Amlodipine
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1992
- First approval year
- 1992
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Amlodipine
- Molecular weight
- 408.88
- Structure (SMILES)
- CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
- astudal 5
- Astudal 5
- istin
- Istin
- norvas
- Norvas
- norvasc
- Norvasc
- 3 5 pyridinedicarboxylic acid 2 2 aminoethoxy methyl 4 2 chlorophenyl 1 4 dihydro 6 methyl 3 ethyl 5 methyl ester
- 3 ethyl 5 methyl 2 2 aminoethoxy methyl 4 o chlorophenyl 1 4 dihydro 6 methyl 3 5 pyridinedicarboxylate
- 3-ETHYL 5-METHYL (±)-2-((2-AMINOETHOXY)METHYL)-4-(O-CHLOROPHENYL)-1,4-DIHYDRO-6-METHYL-3,5-PYRIDINEDICARBOXYLATE
- 3,5-PYRIDINEDICARBOXYLIC ACID, 2-((2-AMINOETHOXY)METHYL)-4-(2-CHLOROPHENYL)-1,4-DIHYDRO-6-METHYL-, 3-ETHYL 5-METHYL ESTER, (±)-
- amlodipine
- Amlodipine
- AMLODIPINE [EMA EPAR]
- amlodipine [INN]
- AMLODIPINE [MART.]
- AMLODIPINE [MI]
- AMLODIPINE [ORANGE BOOK]
- AMLODIPINE [VANDF]
- Amlodipine [WHO-DD]
- amlodipine component of ckd 330
- AMLODIPINE COMPONENT OF CKD-330
- amlodipine ema epar
- amlodipine inn
- amlodipine mart
- amlodipine mi
- amlodipine orange book
- amlodipine vandf
- amlodipine who dd
- amlodipino
- Amlodipino
- ckd 330 component amlodipine
And 5 more, listed on the interactive page.
- ATC classification codes
- C08CA01
Sources for recorded values
- CAS registry numbers
- 88150-42-9
- ChEMBL ID
- CHEMBL1491
- InChIKey
- HTIQEAQVCYTUBX-UHFFFAOYSA-N
- PubChem compound IDs
- 2162
- FDA ingredient codes (UNII)
- 1J444QC288
- 17767
- 104416
- Applicant
- CMP DEV LLC
- Approval date
- 24 Feb 2022
- Application number
- NDA214439
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- amlodipine
- Type
- Synthetic organic
- Drug name stem
- -dipine; -pine
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Cav1.3
- Gene symbol
- CACNA1D
- Protein identifier
- Q01668
- Median affinity
- 7.2
- Affinity units
- pIC50
- Action
- Negative
- Action type
- NEGATIVE
- Target
- P2X4
- Gene symbol
- P2RX4
- Protein identifier
- Q99571
Open Targets mechanisms
- Mechanism
- Voltage-gated L-type calcium channel blocker
- Action type
- Blocker
- Target
- Voltage-gated L-type calcium channel
- Action type
- Blocker
- Gene symbol
- CACNA1D
- Protein identifier
- Q01668
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Blocker
- Gene symbol
- CACNA1C
- Protein identifier
- Q13936
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Pancreatitis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000278
- Subject identifier
- D010195
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Heart Failure
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Hypertension
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Cardiomyopathy, Hypertrophic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000538
- Subject identifier
- D002312
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Liver Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Kidney Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Heart Failure
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Heart Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003777
- Subject identifier
- D006331
- Condition
- Atherosclerosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Aortic Aneurysm, Abdominal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004214
- Subject identifier
- D017544
- Condition
- Erectile Dysfunction
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004234
- Subject identifier
- D007172
- Condition
- Vascular Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004264
- Subject identifier
- D014652
- Condition
- Aortic Valve Insufficiency
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007148
- Subject identifier
- D001022
- Condition
- Raynaud Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001145
- Subject identifier
- D011928
- Condition
- Myocardial Ischemia
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001375
- Subject identifier
- D017202
- Condition
- Thalassemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001996
- Subject identifier
- D013789
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Dystonic Disorders
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000477
- Subject identifier
- D020821
- Condition
- Essential Hypertension
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001134
- Subject identifier
- D000075222
And 6 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000278
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000538
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001074
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001645
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002756
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003896
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003913
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004214
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004234
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007148
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008008
- Condition identifier
- EFO_0009878
- Highest recorded phase
- 1
- Condition identifier
- EFO_0020925
- Condition identifier
- EFO_1001145
- Condition identifier
- EFO_1001461
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001996
- Condition identifier
- HP_0000822
- Highest recorded phase
- 4
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
And 51 more, listed on the interactive page.
