TheraRadar
Data updated: May 26, 2026

NORLIQVA (amlodipine besylate)

Calcium Channel Antagonists Trial Activity: Declining 9 active trials
Cardiovascular Approved 2022-02-24

NORLIQVA is indicated for the treatment of Hypertension; Coronary Artery Disease; Chronic Stable Angina; Vasospastic Angina.

Source: FDA Label • CMP DEV LLC • Dihydropyridine Calcium Channel Blocker
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How NORLIQVA Works

Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It exhibits greater selectivity for vascular smooth muscle cells than for cardiac muscle cells. As a peripheral arterial vasodilator, it acts directly on vascular smooth muscle to reduce peripheral vascular resistance and lower blood pressure. In the treatment of angina, it

Source: FDA Label

Development Insights

Novartis Pharmaceuticals conducting 11 trials (12%)
56 indications explored (Broad Platform)
→ hypertension (51 trials)
→ essential hypertension (6 trials)
→ healthy (5 trials)
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-02-24
Patent Cliff
2041

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

CMP DEV LLC
Active Ingredient: AMLODIPINE BESYLATE

NORLIQVA Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2026
Feb 2026 SUPPL
Label · Labeling
Label
Feb 2022 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What NORLIQVA Treats

4 indications

NORLIQVA is approved for 4 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Coronary Artery Disease
  • Chronic Stable Angina
  • Vasospastic Angina
Source: FDA Label

NORLIQVA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

8

Same target(s) AND same indication — head-to-head.

NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
INFORLIFE
2024 2 indic.
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
INFORLIFE
2024 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JAVADIN
AZURITY
2025 3 indic.
VOSTALLY
ROSEMONT PHARMS
2025 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NORLIQVA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SDAMLO
AMLODIPINE BESYLATE
4 shared
BRILLIAN PHARMA
Shared indications:
HypertensionCoronary Artery DiseaseChronic Stable Angina +1 more
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AMLODIPINE BESYLATE
2 shared
Apotex
Shared indications:
HypertensionCoronary Artery Disease
AMLODIPINE BESYLATE AND VALSARTAN
AMLODIPINE BESYLATE
2 shared
Viatris
Shared indications:
HypertensionCoronary Artery Disease
View all 20 similar drugs Pro
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Clinical Trial Registry

