Overview
Levamlodipine, also known as S-amlodipine, is a pharmacologically active enantiomer of amlodipine, an antihypertensive medication. Levamlodipine belongs to the dihydropyridine group of calcium channel blockers. This medication was first marketed in Russia and India before being granted FDA approval. The names S-amlodipine and levamlodipine may be used interchangeably as both substances are the same, however. As a racemic mixture, amlodipine contains (R) and (S)-amlodipine isomers, but only (S)-amlodipine as the active moiety possesses therapeutic activity. Levamlodipine was granted FDA approval on 19 December 2019.
Background
Levamlodipine, also known as S-amlodipine, is a pharmacologically active enantiomer of amlodipine, an antihypertensive medication. Levamlodipine belongs to the dihydropyridine group of calcium channel blockers. This medication was first marketed in Russia and India before being granted FDA approval. The names S-amlodipine and levamlodipine may be used interchangeably as both substances are the same, however. As a racemic mixture, amlodipine contains (R) and (S)-amlodipine isomers, but only (S)-amlodipine as the active moiety possesses therapeutic activity. Levamlodipine was granted FDA approval on 19 December 2019.
Indication
Levamlodipine is indicated alone or in combination to treat hypertension in adults and children.
Associated Conditions
- Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/13 | Phase 3 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2023/07/17 | N/A | Recruiting | |||
2021/02/05 | Phase 2 | Completed | Affiliated Hospital of North Sichuan Medical College | ||
2020/09/18 | N/A | UNKNOWN | Ahn-Gook Pharmaceuticals Co.,Ltd | ||
2020/06/02 | Phase 1 | Completed | |||
2019/01/23 | Phase 3 | Withdrawn | EMS | ||
2018/09/05 | Phase 1 | Completed | |||
2017/07/21 | Phase 4 | UNKNOWN | |||
2015/02/09 | Phase 1 | Completed | |||
2014/09/26 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| CONJUPRI TABLETS 2.5MG | SIN17154P | TABLET | 2.50 mg | 12/26/2024 | |
| CONJUPRI TABLETS 5MG | SIN17153P | TABLET | 5.00 mg | 12/26/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Levamlodipine Maleate Dispersible Tablets | 国药准字H20110012 | 化学药品 | 片剂 | 10/23/2020 | |
| Levamlodipine Maleate Dispersible Tablets | 国药准字H20110011 | 化学药品 | 片剂 | 10/23/2020 | |
| Levoamlodipine Maleate Tablets | 国药准字H20030690 | 化学药品 | 片剂 | 3/27/2020 | |
| Levamlodipine Besylate Tablets | 国药准字H20249815 | 化学药品 | 片剂 | 12/25/2024 | |
| Levamlodipine Besylate Tablets | 国药准字H20243655 | 化学药品 | 片剂 | 4/30/2024 | |
| Levamlodipine Besylate Tablets | 常州瑞明药业股份有限公司 | 国药准字H20244599 | 化学药品 | 片剂 | 7/30/2024 |
| Levamlodipine Besylate Tablets | 国药准字H20244350 | 化学药品 | 片剂 | 6/28/2024 | |
| Levamlodipine Besylate Tablets | 国药准字H20143054 | 化学药品 | 片剂 | 12/5/2023 | |
| Levamlodipine Besylate Tablets | 国药准字H20234614 | 化学药品 | 片剂 | 12/5/2023 | |
| Levamlodipine Besylate Tablets | 国药准字H20243317 | 化学药品 | 片剂 | 3/5/2024 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||