- Event
- acute kidney injury
- Reports
- 983
- Reporting signal score
- 585.958
- Event
- blood pressure inadequately controlled
- Reports
- 249
- Reporting signal score
- 595.679
- Event
- blood pressure increased
- Reports
- 710
- Reporting signal score
- 483.768
- Event
- bradycardia
- Reports
- 747
- Reporting signal score
- 652.812
- Event
- cardiogenic shock
- Reports
- 388
- Reporting signal score
- 778.836
- Event
- distributive shock
- Reports
- 159
- Reporting signal score
- 509.934
- Event
- drug interaction
- Reports
- 1,026
- Reporting signal score
- 452.394
- Event
- fall
- Reports
- 1,106
- Reporting signal score
- 326.922
- Event
- gingival hyperplasia
- Reports
- 137
- Reporting signal score
- 449.058
- Event
- gingival hypertrophy
- Reports
- 252
- Reporting signal score
- 841.924
- Event
- hypertension
- Reports
- 957
- Reporting signal score
- 420.637
- Event
- hypertensive crisis
- Reports
- 281
- Reporting signal score
- 410.48
- Event
- hypokalaemia
- Reports
- 449
- Reporting signal score
- 341.679
- Event
- hypotension
- Reports
- 2,830
- Reporting signal score
- 3,393.78
- Event
- joint swelling
- Reports
- 618
- Reporting signal score
- 382.947
- Event
- metabolic acidosis
- Reports
- 583
- Reporting signal score
- 827.508
- Event
- non-cardiogenic pulmonary oedema
- Reports
- 190
- Reporting signal score
- 648.007
- Event
- oedema peripheral
- Reports
- 1,115
- Reporting signal score
- 912.18
- Event
- orthostatic hypotension
- Reports
- 518
- Reporting signal score
- 803.46
- Event
- shock
- Reports
- 765
- Reporting signal score
- 1,591.42
- Event
- suicide attempt
- Reports
- 797
- Reporting signal score
- 803.314
- Event
- syncope
- Reports
- 664
- Reporting signal score
- 375.921
- Event
- toxicity to various agents
- Reports
- 1,264
- Reporting signal score
- 1,199.53
- Event
- vasoplegia syndrome
- Reports
- 182
- Reporting signal score
- 560.329
- NCT00000522
- NCT00000542
- NCT00000620
- NCT00039975
- NCT00170950
- NCT00170963
- NCT00170976
- NCT00171002
- NCT00171366
- NCT00171535
- NCT00185133
- NCT00281580
- NCT00289406
- NCT00327145
- NCT00327587
- NCT00350168
- NCT00353912
- NCT00360178
- NCT00367939
- NCT00368277
- NCT00392262
- NCT00402103
- NCT00409643
- NCT00409760
- NCT00409851
And 162 more, listed on the interactive page.
- Dose
- 2.5-10mg
- How often
- Once daily
- Initial dose in adults: 5mg; may be reduced to 2.5mg in fragile, elderly, or hepatic insufficiency patients
- Pediatric dose: 2.5mg to 5mg; doses above 5mg not studied in pediatric
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 2
- Polar surface area
- 99.88
- Calculated partition coefficient (ALogP)
- 2.27
- Calculated partition coefficient (XLogP)
- 3
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 8
- Heavy atoms
- 28
- Molecular formula
- C20H25ClN2O5
- Monoisotopic mass
- 408.1451996
- Natural product
- Yes
- 23155-844
- 23155-845
- 23155-846
- 23155-847
- 46287-035
- 46287-037
- 51407-771
- 51407-772
- 51407-773
- 51407-774
- 64380-214
- 64380-215
- 64380-216
- 64380-217
- Recorded assays
- 1,979
- Active assays
- 87
- Confirmatory
- Other
- Screening
- Summary
- Antihypertensive Agents
- Calcium Channel Blockers
- Vasodilator Agents
These details could not be displayed.
Related records
Trials (477)
- 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
- 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
- 8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension
- A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
- A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
- A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
- A Bioequivalence Study of Valsartan / Amlodipine From Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)
- A Clinical Study Comparing Ankle Swelling Caused by Two Different Blood Pressure Medications, Levamlodipine and Amlodipine, in Post-menopausal Women With Mild High Blood Pressure.
- A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
- A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
- A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
- A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)
- A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
- A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
- A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
- A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study
- A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
- A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
- A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
- A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
Approved for (1)
In development for (31)
- Abdominal aortic aneurysm Phase 2
- Aortic valve insufficiency Phase 2
- Atherosclerosis Phase 3
- Beta-thalassemia major Phase 2
- Breast cancer Phase 1
- Congestive heart failure Phase 3
- Coronary artery disorder Phase 3
- Depressive disorder Phase 3
- Diabetes mellitus Phase 3
- Endometrial cancer Phase 2
- Erectile dysfunction Phase 1
- Essential hypertension Phase 3
- Focal dystonia Phase 2
- Heart disorder Phase 2
- Heart failure Phase 3
- HIV infectious disease Phase 1
- Hyperlipidemia Phase 1
- Hypertensive disorder Phase 3
- Hypertrophic cardiomyopathy Phase 2
- Kidney disorder Phase 1
Other linked conditions (2)
- Essential hypertension, genetic
- Morbid obesity