Norvasc
(Amlodipine)ApprovedSmall molecule
Amlodipine is used to treat high blood pressure and chest pain (angina) by relaxing blood vessels and improving blood flow.[2] Norvasc is currently approved and in use across 45 indications[4].[1]
Norvasc is one of 947 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.
45
Indications
236
Total Trials
8
Active Trials
946
Competitors
6
FDA Applications
NDA/BLA/ANDA regulatory filings
19
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 45 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Norvasc
VViatris Specialty LLC
Approved
Tykerb
GSKPreclinical
Prolia
AmgenPreclinical
Gemzar
GGynecologic Oncology Group
Preclinical
DATROWAY
Daiichi SankyoPreclinical
Cymbalta
Alnylam PharmaceuticalsPreclinical
Spravato
WWim Janssens
Preclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Vfend
PPrism Pharmaceuticals
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Hypertension52 trials
Show 49 more trials
Black Education and Treatment of Hypertension (BEAT HTN)
Completed·—·Phase 4·NCT00661895·99 enrolled
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00174330·330 enrolled
Anti Inflammatory Treatment of Hypertension
Completed·—·Phase 2/3·NCT04740840·200 enrolled
Amlodipine Diabetic Hypertension Efficacy Response Trial
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00159692·739 enrolled
Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension
Completed·—·Phase 4·NCT02973035·104 enrolled
Essential Hypertension21 trials
Show 18 more trials
Intensive Vasodilator Therapy in Patients With Essential Hypertension
Completed·—·Phase 4·NCT01180413·48 enrolled
Interaction10 trials
Show 7 more trials
Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00039975·32 enrolled
Blood Pressure7 trials
N-of-1 Trials for Blood Pressure Medications in Adults
Completed·—·Phase 1·NCT02744456·10 enrolled
Show 4 more trials
Skin Sodium and Salt Sensitivity of Blood Pressure
Unknown status·—·N/A·NCT05976438·60 enrolled
Hypertensive7 trials
62 more indications
AML6 trials
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Completed·—·Phase 1·NCT01131936·24 enrolled
Show 3 more trials
Tics6 trials
Safety and Efficacy5 trials
Type 2 Diabetes4 trials
Trial4 trials
Efficacy and Safety4 trials
Show 1 more trial
ART4 trials
Fasting Conditions3 trials
High Blood Pressure3 trials
Atorvastatin3 trials
Thalassemia3 trials
Effectiveness2 trials
Ischemic stroke2 trials
Biomarkers2 trials
Obesity2 trials
Metabolic Syndrome2 trials
Sleep Apnea2 trials
Cardiovascular1 trial
CAR1 trial
Newly Diagnosed1 trial
Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
Completed·—·Phase 4·NCT05467384·80 enrolled
Mortality1 trial
Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure
Completed·—·Phase 4·NCT00124969·356 enrolled
Platelet Reactivity1 trial
Glucose intolerance1 trial
Beta-Thalassemia1 trial
LSD1 trial
MR Antagonist and LSD1
Active, not recruiting·—·Phase 4·NCT04840342·300 enrolled
Endothelial Dysfunction1 trial
Oral1 trial
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01004614·48 enrolled
Primary Aldosteronism1 trial
Calcium Channel Blockade in Primary Aldosteronism
Completed·—·Phase 2·NCT04179019·15 enrolled
Lower Urinary Tract Symptom1 trial
Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension
Completed·—·N/A·NCT00693199·360 enrolled
Proteinuria1 trial
Elderly Patients1 trial
Alcoholic Fatty Liver Disease1 trial
Kidney Disease1 trial
African American Study of Kidney Disease and Hypertension
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT04364139·1,094 enrolled
Insulin Sensitivity1 trial
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
Terminated·—·N/A·NCT01252238·24 enrolled
Double-blind1 trial
Diabetes Mellitus1 trial
Type 1 Diabetes1 trial
Microvascular Function1 trial
Randomized Controlled Trial1 trial
Vascular Inflammation1 trial
Combination Therapy1 trial
Efficacy1 trial
Frozen Embryo Transfer1 trial
Pancreatitis1 trial
Breast Cancer1 trial
Heart Attack1 trial
Unspecified2 trials
Regulatory
FDA Approval Timeline[5]
Jul 31, 1992
NORVASC
NDA NDA019787
Oct 31, 2003
AMVAZ
NDA NDA021435
Sep 27, 2007
AMLODIPINE BESYLATE
NDA NDA022026
Jul 8, 2019
KATERZIA
NDA NDA211340
Feb 24, 2022
NORLIQVA
NDA NDA214439
Jul 24, 2025
SDAMLO
NDA NDA219531
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Norvasc drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Amlodipine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Voltage-Gated L-Type Calcium Channel Blocker[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- VViatris Specialty LLC