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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, Amlodipine / Valsartan Mylan
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
2006/08/24
Phase 3
Completed
2006/08/04
Phase 3
Completed
2006/07/12
Phase 4
Completed
2006/06/20
Phase 4
Completed
2006/06/15
Not Applicable
Completed
2006/06/02
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2006/05/18
Phase 3
Completed
2006/05/18
Phase 3
Completed
2006/03/17
Phase 4
Completed
2006/02/09
Phase 3
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Alembic Pharmaceuticals Limited
46708-461
ORAL
10 mg in 1 1
1/27/2023
Pfizer Laboratories Div Pfizer Inc
0069-2150
ORAL
5 mg in 1 1
8/30/2023
Daiichi Sankyo, Inc.
65597-118
ORAL
10 mg in 1 1
6/7/2022
NuCare Pharmaceuticals,Inc.
68071-2305
ORAL
10 mg in 1 1
8/16/2022
Strides Pharma Science Limited
64380-201
ORAL
10 mg in 1 1
8/31/2022
Rising Health, LLC
57237-142
ORAL
2.5 mg in 1 1
1/14/2022
RedPharm Drug, Inc.
67296-1530
ORAL
10 mg in 1 1
1/21/2022
Bryant Ranch Prepack
71335-1032
ORAL
2.5 mg in 1 1
12/22/2017
Alembic Pharmaceuticals Inc.
62332-759
ORAL
5 mg in 1 1
5/23/2025
Central Texas Community Health Centers
76413-141
ORAL
5 mg in 1 1
5/26/2016

EMA Drug Approvals

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HSA 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
APO-AMLODIPINE/VALSARTAN 10/160 amlodipine besilate 10 mg and valsartan 160 mg tablet bottle
205679
Medicine
A
11/11/2013
AMLODIPINE RAN amlodipine (as besilate) 10 mg tablet blister pack
195704
Medicine
A
1/7/2013
GenRx Perindopril Arginine/Amlodipine 10/5 perindopril arginine 10 mg and amlodipine (as besilate) 5 mg uncoated tablet bottle
224294
Medicine
A
1/12/2016
APO-Perindopril Arginine/Amlodipine 10/5 perindopril arginine 10 mg and amlodipine (as besilate) 5 mg uncoated tablet bottle
224316
Medicine
A
1/12/2016
AMLODIPINE RBX amlodipine (as besilate) 5 mg tablet blister pack
195701
Medicine
A
1/7/2013
OLMEKAR 20/5 olmesartan medoxomil 20 mg / amlodipine (as besilate) 5 mg tablet blister pack
290077
Medicine
A
6/13/2018
OLMES AMLO HCT 40/10/25 olmesartan medoxomil/amlodipine (as besilate) and hydrochlorothiazide 40 mg/10 mg/25 mg tablet blister pack
288855
Medicine
A
4/23/2018
Twynipine 80/5 telmisartan/amlodipine (as besilate) 80/5 mg tablet blister pack
276006
Medicine
A
6/16/2017
AKM Olmesartan Amlodipine 40/10 olmesartan medoxomil 40 mg / amlodipine (as besilate) 10 mg tablets blister pack
302284
Medicine
A
12/17/2019
OLAMLO HCT 40/5/25 olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/5/25 mg film-coated tablet blister pack
312005
Medicine
A
11/21/2019

Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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

Philippines FDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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