis
- Acute, uncomplicated Malaria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Phase 3 | Recruiting | |||
2023/10/16 | Phase 4 | Recruiting | |||
2023/10/11 | Phase 1 | Recruiting | HonorHealth Research Institute | ||
2023/09/21 | Phase 4 | Completed | Dinka Dugassa | ||
2023/08/07 | Phase 4 | Completed | |||
2023/07/25 | N/A | Completed | Research Institute for Tropical Medicine, Philippines | ||
2023/03/28 | Phase 4 | Recruiting | |||
2022/02/17 | Phase 4 | Completed | |||
2021/01/12 | Phase 4 | Recruiting | |||
2020/11/13 | Phase 2 | Completed | Fundacion Clinica Valle del Lili |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvKARE | 42291-047 | ORAL | 500 mg in 1 1 | 11/15/2023 | |
| Suven Pharmaceuticals Limited | 68022-0265 | ORAL | 500 mg in 1 1 | 1/9/2024 | |
| Bayshore Pharmaceuticals LLC | 76385-142 | ORAL | 250 mg in 1 1 | 12/22/2023 | |
| Avet Pharmaceuticals Inc. | 23155-850 | ORAL | 500 mg in 1 1 | 5/25/2023 | |
| A-S Medication Solutions | 50090-4967 | ORAL | 250 mg in 1 1 | 10/9/2018 | |
| Suven Pharmaceuticals Limited | 68022-0264 | ORAL | 500 mg in 1 1 | 1/9/2024 | |
| Chartwell RX, LLC | 62135-717 | ORAL | 500 mg in 1 1 | 7/14/2023 | |
| Rising Pharmaceuticals, Inc. | 64980-177 | ORAL | 250 mg in 1 1 | 10/9/2018 | |
| Amneal Pharmaceuticals of New York LLC | 0115-7010 | ORAL | 500 mg in 1 1 | 12/30/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-2790 | ORAL | 250 mg in 1 1 | 8/3/2023 |
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 |
|---|---|---|---|---|---|
| CHLOROQUINE TABLETS 250 mg | SIN01559P | TABLET, FILM COATED | 250 mg | 5/26/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Chloroquine Phosphate Tablets | 国药准字H31020423 | 化学药品 | 片剂 | 3/13/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H51020072 | 化学药品 | 片剂 | 3/27/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H42022831 | 化学药品 | 片剂 | 9/17/2021 | |
| Chloroquine Phosphate Tablets | 国药准字H44021798 | 化学药品 | 片剂 | 1/5/2021 | |
| Chloroquine Phosphate Tablets | 国药准字H13023032 | 化学药品 | 片剂 | 8/25/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H12021143 | 化学药品 | 片剂 | 1/28/2022 | |
| Chloroquine Phosphate Tablets | 国药准字H31020698 | 化学药品 | 片剂 | 5/26/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H32020803 | 化学药品 | 片剂 | 8/21/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H51021869 | 化学药品 | 片剂 | 3/27/2020 | |
| Chloroquine Phosphate Tablets | 国药准字H44020115 | 化学药品 | 片剂 | 4/3/2020 |
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 |
|---|---|---|---|---|---|
| Chlorquin 250 mg Tablets bottle | 27904 | Medicine | A | 10/21/1991 |