Overview
Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers . Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure . The option for single daily dosing of amlodipine is an attractive feature of this drug .
Indication
Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions : • Hypertension • Coronary artery disease • Chronic stable angina • Vasospastic angina (Prinzmetal’s or Variant angina) • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%
Associated Conditions
- Cardiovascular Events
- Chronic Stable Angina Pectoris
- Coronary Artery Disease (CAD)
- Homozygous Familial Hypercholesterolaemia (HoFH)
- Hypertension
- Hypertension, Essential Hypertension
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
- Vasospastic Angina
Research Report
Comprehensive Analysis of Amlodipine (DB00381): A Foundational Cardiovascular Therapeutic
Executive Summary
Amlodipine is a third-generation dihydropyridine calcium channel blocker (CCB) that stands as a cornerstone therapy in cardiovascular medicine. Its clinical utility is anchored in its unique pharmacokinetic profile, characterized by a slow onset of action and a long elimination half-life, which translates to sustained, 24-hour blood pressure control with once-daily dosing and a favorable tolerability profile compared to earlier CCBs. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension, chronic stable angina, and vasospastic angina. Furthermore, it holds a specific indication for reducing the risk of hospitalization for angina and the need for coronary revascularization procedures in patients with documented coronary artery disease (CAD). Its versatility is further demonstrated by its extensive use as a foundational component in numerous fixed-dose combination therapies, targeting multiple facets of cardiovascular risk. This report provides an exhaustive analysis of Amlodipine's chemical properties, pharmacological mechanisms, clinical evidence base, safety profile, and its comparative position within the broader class of antihypertensive agents.
Section 1: Molecular Profile and Pharmaceutical Formulations
1.1 Chemical Identity and Nomenclature
Amlodipine is a small molecule drug classified chemically as a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative.[1] Its identity is precisely defined by established chemical and regulatory identifiers.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/20 | Not Applicable | Not yet recruiting | |||
2025/04/24 | Phase 2 | Not yet recruiting | |||
2024/12/03 | Phase 4 | Withdrawn | |||
2024/07/26 | Phase 4 | Recruiting | |||
2024/06/18 | Phase 3 | Completed | |||
2024/05/22 | Phase 2 | Recruiting | |||
2024/05/02 | Phase 3 | Completed | Oslo University Hospital | ||
2024/02/14 | N/A | Completed | |||
2024/01/05 | Phase 1 | Not yet recruiting | International Bio service | ||
2023/11/29 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Par Pharmaceutical, Inc. | 49884-786 | ORAL | 5 mg in 1 1 | 10/10/2023 | |
ScieGen Pharmaceuticals, Inc | 50228-368 | ORAL | 10 mg in 1 1 | 12/10/2018 | |
Dr. Reddy's Laboratories Inc | 43598-318 | ORAL | 10 mg in 1 1 | 2/16/2021 | |
Alembic Pharmaceuticals Inc. | 62332-755 | ORAL | 2.5 mg in 1 1 | 5/23/2025 | |
Mylan Pharmaceuticals Inc. | 0378-4513 | ORAL | 5 mg in 1 1 | 1/26/2022 | |
Quality Care Products, LLC | 83008-039 | ORAL | 10 mg in 1 1 | 8/18/2023 | |
Northwind Pharmaceuticals, LLC | 51655-044 | ORAL | 5 mg in 1 1 | 1/1/2024 | |
Marlex Pharmaceuticals, Inc. | 10135-759 | ORAL | 2.5 mg in 1 1 | 10/15/2022 | |
Bryant Ranch Prepack | 71335-1278 | ORAL | 5 mg in 1 1 | 3/29/2023 | |
Dr. Reddy's Laboratories Inc | 43598-320 | ORAL | 2.5 mg in 1 1 | 2/16/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 3/22/2016 | ||
Authorised | 3/22/2016 | ||
Authorised | 10/15/2009 | ||
Authorised | 1/15/2007 | ||
Authorised | 3/22/2016 | ||
Authorised | 3/22/2016 | ||
Authorised | 11/3/2009 | ||
Authorised | 10/7/2010 | ||
Authorised | 11/3/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AMLOTENS TABLET 10MG | SIN13785P | TABLET | 10 mg | 4/9/2010 | |
NORVASC TABLET 5 mg | SIN05277P | TABLET | 5 mg | 12/27/1990 | |
AMCAD 5 TABLET 5 mg | SIN14529P | TABLET | 5 mg | 3/27/2014 | |
ACTAPIN TABLET 5MG | SIN13537P | TABLET | 5 mg | 8/25/2008 | |
ANLODIN TABLET 5MG | SIN14630P | TABLET | 5mg | 9/22/2014 | |
APO-AMLODIPINE TABLET 10mg | SIN14160P | TABLET | 10.0mg | 6/18/2012 | |
AMLOPIN TABLET 5MG | SIN15498P | TABLET | 5mg | 5/28/2018 | |
AMLOSIN 5 AMLODIPINE TABLET 5MG | SIN14908P | TABLET | 5 mg | 12/17/2015 | |
Zynor Tablet 5mg | SIN14213P | TABLET | 5mg | 8/22/2012 | |
CADUET TABLETS 5MG/20MG | SIN13056P | TABLET, FILM COATED | 5 MG | 3/10/2005 |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
NB-AMLODIPINE | nb pharma inc. | 02556715 | Tablet - Oral | 5 MG | N/A |
NB-AMLODIPINE | nb pharma inc. | 02556707 | Tablet - Oral | 2.5 MG | N/A |
NB-AMLODIPINE | nb pharma inc. | 02556723 | Tablet - Oral | 10 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
VIACORLIX 7 MG/5 MG/2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 83231 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
VIACORLIX 7 mg/5 mg/2,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 180074IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
PERINDOPRIL/AMLODIPINO/INDAPAMIDA KRKA 7 MG/5 MG/2,5 MG COMPRIMIDOS EFG | Krka D.D. Novo Mesto | 90226 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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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