Diovan, Copalia(valsartan)
Byvalson, Copalia, Dafiro, Diovan, Entresto, Exforge, Neparvis, Valturna (valsartan) is a small molecule pharmaceutical. Valsartan was first approved as Diovan on 1996-12-23. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. It has been approved in Europe to treat heart failure and hypertension. The pharmaceutical is active against type-1 angiotensin II receptor. In addition, it is known to target voltage-dependent L-type calcium channel subunit alpha-1D, voltage-dependent L-type calcium channel subunit alpha-1C, and palmitoleoyl-protein carboxylesterase NOTUM.
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Novartis Pharmaceuticals
Searched
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Diovan (generic drugs available since 2012-09-21, discontinued: Prexxartan)
CombinationsDiovan, Entresto, Exforge (generic drugs available since 2012-09-21, discontinued: Byvalson, Valturna)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aliskiren hemifumarate
+
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VALTURNA | Novartis | N-022217 DISCN | 2009-09-16 | 2 products |
Hide discontinued
Amlodipine besylate
+
Hydrochlorothiazide
+
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EXFORGE HCT | Novartis | N-022314 RX | 2009-04-30 | 5 products, RLD, RS |
Amlodipine besylate
+
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EXFORGE | Novartis | N-021990 RX | 2007-06-20 | 4 products, RLD, RS |
Hydrochlorothiazide
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Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DIOVAN HCT | Novartis | N-020818 RX | 1998-03-06 | 5 products, RLD |
Nebivolol hydrochloride
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Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BYVALSON | AbbVie | N-206302 DISCN | 2016-06-03 | 1 products, RLD |
Hide discontinued
Sacubitril
+
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ENTRESTO | Novartis | N-207620 RX | 2015-07-07 | 3 products, RLD, RS |
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DIOVAN | Novartis | N-021283 RX | 2001-07-18 | 4 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlodipine and valsartan | ANDA | 2023-05-20 |
| diovan | New Drug Application | 2022-03-09 |
| entresto | New Drug Application | 2021-07-12 |
| exforge hct | New Drug Application | 2022-03-09 |
| prexxartan | New Drug Application | 2018-01-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diabetic nephropathies | EFO_0000401 | D003928 | — |
| heart failure | EFO_0003144 | D006333 | I50 |
| hypertension | EFO_0000537 | D006973 | I10 |
| left ventricular dysfunction | — | D018487 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VALSARTAN, DIOVAN, NOVARTIS | |||
| 2024-04-19 | NPP | ||
SACUBITRIL / VALSARTAN, ENTRESTO, NOVARTIS PHARMS CORP | |||
| 2024-02-16 | M-82 | ||
| 2023-04-01 | PED | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sacubitril / Valsartan, Entresto, Novartis Pharms Corp | |||
| 11058667 | 2036-05-09 | U-3170 | |
| 9517226 | 2033-08-22 | U-3084 | |
| 9937143 | 2033-08-22 | U-3084 | |
| 11135192 | 2033-08-22 | U-3084 | |
| 8877938 | 2027-05-27 | DS, DP | |
| 9388134 | 2026-11-08 | U-1723 | |
| 8101659 | 2025-01-15 | DP | |
| 7468390 | 2023-11-27 | DP | |
| 8404744 | 2023-01-14 | DP | |
| 8796331 | 2023-01-14 | U-1723 | |
| Nebivolol Hydrochloride / Valsartan, Byvalson, Abbvie | |||
| 7838552 | 2027-10-04 | U-185 | |
| 7803838 | 2026-08-29 | DP | |
| Aliskiren Hemifumarate / Valsartan, Valturna, Novartis | |||
| 8168616 | 2026-07-03 | DP | |
| Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Exforge Hct, Novartis | |||
| 8101599 | 2023-05-16 | DP | |
| 8475839 | 2023-05-16 | DP | |
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09C: Angiotensin ii receptor blockers (arbs), plain
— C09CA: Angiotensin ii receptor blockers (arbs), plain
— C09CA03: Valsartan
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA03: Valsartan and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB01: Valsartan and amlodipine
— C09DB08: Valsartan and lercanidipine
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX01: Valsartan, amlodipine and hydrochlorothiazide
— C09DX02: Valsartan and aliskiren
— C09DX04: Valsartan and sacubitril
— C09DX05: Valsartan and nebivolol
— C10: Lipid modifying agents
— C10B: Lipid modifying agents, combinations
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX10: Rosuvastatin and valsartan
HCPCS
No data
Clinical
Clinical Trials
414 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 10 | 12 | 66 | 81 | 7 | 175 |
| Heart failure | D006333 | EFO_0003144 | I50 | 3 | 12 | 15 | 35 | 23 | 85 |
| Healthy volunteers/patients | — | 18 | 1 | — | 1 | 3 | 23 | ||
