Overview
A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents. [PubChem]
Indication
Used for the management of patients with chronic stable angina and for the treatment of hypertension.
Associated Conditions
- Chronic Stable Angina Pectoris
- Hypertension
- Migraine
- Blood pressure >185/110 mm Hg arterial hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/26 | Not Applicable | Recruiting | The Affiliated Hospital Of Guizhou Medical University | ||
2023/10/23 | Phase 4 | Recruiting | |||
2023/06/27 | Not Applicable | ENROLLING_BY_INVITATION | |||
2022/11/23 | Early Phase 1 | Completed | |||
2022/10/19 | Not Applicable | Completed | |||
2020/09/04 | Phase 3 | Completed | Pr. Semir Nouira | ||
2020/02/13 | Phase 2 | Completed | |||
2019/10/04 | Phase 2 | Completed | |||
2018/04/13 | Not Applicable | Completed | Chinese PLA General Hospital | ||
2017/06/12 | Early Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Civica, Inc. | 72572-470 | INTRAVENOUS | 2.5 mg in 1 mL | 5/1/2020 | |
| AuroMedics Pharma LLC | 55150-183 | INTRAVENOUS | 25 mg in 10 mL | 12/7/2021 | |
| Sandoz Inc. | 0781-9324 | INTRAVENOUS | 2.5 mg in 1 mL | 5/17/2011 | |
| SQUARE PHARMACEUTICALS LIMITED | 76483-087 | ORAL | 20 mg in 1 1 | 7/3/2023 | |
| Epic Pharma, LLC | 42806-501 | ORAL | 20 mg in 1 1 | 12/27/2023 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1482 | INTRAVENOUS | 25 mg in 10 mL | 2/23/2020 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1428 | INTRAVENOUS | 0.1 mg in 1 mL | 3/20/2020 | |
| Sandoz Inc. | 0781-3204 | INTRAVENOUS | 2.5 mg in 1 mL | 6/14/2011 | |
| Micro Labs Limited | 42571-394 | INTRAVENOUS | 2.5 mg in 1 mL | 7/14/2023 | |
| ANI Pharmaceuticals, Inc. | 62559-205 | ORAL | 20 mg in 1 1 | 7/22/2021 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CARDENE 20MG CAPSULES | Hoffmann-La Roche Limited | 02162741 | Capsule - Oral | 20 MG / CAP | 12/31/1996 |
| CARDENE 30MG CAPSULES | Hoffmann-La Roche Limited | 02162733 | Capsule - Oral | 30 MG / CAP | 1/21/1998 |
| CARDENE CAP 30MG | syntex inc. | 00791709 | Capsule - Oral | 30 MG | 12/31/1990 |
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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