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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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/24
Phase 2
Not yet recruiting
2024/12/03
Phase 4
Withdrawn
2024/07/26
Phase 4
Recruiting
2024/06/18
Phase 3
Completed
2024/05/22
Phase 2
Recruiting
2024/05/02
Phase 3
Completed
Oslo University Hospital
2024/02/14
N/A
Completed
2024/01/05
Phase 1
Not yet recruiting
International Bio service
2023/11/29
Phase 3
Recruiting
2023/08/04
Not Applicable
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Par Pharmaceutical, Inc.
49884-786
ORAL
5 mg in 1 1
10/10/2023
ScieGen Pharmaceuticals, Inc
50228-368
ORAL
10 mg in 1 1
12/10/2018
Dr. Reddy's Laboratories Inc
43598-318
ORAL
10 mg in 1 1
2/16/2021
Alembic Pharmaceuticals Inc.
62332-755
ORAL
2.5 mg in 1 1
5/23/2025
Mylan Pharmaceuticals Inc.
0378-4513
ORAL
5 mg in 1 1
1/26/2022
Quality Care Products, LLC
83008-039
ORAL
10 mg in 1 1
8/18/2023
Northwind Pharmaceuticals, LLC
51655-044
ORAL
5 mg in 1 1
1/1/2024
Marlex Pharmaceuticals, Inc.
10135-759
ORAL
2.5 mg in 1 1
10/15/2022
Bryant Ranch Prepack
71335-1278
ORAL
5 mg in 1 1
3/29/2023
Dr. Reddy's Laboratories Inc
43598-320
ORAL
2.5 mg in 1 1
2/16/2021

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Amlodipine Besilate Capsules
国药准字H20030576
化学药品
胶囊剂
8/11/2020
Amlodipine Besilate Capsules
国药准字H20030289
化学药品
胶囊剂
6/12/2020
Amlodipine Mesylate Tablets
国药准字H20000708
化学药品
片剂
4/23/2020
Amlodipine Maleate Pills
国药准字H20080767
化学药品
滴丸剂
7/15/2023
Amlodipine Besylate Pills
国药准字H20080728
化学药品
滴丸剂
6/1/2023
Aspartic acid Amlodipine Tablets
国药准字H20020487
化学药品
片剂
3/23/2023
Amlodipine Maleate Tablets
国药准字H20113392
化学药品
片剂
3/25/2021
Amlodipine Maleate Tablets
国药准字H20050587
化学药品
片剂
3/24/2020
Amlodipine Maleate Tablets
国药准字H20010073
化学药品
片剂
2/26/2020
Amlodipine Maleate Tablets
国药准字H20020419
化学药品
片剂
1/8/2020

PPB Drug Approvals

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

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
TELMISARTAN/AMLODIPINE APOTEX 40/5 telmisartan/amlodipine (as besilate) 40/5 mg tablet blister pack
276151
Medicine
A
6/16/2017
APO-AMLODIPINE/VALSARTAN 5/160 amlodipine besilate 5 mg and valsartan 160 mg tablet blister pack
205685
Medicine
A
11/11/2013
APOTEX-AMLODIPINE/VALSARTAN 5/80 amlodipine besilate 5 mg and valsartan 80 mg tablet blister pack
205681
Medicine
A
11/11/2013
TERRY WHITE CHEMISTS AMLODIPINE/VALSARTAN 5/80 amlodipine besilate 5 mg and valsartan 80 mg tablet blister pack
205657
Medicine
A
11/11/2013
TWYNSTA 40/10 telmisartan 40 mg/amlodipine 10 mg (as besilate) tablet blister pack
166264
Medicine
A
2/18/2011
EXFORGE HCT 5/160/12.5 amlodipine/valsartan/hydrochlorothiazide combination tablet blister pack
157954
Medicine
A
4/9/2010
APO-TELMISARTAN/AMLODIPINE 80/5 telmisartan/amlodipine (as besilate) 80/5 mg tablet blister
276426
Medicine
A
7/26/2017
Perindopril Arginine/Amlodipine 10/10 APOTEX perindopril arginine 10 mg and amlodipine (as besilate) 10 mg uncoated tablet bottle
224335
Medicine
A
1/12/2016
OLMESARTAN AMLO HCT GPPL 40/5/12.5 olmesartan medoxomil/amlodipine (as besilate) and hydrochlorothiazide 40 mg/5 mg/12.5 mg tablet blister pack
288835
Medicine
A
4/23/2018
OLMESART AMLODIPINE 20/5 olmesartan medoxomil 20 mg / amlodipine (as besilate) 5 mg tablet blister pack
290092
Medicine
A
6/13/2018

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