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 The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020.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.
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ARALEN | sanofi-synthelabo canada inc | 02017539 | Tablet - Oral | 250 MG | 12/31/1951 |
| TEVA-CHLOROQUINE | teva canada limited | 00021261 | Tablet - Oral | 250 MG | 12/31/1968 |
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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