Overview
Clevidipine is a dihydropyridine L-type calcium channel blocker that is selective for vascular smooth muscle and is indicated for blood pressure reduction when oral therapy is not an option.
Background
Clevidipine is a dihydropyridine L-type calcium channel blocker that is selective for vascular smooth muscle and is indicated for blood pressure reduction when oral therapy is not an option.
Indication
For the reduction of blood pressure when when oral antihypertensive therapy is not feasible or not desirable.
Associated Conditions
- Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/07 | N/A | Not yet recruiting | Zeenat Qureshi Stroke Institute | ||
2023/10/03 | Phase 4 | Not yet recruiting | |||
2023/06/28 | Phase 3 | Not yet recruiting | |||
2023/03/24 | Phase 3 | Not yet recruiting | |||
2022/01/03 | Phase 3 | Completed | ProMedica Health System | ||
2021/12/23 | N/A | Completed | Hospital de Cruces | ||
2020/12/17 | Phase 3 | UNKNOWN | Nanjing Yoko Biomedical Co., Ltd. | ||
2018/10/25 | Early Phase 1 | Completed | |||
2017/10/03 | Phase 4 | Withdrawn | |||
2013/12/13 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chiesi USA, Inc. | 10122-611 | INTRAVENOUS | 0.5 mg in 1 mL | 9/6/2022 | |
| Fresenius Kabi Austria GmbH | 18124-011 | INTRAVENOUS | 0.5 mg in 1 mL | 12/28/2018 | |
| Chiesi USA, Inc. | 10122-610 | INTRAVENOUS | 0.5 mg in 1 mL | 9/6/2022 |
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 |
|---|---|---|---|---|---|
| Clevidipine Injectable Emulsion | 国药准字H20249773 | 化学药品 | 注射剂 | 12/25/2024 | |
| Clevidipine Injectable Emulsion | 国药准字H20249774 | 化学药品 | 注射剂 | 12/25/2024 | |
| Clevidipine Injectable Emulsion | 国药准字H20244045 | 化学药品 | 注射剂 | 6/18/2024 |
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 |
|---|---|---|---|---|---|
| CLEVIPREX clevidipine, 50 mg in 100 mL injectable emulsion, Single Use Vials | 203314 | Medicine | A | 6/27/2013 | |
| CLEVIPREX clevidipine, 25 mg in 50 mL injectable emulsion, Single Use Vials | 203313 | Medicine | A | 6/27/2013 |