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Amlodipine

Generic Name
Amlodipine
Brand Names
Amlobenz, Azor, Caduet, Dafiro, Exforge, Exforge Hct, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Tribenzor, Twynsta, Viacoram
Drug Type
Small Molecule
Chemical Formula
C20H25ClN2O5
CAS Number
88150-42-9
Unique Ingredient Identifier
1J444QC288

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

Published: Jul 11, 2025

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.

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2009/07/13
Phase 1
Completed
2009/07/09
N/A
UNKNOWN
2009/07/03
Phase 1
Completed
2009/07/03
Phase 1
Completed
2009/06/16
Phase 4
Completed
Gulhane School of Medicine
2009/05/01
Phase 3
Completed
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
2009/04/08
Phase 3
Completed
2009/03/27
Phase 1
Completed
2009/03/27
Phase 1
Completed
2009/03/12
Phase 3
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
71335-0934
ORAL
5 mg in 1 1
9/28/2022
Northwind Pharmaceuticals, LLC
51655-291
ORAL
5 mg in 1 1
4/17/2023
Zydus Pharmaceuticals (USA) Inc.
68382-428
ORAL
5 mg in 1 1
10/31/2020
Physicians Total Care, Inc.
54868-5523
ORAL
10 mg in 1 1
11/30/2009
Novartis Pharmaceuticals Corporation
0078-0562
ORAL
10 mg in 1 1
6/12/2019
Aidarex Pharmaceuticals LLC
33261-826
ORAL
2.5 mg in 1 1
11/20/2013
Lupin Pharmaceuticals, Inc.
68180-755
ORAL
2.5 mg in 1 1
1/29/2024
Mylan Pharmaceuticals Inc.
0378-4515
ORAL
5 mg in 1 1
1/26/2022
A-S Medication Solutions
50090-1039
ORAL
5 mg in 1 1
11/10/2021
RPK Pharmaceuticals, Inc.
53002-1804
ORAL
10 mg in 1 1
11/10/2021

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
COVERAM 5/10 perindopril arginine 5mg/ amlodipine (as besilate) 10mg uncoated tablet bottle
154439
Medicine
A
1/11/2010
EXFORGE HCT 10/320/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
158168
Medicine
A
4/9/2010
OLMESARTAN/AMLODIPINE SPR 20/5 olmesartan medoxomil 20 mg and amlodipine (as besilate) 5 mg tablet bottle
218243
Medicine
A
1/12/2016
CHEMMART Perindopril Arginine/Amlodipine 10/5 perindopril arginine 10 mg and amlodipine (as besilate) 5 mg uncoated tablet blister pack
224311
Medicine
A
1/12/2016
APO-AMLODIPINE/VALSARTAN 5/80 amlodipine besilate 5 mg and valsartan 80 mg tablet bottle
205664
Medicine
A
11/11/2013
APOTEX-AMLODIPINE/VALSARTAN 10/160 amlodipine besilate 10 mg and valsartan 160 mg tablet blister pack
205682
Medicine
A
11/11/2013
APOTEX-AMLODIPINE/VALSARTAN 5/160 amlodipine besilate 5 mg and valsartan 160 mg tablet blister pack
205658
Medicine
A
11/11/2013
CHEMMART AMLODIPINE/VALSARTAN 5/80 amlodipine besilate 5 mg and valsartan 80 mg tablet blister pack
205659
Medicine
A
11/11/2013
OLMEKAR 20/10 olmesartan medoxomil 20 mg/ amlodipine (as besilate) 10 mg tablet blister pack
290079
Medicine
A
6/13/2018
OLMESARTAN/ AMLODIPINE HCT - MYL 40/10/25 olmesartan medoxomil 40mg, amlodipine (as besilate) 10mg + hydrochlorothiazide 25mg tablet blister pack
273596
Medicine
A
6/7/2016

Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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MA Holder
MA Number
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