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Tekturna, Rasilez(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
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Tekturna (generic drugs available since 2019-03-22)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aliskiren hemifumarate
Tradename
Company
Number
Date
Products
TEKTURNANoden PharmaN-021985 RX2007-03-05
2 products, RLD, RS
Show 1 discontinued
Aliskiren hemifumarate
+
Amlodipine besylate
Tradename
Company
Number
Date
Products
TEKAMLONovartisN-022545 DISCN2010-08-26
4 products
Hide discontinued
Aliskiren hemifumarate
+
Amlodipine besylate
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
AMTURNIDENovartisN-200045 DISCN2010-12-21
5 products
Hide discontinued
Aliskiren hemifumarate
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
TEKTURNA HCTNoden PharmaN-022107 DISCN2008-01-18
4 products, RLD
Hide discontinued
Aliskiren hemifumarate
+
Valsartan
Tradename
Company
Number
Date
Products
VALTURNANovartisN-022217 DISCN2009-09-16
2 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aliskirenNDA authorized generic2023-05-25
tekturnaNew Drug Application2023-05-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypertensionEFO_0000537D006973I10
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
153 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10593836390
Type 2 diabetes mellitusD003924EFO_0001360E113315110
Heart failureD006333EFO_0003144I50—333110
Essential hypertensionD000075222I10——43—7
Chronic renal insufficiencyD051436N18———5—5
Diabetes mellitusD003920EFO_0000400E08-E131——315
ProteinuriaD011507HP_0000093R80———4—4
Iga glomerulonephritisD005922EFO_0004194——13—4
Metabolic syndromeD024821EFO_0000195E88.8111—2—4
Left ventricular hypertrophyD017379EFO_0003896——12—3
Show 13 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AtherosclerosisD050197EFO_0003914I25.1—11—12
OverweightD050177E66.3——1——1
Marfan syndromeD008382Orphanet_558Q87.4——1——1
Cardiovascular diseasesD002318EFO_0000319I98——1——1
Myocardial infarctionD009203EFO_0000612I21——1——1
Atrial fibrillationD001281EFO_0000275I48.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614—1——12
Acute coronary syndromeD054058EFO_0005672—1———1
Myocardial ischemiaD017202EFO_1001375I20-I25—1———1
Macular edemaD008269—1———1
GlomerulonephritisD005921N05—1———1
Membranoproliferative glomerulonephritisD015432—1———1
Renal insufficiencyD051437HP_0000083N19—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Glucose metabolism disordersD0448821————1
Endocrine system diseasesD004700EFO_0001379E34.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Abdominal aortic aneurysmD017544EFO_0004214————11
Diastolic heart failureD054144EFO_1000899I50.30————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)
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
PDB2V0Z
CAS-ID173334-57-1
RxCUI325646
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,161 documents
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Safety
Black-box Warning
Black-box warning for: Aliskiren, Tekturna
Adverse Events
Top Adverse Reactions
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4,256 adverse events reported
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