98 trials
Trial Sponsor ID Phase Status Title
NCT07564726 CTP-EAR 3.1 Ph 3 completed Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
NCT04840342 2021p000990 Ph 4 active not recruiting MR Antagonist and LSD1
NCT01120327 Amlodipine study Ph 4 completed A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
NCT05312892 212413 Ph 1, Ph 2 recruiting Sympathetic Mechanisms in Obesity-Crossover Design
NCT04434664 BLOCK HFpEF results posted 833517 Ph 4 completed BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
NCT07075965 CAP DM1 STUDY00010646 Ph 1 not yet recruiting Calcium Channel Blocker in Myotonic Dystrophy Type 1
NCT07241338 SHOT 2025PHB414 Ph 4 not yet recruiting Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity
NCT05103332 KARDIA-2 results posted ALN-AGT01-003 2021-003776-13 Ph 2 completed Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
NCT02847338 AIMHY-INFORM AO94005 Ph 4 completed Comparison of Optimal Hypertension Regimens
NCT06150560 VALUE 23-007629 1R01HL162830-01A1 Ph 3 recruiting A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
NCT02373163 INTERVENCION results posted INTERVENCION Trial Ph 4 completed INTERVENCION Trial
NCT06942377 Peking University Ph 2 not yet recruiting Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
NCT04179019 CCB-PA results posted 2019P003194 Ph 2 completed Calcium Channel Blockade in Primary Aldosteronism
NCT04974138 CSPPT2-CC/CT CSPPT2-CC/CT_2020 Ph 4 recruiting China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
NCT04974151 CSPPT2-TT CSPPT2-TT_2020 Ph 4 recruiting China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
NCT05513937 Botticelli results posted MEIN/21/AmNe-Hyp/001 Ph 4 completed Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy
NCT06713785 PERSONAL HTN 1 Ph 4 withdrawn Personalised Electronic Record Supported Optimisation of Amlodipine for Patients With Hypertension
NCT06424834 MVP-ANOCA IRB-75085 24POST1189688 Ph 2, Ph 3 recruiting Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
NCT04790279 results posted Pro00106643 Ph 4 completed Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension
NCT05279807 Masolino results posted MEIN/20/ZoAm-Hyp/001 Ph 4 completed Effectiveness and Safety of Combination of Amlodipine and Zofenopril in Hypertensive Patients Versus Each Monotherapy
NCT05917275 HT-PREDICT 114516 2023-505239-10-00 Ph 4 recruiting Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
NCT04559074 PERSONALCovdBP 283209 PERSONAL-Covid BP, 2020-002494-10 Ph 4 completed Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension
NCT05416840 ECLIPSE 20220001 Ph 4 not yet recruiting Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension
NCT02834403 results posted Pro00011685 Ph 1, Ph 2 completed L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
NCT05275907 STU00215781 1R56HL155093-01 Ph 4 withdrawn Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)
NCT05663073 HD-AI-101 Ph 1 completed Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
NCT05688085 HD-AI-103 Ph 1 completed Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
NCT03082014 TREAT-SVDs TRE-1486--0105-I Ph 3 terminated Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function
NCT03461003 NICHE results posted HSC-MS-17-1014 UL1TR003167 Ph 4 completed N-of-1 Trials In Children With Hypertension
NCT04978649 GDPH-IPAD-CKD Ph 4 withdrawn Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy
NCT05467384 sashah0002 Ph 4 completed Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
NCT03897868 HM_APOLLO HM-APOLLO-201 Ph 2 completed A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
NCT02940548 NARRAS 2016PHB013-02 Ph 4 terminated Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
NCT01996449 results posted R01HL113738 Ph 2 completed The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension
NCT04121299 IRB-300004152 Ph 3 withdrawn Mechanism of Masked Hypertension - Intervention
NCT00667719 results posted CSAH100A2301 2008-001242-10 Ph 3 completed A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
NCT04740840 AHNorthSichuanMC Ph 2, Ph 3 completed Anti Inflammatory Treatment of Hypertension
NCT01004614 results posted A0531088 Ph 1 completed Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
NCT02034435 results posted 131139 Ph 4 completed Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
NCT04074551 HM-AMOS-301 Ph 3 completed A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
NCT00765947 results posted CSPP100A2360 Ph 4 completed Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
NCT02973035 YMC016 Ph 4 completed Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension
NCT01302691 results posted 0954E-357 Ph 3 completed MK-0954E Study in Participants With Hypertension (MK-0954E-357)
NCT03226275 results posted EMR200006-001 Ph 1 completed Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants
NCT02353806 results posted 042014-059 UL1TR001105 Ph 4 completed Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
NCT00649389 results posted CS8635-A-U301 Ph 3 completed Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
NCT02058823 IH2 2011-32 P-2011-32-HI2 Ph 4 terminated Intermittent Hypoxia 2: Cardiovascular and Metabolism
NCT00891267 VAMOS DSE-866/46 2007-003130-41 EudraCT number Ph 3 completed Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
NCT01337674 results posted 4618-010 Ph 1 completed Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
NCT01264692 REDUCE-1 AC-067A201 Ph 2 completed Essential Hypertension

Showing 50 of 98 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NORLIQVA FDA Label Details

Indications & Usage

FDA Label (PDF)

NORLIQVA is indicated for the treatment of Hypertension; Coronary Artery Disease; Chronic Stable Angina; Vasospastic Angina.

View full patent landscape →
6 OB patents · 1 families · 12 international docs across 1 countries

NORLIQVA Patents & Exclusivity

Latest Patent: Feb 2041

Patents (6 active)

US12226528 Expires Feb 24, 2041
US11458095 Expires Feb 24, 2041
US12005141 Expires Feb 24, 2041
US12440441 Expires Feb 24, 2041
US11723866 Expires Feb 24, 2041
US11253474 Expires Feb 24, 2041
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for NORLIQVA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 18 active patents

Trial Analysis

  • • 93 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA214439 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment