Valsartan
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Valsartan
- Molecular weight
- 435.53
- Structure (SMILES)
- CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1)[C@H](C(=O)O)C(C)C
- diovan
- Diovan
- prexxartan
- Prexxartan
- valsartan
- Valsartan
- valsartan component of agsav301
- Valsartan component of agsav301
- valsartan component of byvalson
- Valsartan component of byvalson
- valsartan component of copalia
- Valsartan component of copalia
- valsartan component of copalia hct
- Valsartan component of copalia-hct
- valsartan component of dafiro
- Valsartan component of dafiro
- valsartan component of dafiro hct
- Valsartan component of dafiro-hct
- valsartan component of diovan hct
- Valsartan component of diovan hct
- valsartan component of entresto
- Valsartan component of entresto
- valsartan component of exforge
- Valsartan component of exforge
- valsartan component of exforge hct
And 7 more, listed on the interactive page.
- agsav301 component valsartan
- AGSAV301 component valsartan
- ahu377 100 mg valsartan 320 mg
- cgp 48933
- CGP 48933
- CGP-48933
- cgp48933
- CGP48933
- cilnidipine valsartan
- copalia component valsartan
- Copalia component valsartan
- copalia hct component valsartan
- COPALIA-HCT COMPONENT VALSARTAN
- dafiro component valsartan
- DAFIRO COMPONENT VALSARTAN
- dafiro hct component valsartan
- DAFIRO-HCT COMPONENT VALSARTAN
- Diovan
- Diovan (Valsartan)
- diovan hct component valsartan
- DIOVAN HCT COMPONENT VALSARTAN
- Diovan® (valsartan)
- entresto component valsartan
- ENTRESTO COMPONENT VALSARTAN
- exforge component valsartan
And 66 more, listed on the interactive page.
- ATC classification codes
- C09CA03
Sources for recorded values
- CAS registry numbers
- 137862-53-4
- ChEMBL ID
- CHEMBL1069
- InChIKey
- ACWBQPMHZXGDFX-QFIPXVFZSA-N
- PubChem compound IDs
- 60846
- RxNorm IDs (RxCUI)
- 69749
- FDA ingredient codes (UNII)
- 80M03YXJ7I
- Applicant
- NOVARTIS
- Approval date
- 6 Mar 1998
- Application number
- NDA020818
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- valsartan
- Type
- Synthetic organic
- Drug name stem
- -sartan
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- AT1 receptor
- Gene symbol
- AGTR1
- Protein identifier
- P30556
- Median affinity
- 8.61
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Action type
- Antagonist
- Target
- Type-1 angiotensin II receptor
- Protein identifier
- P30556
Open Targets mechanisms
- Mechanism
- Type-1 angiotensin II receptor antagonist
- Action type
- Antagonist
- Target
- Type-1 angiotensin II receptor
DrugCentral mechanisms
- Action type
- Antagonist
- Gene symbol
- AGTR1
- Protein identifier
- P30556
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Ventricular Dysfunction, Left
- Highest recorded phase
- 4
- Subject identifier
- D018487
- Condition
- Metabolic Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000195
- Subject identifier
- D024821
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Hypertension
- Highest recorded phase
- 4
- 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
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Stroke
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Kidney Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Atherosclerosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Peripheral Arterial Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004265
- Subject identifier
- D058729
- Condition
- Chagas Cardiomyopathy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005529
- Subject identifier
- D002598
- Condition
- Acute Coronary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005672
- Subject identifier
- D054058
- Condition
- Aortic Valve Insufficiency
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007148
- Subject identifier
- D001022
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Non-ST Elevated Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008586
- Subject identifier
- D000072658
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
And 6 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000275
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000373
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000538
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0001074
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003896
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003913
- Condition identifier
- EFO_0003914
- Condition identifier
- EFO_0004265
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004352
- Condition identifier
- EFO_0005109
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005529
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005672
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007148
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008583
- Condition identifier
- EFO_0009909
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001207
- Condition identifier
- HP_0000093
- Highest recorded phase
- 2
And 58 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- acute kidney injury
- Reports
- 1,152
- Reporting signal score
- 600.948
- Event
- angioedema
- Reports
- 642
- Reporting signal score
- 456.802
- Event
- blood creatinine increased
