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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
2006/12/29
Phase 2
Completed
2006/12/25
Phase 3
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2006/12/19
Phase 3
Completed
2006/12/15
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2006/12/11
Phase 3
Completed
2006/12/05
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2006/11/22
Phase 3
Completed
2006/09/29
Not Applicable
Completed
2006/08/24
Phase 4
Completed
2006/08/24
Phase 3
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
70934-075
ORAL
5 mg in 1 1
1/2/2023
Pfizer Laboratories Div Pfizer Inc
0069-6180
ORAL
5 mg in 1 1
8/30/2023
Alembic Pharmaceuticals Inc.
62332-205
ORAL
5 mg in 1 1
2/24/2023
Zydus Lifesciences Limited
70771-1464
ORAL
10 mg in 1 1
10/13/2022
Bryant Ranch Prepack
63629-2238
ORAL
5 mg in 1 1
5/26/2021
Proficient Rx LP
71205-122
ORAL
5 mg in 1 1
11/1/2022
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-846
ORAL
5 mg in 1 1
2/10/2023
STAT RX USA LLC
16590-295
ORAL
5 mg in 1 1
3/12/2010
Quallent Pharmaceuticals Health LLC
82009-028
ORAL
10 mg in 1 1
9/15/2023
medsource pharmaceuticals
45865-935
ORAL
5 mg in 1 1
12/26/2018

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
REAPTAN 5/5 perindopril arginine 5mg/ amlodipine (as besilate) 5mg tablet bottle
170796
Medicine
A
11/4/2010
AMLOZIC amlodipine (as besilate) 10 mg tablet blister pack
151430
Medicine
A
6/25/2009
TELMISARTAN/ AMLODIPINE MYLAN 80/5 MYLAN telmisartan/ amlodipine (as besilate) 80/5mg film-coated tablet bottle
234920
Medicine
A
1/19/2022
AMLODIPINE/VALSARTAN NOVARTIS 10/160 amlodipine 10 mg/valsartan 160 mg film-coated tablet blister pack
151628
Medicine
A
8/12/2008
AMLODIPINE/VALSARTAN NOVARTIS 5/80 amlodipine 5 mg/valsartan 80 mg film-coated tablet blister pack
151626
Medicine
A
8/12/2008
APO-AMLODIPINE/VALSARTAN 10/160 amlodipine besilate 10 mg and valsartan 160 mg tablet blister pack
205680
Medicine
A
11/11/2013
CADIVAST 10/10 amlodipine (as besilate) and atorvastatin (as calcium) 10 mg/10 mg tablets bottle
199215
Medicine
A
1/9/2014
AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
158165
Medicine
A
4/9/2010
CADIVAST 5/40 amlodipine (as besilate) and atorvastatin (as calcium) 5 mg/40 mg tablets bottle
199214
Medicine
A
1/9/2014
GENEPHARM AMLODIPINE amlodipine 2.5 mg (as besilate) tablet blister pack
146236
Medicine
A
12/13/2007

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