Overview
An alkaloid derived from the bark of the cinchona tree. It is used as an antimalarial drug, and is the active ingredient in extracts of the cinchona that have been used for that purpose since before 1633. Quinine is also a mild antipyretic and analgesic and has been used in common cold preparations for that purpose. It was used commonly and as a bitter and flavoring agent, and is still useful for the treatment of babesiosis. Quinine is also useful in some muscular disorders, especially nocturnal leg cramps and myotonia congenita, because of its direct effects on muscle membrane and sodium channels. The mechanisms of its antimalarial effects are not well understood.
Background
An alkaloid derived from the bark of the cinchona tree. It is used as an antimalarial drug, and is the active ingredient in extracts of the cinchona that have been used for that purpose since before 1633. Quinine is also a mild antipyretic and analgesic and has been used in common cold preparations for that purpose. It was used commonly and as a bitter and flavoring agent, and is still useful for the treatment of babesiosis. Quinine is also useful in some muscular disorders, especially nocturnal leg cramps and myotonia congenita, because of its direct effects on muscle membrane and sodium channels. The mechanisms of its antimalarial effects are not well understood.
Indication
For the treatment of malaria and leg cramps
Associated Conditions
- Uncomplicated Malaria caused by Plasmodium falciparum
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/25 | Not Applicable | Completed | |||
2021/05/05 | Phase 1 | Recruiting | |||
2019/06/14 | Phase 4 | Completed | |||
2016/11/28 | Phase 3 | Completed | University of Bamenda | ||
2016/05/03 | Not Applicable | UNKNOWN | |||
2015/12/15 | Phase 1 | Terminated | |||
2015/09/30 | Phase 3 | Completed | University of Yaounde 1 | ||
2015/07/08 | Phase 2 | Completed | |||
2014/10/28 | Phase 2 | Withdrawn | |||
2014/03/20 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Donna Restivo DC | 62185-0059 | ORAL | 6 [hp_X] in 1 mL | 5/23/2025 | |
| Sun Pharmaceutical Industries, Inc. | 49708-153 | ORAL | 324 mg in 1 1 | 8/29/2019 | |
| STAT RX USA LLC | 16590-595 | ORAL | 324 mg in 1 1 | 3/18/2010 | |
| King Bio Inc. | 57955-2830 | ORAL | 10 [hp_X] in 59 mL | 5/20/2025 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3002 | ORAL | 324 mg in 1 1 | 1/31/2023 | |
| Amneal Pharmaceuticals LLC | 65162-811 | ORAL | 324 mg in 1 1 | 12/20/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-560 | ORAL | 324 mg in 1 1 | 10/31/2023 | |
| Deseret Biologicals, Inc. | 43742-2178 | ORAL | 6 [hp_X] in 1 mL | 4/22/2025 | |
| Ingenus Pharmaceuticals, LLC | 50742-238 | ORAL | 324 mg in 1 1 | 8/28/2019 | |
| King Bio Inc. | 57955-5276 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Quinine Sulfate Tablets | 国药准字H37021958 | 化学药品 | 片剂 | 3/25/2020 | |
| Quinine Sulfate Tablets | 国药准字H42021750 | 化学药品 | 片剂(糖衣) | 6/10/2020 | |
| Quinine Sulfate Tablets | 国药准字H44020369 | 化学药品 | 片剂 | 4/21/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53020844 | 化学药品 | 注射剂 | 8/27/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53020197 | 化学药品 | 注射剂 | 6/30/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53021286 | 化学药品 | 注射剂 | 9/28/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53021288 | 化学药品 | 注射剂 | 9/28/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53020629 | 化学药品 | 注射剂 | 11/24/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53020845 | 化学药品 | 注射剂 | 8/27/2020 | |
| Quinine Dihydrochloride Injection | 国药准字H53020922 | 化学药品 | 注射剂 | 8/12/2020 |
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 |
|---|---|---|---|---|---|
| QUININE DIHYDROCHLORIDE 6% sterile concentrate (600 mg/10 mL) injection vial | 23101 | Medicine | A | 10/14/1991 | |
| QUINSUL quinine sulfate dihydrate 300mg tablet bottle | 55556 | Medicine | A | 6/3/1996 | |
| QUINATE quinine sulfate dihydrate 300mg tablet jar (reformulation) | 50707 | Medicine | A | 11/22/1994 |