| Essential hypertension | D000075222 | I10 | — | 6 | 10 | 4 | 1 | 20 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 1 | 2 | 10 | 1 | 17 |
| Chronic renal insufficiency | D051436 | N18 | 2 | 1 | 2 | 4 | 1 | 9 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 2 | — | 5 | — | 7 | |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | 2 | 3 | 6 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 1 | 3 | 1 | 6 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | 1 | 1 | 3 | — | 6 |
Show 46 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 5 | — | 3 | — | 1 | 9 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | 4 | 1 | — | — | 4 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | 3 | — | — | 3 | |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | 1 | 2 | |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
| Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | 1 | 1 | — | — | 1 |
| Transcatheter aortic valve replacement | D065467 | — | 1 | 1 | — | — | 1 | ||
| Heart valve prosthesis implantation | D019918 | — | 1 | 1 | — | — | 1 | ||
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | 1 | |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial remodeling | D064752 | — | 1 | — | — | 1 | 2 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | 1 | 1 | — | — | — | 2 | ||
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | 1 | — | — | — | 1 | ||
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | 1 | — | — | — | 1 |
| Metabolism | D008660 | GO_0008152 | — | 1 | — | — | — | 1 | |
| Energy metabolism | D004734 | — | 1 | — | — | — | 1 | ||
| Acute coronary syndrome | D054058 | EFO_0005672 | — | 1 | — | — | — | 1 | |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | — | — | — | — | 1 |
| Magnetic resonance imaging | D008279 | 1 | — | — | — | — | 1 | ||
| Oral administration | D000284 | 1 | — | — | — | — | 1 | ||
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Frailty | D000073496 | R53.1 | — | — | — | — | 1 | 1 | |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 1 | 1 | ||
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Hiv | D006678 | O98.7 | — | — | — | — | 1 | 1 | |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Orthostatic hypotension | D007024 | I95.1 | — | — | — | — | 1 | 1 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Microvascular angina | D017566 | — | — | — | — | 1 | 1 | ||
| Cardio-renal syndrome | D059347 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | VALSARTAN |
| INN | valsartan |
| Description | Valsartan is a monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity. It has a role as an antihypertensive agent, an angiotensin receptor antagonist, a xenobiotic and an environmental contaminant. It is a biphenylyltetrazole, a monocarboxylic acid amide and a monocarboxylic acid. |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1)[C@H](C(=O)O)C(C)C |
Identifiers
| PDB | 7BM1 |
| CAS-ID | 137862-53-4 |
| RxCUI | 69749 |
| ChEMBL ID | CHEMBL1069 |
| ChEBI ID | 9927 |
| PubChem CID | 60846 |
| DrugBank | DB00177 |
| UNII ID | 80M03YXJ7I (ChemIDplus, GSRS) |
Target
Agency Approved
AGTR1
AGTR1
Organism
Homo sapiens
Gene name
AGTR1
Gene synonyms
AGTR1A, AGTR1B, AT2R1, AT2R1B
NCBI Gene ID
Protein name
type-1 angiotensin II receptor
Protein synonyms
Angiotensin II type-1 receptor, AT1 receptor, AT1AR, AT1BR, type-1B angiotensin II receptor
Uniprot ID
Mouse ortholog
Agtr1b (11608)
type-1 angiotensin II receptor B (P29755)
Alternate
CACNA1D
CACNA1D
CACNA1C
CACNA1C
NOTUM
NOTUM
Organism
Homo sapiens
Gene name
CACNA1D
Gene synonyms
CACH3, CACN4, CACNL1A2, CCHL1A2
NCBI Gene ID
Protein name
voltage-dependent L-type calcium channel subunit alpha-1D
Protein synonyms
calcium channel, L type, alpha-1 polypeptide, Calcium channel, L type, alpha-1 polypeptide, isoform 2, calcium channel, neuroendocrine/brain-type, alpha 1 subunit, calcium channel, voltage-dependent, L type, alpha 1D subunit, voltage-gated calcium channel alpha 1 subunit, voltage-gated calcium channel alpha subunit Cav1.3, Voltage-gated calcium channel subunit alpha Cav1.3
Uniprot ID
Mouse ortholog
Cacna1d (12289)
voltage-dependent L-type calcium channel subunit alpha-1D (Q99246)
Variants
Clinical Variant
No data
Financial
Diovan - Novartis
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Exforge - Novartis
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Entresto - Novartis
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,260 documents
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Safety
Black-box Warning
Black-box warning for: Amlodipine and valsartan, Diovan, Entresto, Exforge hct, Prexxartan
Adverse Events
Top Adverse Reactions
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33 adverse events reported
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