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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
2013/02/25
Phase 1
Completed
2013/01/25
Phase 1
Completed
2013/01/07
Not Applicable
Completed
Sogo Rinsho Médéfi Co., Ltd.
2012/11/30
Phase 4
Completed
Gulhane School of Medicine
2012/10/25
Phase 4
Completed
Sang Hyun Ihm, MD PhD
2012/09/25
Phase 2
Completed
2012/08/15
Not Applicable
UNKNOWN
2012/08/13
Phase 3
Completed
2012/08/07
Not Applicable
Completed
2012/07/30
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Rising Health, LLC
57237-146
ORAL
10 mg in 1 1
1/14/2022
Alembic Pharmaceuticals Limited
46708-765
ORAL
10 mg in 1 1
5/23/2025
State of Florida DOH Central Pharmacy
53808-1029
ORAL
5 mg in 1 1
12/7/2014
Macleods Pharmaceuticals Limited
33342-193
ORAL
10 mg in 1 1
11/14/2022
Alembic Pharmaceuticals Limited
46708-459
ORAL
10 mg in 1 1
1/27/2023
A-S Medication Solutions
50090-3404
ORAL
5 mg in 1 1
5/18/2017
Bi‐Coastal Pharma International LLC
42582-314
ORAL
5 mg in 1 1
1/9/2019
A-S Medication Solutions
50090-1527
ORAL
5 mg in 1 1
3/11/2020
St. Mary's Medical Park Pharmacy
60760-132
ORAL
10 mg in 1 1
12/14/2020
State of Florida DOH Central Pharmacy
53808-0686
ORAL
10 mg in 1 1
8/9/2013

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