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Drug ReportsAliskiren
Tekturna, Enviage(aliskiren)
Aliskiren, Amturnide, Rasilamlo, Rasilez, Rasitrio, Riprazo, Sprimeo, Tekamlo, Tekturna, Valturna (aliskiren) is a small molecule pharmaceutical. Aliskiren was first approved as Tekturna on 2007-03-05. It is used to treat hypertension in the USA. It has been approved in Europe to treat hypertension. The pharmaceutical is active against renin.
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Commercial
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Drug
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5D
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Aliskiren, Tekturna (discontinued: Tekturna)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aliskiren hemifumarate
+
Amlodipine besylate
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
AMTURNIDENovartisN-200045 DISCN2010-12-21
5 products
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Aliskiren hemifumarate
+
Amlodipine besylate
Tradename
Company
Number
Date
Products
TEKAMLONovartisN-022545 DISCN2010-08-26
4 products
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Aliskiren hemifumarate
+
Valsartan
Tradename
Company
Number
Date
Products
VALTURNANovartisN-022217 DISCN2009-09-16
2 products
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Aliskiren hemifumarate
Tradename
Company
Number
Date
Products
TEKTURNANoden PharmaN-021985 RX2007-03-05
2 products, RLD, RS
Show 1 discontinued
Aliskiren hemifumarate
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
TEKTURNA HCTNoden PharmaN-022107 DISCN2008-01-18
4 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
aliskirenNDA authorized generic2023-05-25
tekturnaNew Drug Application2024-03-07
tekturna hctNew Drug Application2022-11-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
hypertensionEFO_0000537D006973I10
nephrotic syndromeEFO_0004255D009404N04
coronary artery disease—D003324I25.1
edema—D004487R60.9
variant angina pectoris—D000788I20.1
diabetic nephropathiesEFO_0000401D003928—
left ventricular dysfunction—D018487—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Aliskiren Hemifumarate / Amlodipine Besylate, Tekamlo, Novartis
86139492029-12-21DP
Aliskiren Hemifumarate / Hydrochlorothiazide, Tekturna Hct, Noden Pharma
86181722028-07-13DP
Aliskiren Hemifumarate / Valsartan, Valturna, Novartis
81686162026-07-03DP
Aliskiren Hemifumarate, Tekturna, Noden Pharma
86175952026-02-19DP
Aliskiren Hemifumarate / Amlodipine Besylate / Hydrochlorothiazide, Amturnide, Novartis
81832952023-05-16DP
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX02: Valsartan and aliskiren
— C09X: Other agents acting on the renin-angiotensin system in atc
— C09XA: Renin-inhibitors
— C09XA02: Aliskiren
— C09XA52: Aliskiren and hydrochlorothiazide
— C09XA53: Aliskiren and amlodipine
— C09XA54: Aliskiren, amlodipine and hydrochlorothiazide
HCPCS
No data
Clinical
Clinical Trials
160 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAliskiren
INNaliskiren
Description
Aliskiren is a monomethoxybenzene compound having a 3-methoxypropoxy group at the 2-position and a multi-substituted branched alkyl substituent at the 4-position. It has a role as an antihypertensive agent. It is a monomethoxybenzene and a monocarboxylic acid amide.
Classification
Small molecule
Drug classrenin inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Identifiers
PDB—
CAS-ID173334-57-1
RxCUI—
ChEMBL IDCHEMBL1639
ChEBI ID601027
PubChem CID5493444
DrugBankDB01258
UNII ID502FWN4Q32 (ChemIDplus, GSRS)
Target
Agency Approved
REN
REN
Organism
Homo sapiens
Gene name
REN
Gene synonyms
NCBI Gene ID
5972
Protein name
renin
Protein synonyms
angiotensin-forming enzyme, Angiotensinogenase, renin precursor, renal
Uniprot ID
Q6T5C2
Mouse ortholog
Ren1 (19701)
renin-1 (Q62154)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Aliskiren
Total medical expenditures per year (USD, in millions)
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Aliskiren
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Amlodipine
Total medical expenditures per year (USD, in millions)
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Aliskiren
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Aliskiren
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Valsartan
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,647 documents
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Safety
Black-box Warning
Black-box warning for: Aliskiren, Tekturna, Tekturna hct
Adverse Events
Top Adverse Reactions
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8,902 adverse events reported
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