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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
2005/09/15
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2005/09/15
Phase 4
Completed
2005/09/12
Phase 1
Completed
2005/09/12
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2005/09/12
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2005/09/09
Phase 2
Terminated
Rennes University Hospital
2005/09/02
Phase 4
Completed
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2005/08/31
Phase 4
Completed
2005/08/29
Phase 4
Completed
2005/08/29
Phase 4
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Unichem Pharmaceuticals (USA), Inc.
29300-398
ORAL
10 mg in 1 1
12/5/2022
Daiichi Sankyo, Inc.
65597-114
ORAL
5 mg in 1 1
6/7/2022
Proficient Rx LP
71205-596
ORAL
5 mg in 1 1
6/1/2022
NuCare Pharmaceuticals,Inc.
68071-4870
ORAL
5 mg in 1 1
4/25/2019
Lupin Pharmaceuticals, Inc.
68180-721
ORAL
10 mg in 1 1
1/12/2024
NuCare Pharmaceuticals,Inc.
68071-2312
ORAL
5 mg in 1 1
9/7/2022
Zydus Lifesciences Limited
65841-621
ORAL
5 mg in 1 1
9/18/2023
Legacy Pharmaceutical Packaging, LLC
68645-516
ORAL
10 mg in 1 1
12/8/2023
Zydus Pharmaceuticals (USA) Inc.
68382-432
ORAL
10 mg in 1 1
10/31/2020
Apotex Corp.
60505-3488
ORAL
5 mg in 1 1
2/24/2023

EMA Drug Approvals

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Approved Product
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.
Strength
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
CADIVAST 10/40 amlodipine (as besilate) and atorvastatin (as calcium) 10 mg/40 mg tablets bottle
199225
Medicine
A
1/9/2014
CADIVAST 5/10 amlodipine (as besilate) and atorvastatin (as calcium) 5 mg/10 mg tablets bottle
199213
Medicine
A
1/9/2014
OLMESARTAN/ AMLODIPINE HCT - MYL olmesartan medoxomil 20mg, amlodipine (as besilate) 5mg and hydrochlorothiazide 12.5mg tablet blister pack
273592
Medicine
A
6/7/2016
SEVIKAR HCT 40/10/12.5 olmesartan medoxomil 40 mg amlodipine (as besilate) 10 mg and hydrochlorothiazide 12.5mg tablet blister pack
199005
Medicine
A
9/20/2013
APOTEX-AMLODIPINE/VALSARTAN 10/320 amlodipine besilate 10 mg and valsartan 320 mg tablet blister
205652
Medicine
A
11/11/2013
APO-AMLODIPINE amlodipine 2.5 mg (as besilate) tablet blister pack
135120
Medicine
A
12/13/2007
EXFORGE 5/160 amlodipine 5mg (as besilate)/valsartan 160mg film-coated tablets blister pack
130834
Medicine
A
2/5/2008
TELMISARTAN/AMLODIPINE APOTEX 80/5 telmisartan/amlodipine (as besilate) 80/5 mg tablet blister pack
276149
Medicine
A
6/16/2017
Amlo-Telmisartan 40/10 telmisartan/amlodipine (as besilate) 40/10 mg tablet blister pack
276207
Medicine
A
6/16/2017
Amlo-Telmisartan 80/10 telmisartan/amlodipine (as besilate) 80/10 mg tablet blister pack
276190
Medicine
A
6/16/2017

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