Diovan, Copalia(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 (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
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Valsartan
Amlodipine besylate
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Hydrochlorothiazide
+
Valsartan
Amlodipine besylate
+
Valsartan
Hydrochlorothiazide
+
Valsartan
Nebivolol hydrochloride
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Valsartan
Sacubitril
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Valsartan
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlodipine and valsartan | ANDA | 2023-12-14 |
| amlodipine besylate and valsartan | ANDA | 2014-12-16 |
| amlodipine, valsartan and hydrochlorothiazide | ANDA | 2023-12-14 |
| amlodipine, valsartan, hydrochlorothiazide | ANDA | 2022-09-30 |
| clopidogrel | ANDA | 2021-08-23 |
| diovan | New Drug Application | 2023-07-11 |
| diovan hct | New Drug Application | 2023-07-11 |
| exforge | New Drug Application | 2023-07-13 |
| exforge hct | New Drug Application | 2023-07-13 |
| valsartan | ANDA | 2023-08-07 |
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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
513 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 | 16 | 13 | 75 | 89 | 12 | 203 |
| Heart failure | D006333 | HP_0001635 | I50 | 3 | 15 | 16 | 40 | 30 | 101 |
| Healthy volunteers/patients | — | — | — | 22 | 1 | — | 1 | 3 | 27 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | 2 | 3 | 11 | 2 | 21 |
| Essential hypertension | D000075222 | — | I10 | — | 6 | 10 | 5 | 1 | 21 |
| Chronic renal insufficiency | D051436 | — | N18 | 2 | 2 | 2 | 6 | 1 | 12 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 2 | 5 | 3 | 1 | 10 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 2 | — | 6 | 1 | 9 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | 3 | 4 | 8 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | 4 | 3 | 8 |
Show 56 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 7 | — | 3 | — | 1 | 11 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 4 | — | 1 | 5 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | 4 | 1 | — | — | 4 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 1 | — | 2 | 4 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | 2 | — | 1 | 3 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 2 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | — | 2 |
| Hyperkalemia | D006947 | HP_0002153 | E87.5 | — | — | 1 | — | 1 | 2 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial remodeling | D064752 | — | — | — | 1 | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | 1 | — | — | — | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | 1 | — | — | — | 2 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | 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 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 1 | 1 | — | — | — | 1 |
Show 9 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 |
| Papillary thyroid cancer | D000077273 | — | — | 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 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Microvascular angina | D017566 | — | — | — | — | — | — | 1 | 1 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | — | — | — | 1 | 1 |
Show 9 more
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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Additional graphs summarizing 17,327 documents
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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, Clopidogrel, Diovan, Diovan hct, Exforge, Exforge hct, Valsartan, Valsartan and hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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122,111 adverse events reported
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