Valsartan - PharmaKB

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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Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
cardiovascular diseases	D002318
endocrine system diseases	D004700

Trade Name

FDA

EMA

Diovan, Valsartan (discontinued: Diovan, Prexxartan, Valsartan)

Combinations

Amlodipine 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)

Abbreviated New Drug Application (ANDA)

Hydrochlorothiazide

Valsartan

Tradename	Company	Number	Date	Products
DIOVAN HCT	Novartis	N-020818 RX	1998-03-06	5 products, RLD

Valsartan

Tradename	Company	Number	Date	Products
DIOVAN	Novartis	N-021283 RX	2001-07-18	4 products, RLD, RS

Show 2 discontinued

Sacubitril

Valsartan

Tradename	Company	Number	Date	Products
ENTRESTO SPRINKLE	Novartis	N-218591 RX	2024-04-12	2 products, RLD, RS
ENTRESTO	Novartis	N-207620 RX	2015-07-07	3 products, RLD, RS

Amlodipine besylate

Valsartan

Tradename	Company	Number	Date	Products
EXFORGE	Novartis	N-021990 RX	2007-06-20	4 products, RLD, RS

Amlodipine besylate

Hydrochlorothiazide

Valsartan

Tradename	Company	Number	Date	Products
EXFORGE HCT	Novartis	N-022314 RX	2009-04-30	5 products, RLD, RS

Aliskiren hemifumarate

Valsartan

Tradename	Company	Number	Date	Products
VALTURNA	Novartis	N-022217 DISCN	2009-09-16	2 products

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Nebivolol hydrochloride

Valsartan

Tradename	Company	Number	Date	Products
BYVALSON	AbbVie	N-206302 DISCN	2016-06-03	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
amlodipine and valsartan	ANDA	2025-02-24
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	2024-12-20
diovan hct	New Drug Application	2024-12-20
entresto	New Drug Application	2025-06-26
exforge	New Drug Application	2025-04-02

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	EFO_0003144	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
hypertension	EFO_0000537	D006973	I10
left ventricular dysfunction	—	D018487	—
coronary artery disease	—	D003324	I25.1
variant angina pectoris	—	D000788	I20.1
nephrotic syndrome	EFO_0004255	D009404	N04
edema	—	D004487	R60.9
malignant hypertension	EFO_1001031	D006974	—

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

533 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	22	93	100	17	245
Heart failure	D006333	EFO_0003144	I50	6	21	20	49	41	132
Essential hypertension	D000075222	—	I10	—	9	24	13	3	48
Healthy volunteers/patients	—	—	—	25	1	—	1	3	30
Kidney diseases	D007674	EFO_0003086	N08	3	4	3	17	4	29
Diabetes mellitus	D003920	EFO_0000400	E08-E13	1	2	5	17	2	26
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	4	2	3	13	2	23
Chronic renal insufficiency	D051436	—	N18	3	3	3	7	2	16
Cardiovascular diseases	D002318	EFO_0000319	I98	—	3	6	5	1	14
Myocardial infarction	D009203	EFO_0000612	I21	—	1	5	4	2	12

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperlipidemias	D006949	EFO_0003774	E78.5	7	—	3	—	1	11
Atherosclerosis	D050197	EFO_0003914	I25.1	—	1	2	—	2	5
Hypertrophic cardiomyopathy	D002312	EFO_0000538	I42.1	—	4	1	—	—	4
Hiv infections	D015658	EFO_0000764	B20	—	2	1	—	1	4
Inferior wall myocardial infarction	D056989	EFO_1000983	—	—	—	2	—	1	3
Hyperlipoproteinemias	D006951	—	—	—	—	3	—	—	3
St elevation myocardial infarction	D000072657	—	—	—	—	3	—	—	3
Pulmonary hypertension	D006976	EFO_0001361	I27.20	—	1	1	—	—	2
Pathologic constriction	D003251	—	—	—	1	1	—	1	2
Non-st elevated myocardial infarction	D000072658	—	—	—	—	2	—	—	2

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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
Nephrosis	D009401	—	—	1	1	—	—	—	2
Myositis	D009220	EFO_0000783	G72.49	—	1	—	—	—	1
Metabolic diseases	D008659	EFO_0000589	E88.9	—	1	—	—	—	1
Metabolism	D008660	GO_0008152	—	—	1	—	—	—	1
Energy metabolism	D004734	—	—	—	1	—	—	—	1
Arthritis	D001168	EFO_0005856	M05-M14	1	1	—	—	—	1

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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
Purpura	D011693	HP_0000979	D69.2	1	—	—	—	—	1
Magnetic resonance imaging	D008279	—	—	1	—	—	—	—	1
Oral administration	D000284	—	—	1	—	—	—	—	1
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	1	—	—	—	—	1
Obstructive lung diseases	D008173	—	—	1	—	—	—	—	1
Thyroid neoplasms	D013964	EFO_0003841	—	1	—	—	—	—	1
Papillary thyroid cancer	D000077273	—	—	1	—	—	—	—	1
Thyroid diseases	D013959	—	E00-E07	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	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
Orthostatic hypotension	D007024	—	I95.1	—	—	—	—	1	1
Malnutrition	D044342	EFO_0008572	E40-E46	—	—	—	—	1	1
Angina pectoris	D000787	EFO_0003913	I20	—	—	—	—	1	1
Microvascular angina	D017566	—	—	—	—	—	—	1	1
Transient ischemic attack	D002546	EFO_0003764	G45.9	—	—	—	—	1	1

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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

CACNA1C

NOTUM

Organism

Homo sapiens

Gene name

CACNA1D

Gene synonyms

CACH3, CACN4, CACNL1A2, CCHL1A2

NCBI Gene ID

776

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

Q01668

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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Entresto – Novartis

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Diovan – Novartis

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Exforge – Novartis

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Estimated US medical usage

Valsartan

Aliskiren

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Valsartan

Amlodipine

Hydrochlorothiazide

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Valsartan

Amlodipine

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Valsartan

Hydrochlorothiazide

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Valsartan

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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175,724 adverse events reported

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