- Reports
- 1,004
- Reporting signal score
- 1,005.62
- Event
- blood potassium increased
- Reports
- 469
- Reporting signal score
- 825.743
- Event
- blood pressure decreased
- Reports
- 847
- Reporting signal score
- 940.704
- Event
- blood pressure inadequately controlled
- Reports
- 272
- Reporting signal score
- 605.626
- Event
- blood pressure increased
- Reports
- 1,012
- Reporting signal score
- 764.862
- Event
- cardiac failure
- Reports
- 1,142
- Reporting signal score
- 1,453.84
- Event
- cardiac failure chronic
- Reports
- 189
- Reporting signal score
- 425.459
- Event
- cough
- Reports
- 1,390
- Reporting signal score
- 628.905
- Event
- dizziness
- Reports
- 2,480
- Reporting signal score
- 1,056.63
- Event
- dyspnoea
- Reports
- 2,468
- Reporting signal score
- 778.98
- Event
- ejection fraction decreased
- Reports
- 481
- Reporting signal score
- 728.883
- Event
- hyperkalaemia
- Reports
- 957
- Reporting signal score
- 1,325.13
- Event
- hypotension
- Reports
- 3,757
- Reporting signal score
- 4,587.49
- Event
- renal failure
- Reports
- 787
- Reporting signal score
- 462.559
- Event
- renal impairment
- Reports
- 751
- Reporting signal score
- 485.883
- Event
- wrong technique in product usage process
- Reports
- 862
- Reporting signal score
- 425.395
- NCT00000620
- NCT00034840
- NCT00130156
- NCT00140790
- NCT00154271
- NCT00168779
- NCT00170963
- NCT00170976
- NCT00170989
- NCT00171002
- NCT00171015
- NCT00171028
- NCT00171041
- NCT00171054
- NCT00171067
- NCT00171080
- NCT00171093
- NCT00171132
- NCT00171353
- NCT00171535
- NCT00171561
- NCT00171756
- NCT00171782
- NCT00240448
- NCT00241007
And 173 more, listed on the interactive page.
- Dose
- 80-160 mg / 1 mg/kg / 2 mg/kg / 40 mg / 20 mg
- Route
- Oral
- How often
- Once daily / twice daily
- Do not use in children less than 1 year of age
- May require dose adjustment when switching between suspension and tablets
- Use in pediatric patients aged 1 to 5 years and above who cannot swallow tablets
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 2
- Polar surface area
- 112.07
- Calculated partition coefficient (ALogP)
- 4.16
- Calculated partition coefficient (XLogP)
- 4.4
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 10
- Heavy atoms
- 32
- Molecular formula
- C24H29N5O3
- Monoisotopic mass
- 435.22703980
- Natural product
- Yes
- 0078-0314
- 0078-0315
- 0078-0358
- 0078-0359
- 0078-0360
- 0078-0383
- 0078-0423
- 0078-0471
- 0078-0472
- 0078-0488
- 0078-0489
- 0078-0490
- 0078-0491
- 0078-0559
- 0078-0560
- 0078-0561
- 0078-0562
- 0078-0563
- 0078-0659
- 0078-0696
- 0078-0777
- 0078-1231
- 0078-1238
- 0078-1245
- 0078-1252
And 388 more, listed on the interactive page.
- Recorded assays
- 4,001
- Active assays
- 19
- Confirmatory
- Other
- Screening
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
These details could not be displayed.
Related records
Trials (403)
- " Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
- 1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
- 24 Hour Ambulatory Cardiac Oxygen Consumption
- 8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 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 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
- A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome
- A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan
- A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
- A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
- A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
- A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
- A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
- 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 Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patients With Reduced Ejection Fraction Using Secondary US Electronic Health Records Data
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- A Morbidity-Mortality and Remodeling Study With Valsartan
- A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate 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 II Clinical Study of QR12000 Compound Tablets in Patients With Moderate to Severe Essential Hypertension
Approved for (8)
- Acute myocardial infarction
- Cardiovascular disorder
- Congestive heart failure
- Diabetes mellitus
- Heart failure
- Hypertensive disorder
- Myocardial infarction
- Stroke disorder
In development for (20)
- Acute coronary syndrome Phase 2
- Alport syndrome Phase 2
- Aortic valve insufficiency Phase 2
- Atherosclerosis Phase 3
- Atrial fibrillation Phase 3
- Chagas cardiomyopathy Phase 3
- Chronic kidney disease Phase 2
- Coronary artery disorder Phase 3
- COVID-19 Phase 3
- Diabetic kidney disease Phase 2
- Essential hypertension Phase 3
- Hypertrophic cardiomyopathy Phase 2
- Inherited lipid metabolism disorder Phase 3
- Kidney disorder Phase 3
- Metabolic syndrome X Phase 3
- Peripheral arterial disease Phase 2
- Pulmonary hypertension Phase 3
- Severe acute respiratory syndrome Phase 3
- ST-elevation myocardial infarction Phase 3
- Type 2 diabetes mellitus Phase 3
Other linked conditions (2)
- Morbid obesity
- Systolic heart failure
Targets (1)
- AGTR1 Type-1 angiotensin II receptor antagonist