Diovan, Copalia(valsartan)
/ Valsartan, Amlodipine / Valsartan, Amlodipine Besylate / Hydrochlorothiazide / Valsartan, Amlodipine Besylate / Valsartan, Copalia, Dafiro, Diovan, Entresto, Exforge, Hydrochlorothiazide / Valsartan, Neparvis, Valsartan, Valturna, Vyduo (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 and voltage-dependent L-type calcium channel subunit alpha-1C.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Diovan, Valsartan (discontinued: Diovan, Prexxartan, Valsartan)
CombinationsAmlodipine besylate valsartan, Amlodipine besylate, valsartan hydrochlorothiazide, Diovan, Entresto, Exforge, Sacubitril valsartan, Valsartan hydrochlorothiazide, Vyduo (discontinued: Amlodipine besylate valsartan, Amlodipine besylate, valsartan hydrochlorothiazide, Byvalson, Valsartan hydrochlorothiazide, Valturna)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Valsartan
Valsartan
Sacubitril
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Valsartan
Amlodipine besylate
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Valsartan
Amlodipine besylate
+
Hydrochlorothiazide
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Valsartan
Aliskiren hemifumarate
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Valsartan
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlodipine and valsartan | ANDA | 2026-04-16 |
| amlodipine besylate and valsartan | ANDA | 2014-12-16 |
| amlodipine, valsartan and hydrochlorothiazide | ANDA | 2024-05-17 |
| amlodipine, valsartan, hydrochlorothiazide | ANDA | 2025-06-02 |
| amlodipine,valsartan and hydrochlorothiazide | ANDA | 2025-01-09 |
| clopidogrel | ANDA | 2021-10-12 |
| diovan | New Drug Application | 2026-08-11 |
| diovan hct | New Drug Application | 2026-02-13 |
| entresto | New Drug Application | 2026-07-06 |
| exforge | New Drug Application | 2026-02-17 |
Show 6 more
Indications
FDA
EMA
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
568 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 | 4 | 13 | 60 | 47 | 3 | 126 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 6 | 12 | 15 | 15 | 49 |
| Essential hypertension | D000075222 | — | I10 | — | 4 | 10 | 2 | 1 | 16 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | 4 | 1 | 6 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | — | 1 | 4 | — | 6 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | 3 | — | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 2 | 2 | — | 4 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 4 | — | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 3 | — | 4 |
| Systolic murmurs | D054160 | — | R01.1 | — | — | 1 | 1 | 1 | 3 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 1 | — | — | 3 |
| Hypercholesterolemia | D006937 | — | — | — | — | 3 | — | — | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 1 | — | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | 1 | — | — | 2 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 2 | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | 1 | — | — | 2 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 1 | — | — | 1 |
| Non-st elevated myocardial infarction | D000072658 | — | — | — | — | 1 | — | — | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | 1 | — | — | — | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | — | — | — | 1 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | — | — | 1 | 1 |
| Microvascular angina | D017566 | — | — | — | — | — | — | 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 | — |
| CAS-ID | 137862-53-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1069 |
| ChEBI ID | 9927 |
| PubChem CID | 60846 |
| DrugBank | DB00177 |
| UNII ID | 80M03YXJ7I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
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
No data
Financial
Revenue by drug
$
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Estimated US medical usage
Valsartan
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Aliskiren
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Valsartan
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Amlodipine
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Hydrochlorothiazide
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Valsartan
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Amlodipine
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Valsartan
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Hydrochlorothiazide
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Valsartan
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Sacubitril
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Valsartan
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Amlodipine and valsartan, Amlodipine besylate and valsartan, Amlodipine, valsartan and hydrochlorothiazide, Amlodipine, valsartan, hydrochlorothiazide, Amlodipine,valsartan and hydrochlorothiazide, Clopidogrel, Diovan, Diovan hct, Entresto, Exforge, Exforge hct, Prexxartan, Sacubitril and valsartan, Valsartan, Valsartan and hydrochlorothiazide, Valsartan/htcz
Adverse Events
Top Adverse Reactions
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178,647 adverse events reported
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