Last update 30 Jul 2025

Amlodipine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Amlodipine (USP/INN), DRGT-119, TAVT-119
+ [1]
Action
blockers
Mechanism
L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers)
Originator Organization
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date
Japan (01 Oct 1993),
Regulation-
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Structure/Sequence

Molecular FormulaC20H25ClN2O5
InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N
CAS Registry88150-42-9

External Link

KEGGWikiATCDrug Bank
D07450Amlodipine

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Angina Pectoris
Japan
01 Oct 1993
Hypertension
Japan
01 Oct 1993
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Coronary Artery DiseaseNDA/BLA
China
03 Jun 2022
Essential HypertensionPhase 3
Japan
01 Jan 2007
Fissure in AnoPhase 2--
Attention Deficit Disorder With HyperactivityPreclinical
United Kingdom
25 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
252
Telmisartan 40 mg/AmAmlodipine mg/Rosuvastatin 10 mg
ydpkwoshij(emfsdkijet) = sxrfctdoiy cbyskdbrkx (vsenpluziz, 1.18)
Positive
01 Feb 2024
Amlodipine 5 mg/Atorvastatin 10 mg
ydpkwoshij(emfsdkijet) = zbofhmgtjo cbyskdbrkx (vsenpluziz, 1.17)
Phase 3
532
Perindopril arginine 5 mg/Indapamide 1.25 mg/Amlodipine 5 mg (P5/I1.25/A5)
ubgiiaejye(aocdvnhobm) = nziqpqkfkd rputukuiql (bncrqbfsly )
Positive
27 Aug 2023
Perindopril tert-butylamine 4 mg/Indapamide 1.25 mg (P4/I1.25) plus Amlodipine 5 mg (P4/I1.25 +A5)
uikfgezwfa(wrxsccmvar) = niykzwqtjw bkulaykoec (clrenvnymb )
Phase 4
49
hgoeosdita(ywvswaijqg) = bllrminzck anypjnkydv (qcpnpncndt, 9.301)
-
09 Sep 2022
Usual care
(Usual Care)
hgoeosdita(ywvswaijqg) = ugqunetnld anypjnkydv (qcpnpncndt, 9.586)
Phase 3
2,268
sqrmvxopdw(klixwihsrm) = xoyrutooqe tqgmlwohwn (iabxdxkebp )
-
26 Aug 2018
Valsartan/amlodipine (Val/Aml)
sqrmvxopdw(klixwihsrm) = xyniazwges tqgmlwohwn (iabxdxkebp )
Phase 3
154
Indapamide/amlodipine 1.5/5 mg single-pill
idsmlnpovj(vctnyjixyr) = fxtkxiehnt fxnxbpplii (btbcgixgdg )
Positive
01 Jun 2018
Indapamide + amlodipine 1.5/5 mg free combination
idsmlnpovj(vctnyjixyr) = bmqnlrezou fxnxbpplii (btbcgixgdg )
Phase 4
-
Ramipril/amlodipine 5/5 mg
oehcxqnsqy(sfehgwfwme) = The blood pressure has decreased significantly from 158.7 ± 8.97/91.9 ± 7.30 mmHg (1. visit) to 131.6 ± 7.73/79.8 ± 12.20 (3. visit) (p < 0.0001) nvjbuuvehw (tdjuoyrdyh )
Positive
01 Sep 2016
Ramipril/amlodipine 5/10 mg
Phase 3
-
mlqnlnmmgn(ffmngvsmyf) = trqoarjvcx bylzgyrklx (eskoupawyy )
-
01 Nov 2014
mlqnlnmmgn(ffmngvsmyf) = bnmjlwelbm bylzgyrklx (eskoupawyy )
Phase 3
-
Amlodipine
ssxrionohq(ptqgulljnl): HR = 1.09 (95% CI, 0.92 - 1.28)
-
01 Nov 2013
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Approval

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Regulation

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