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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
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
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Amlodipine besylate
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Hydrochlorothiazide
Aliskiren hemifumarate
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Amlodipine besylate
Aliskiren hemifumarate
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Valsartan
Aliskiren hemifumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEKTURNA | Noden Pharma | N-021985 RX | 2007-03-05 | 2 products, RLD, RS |
Show 1 discontinued
Aliskiren hemifumarate
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Hydrochlorothiazide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEKTURNA HCT | Noden Pharma | N-022107 DISCN | 2008-01-18 | 4 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aliskiren | NDA authorized generic | 2023-05-25 |
| tekturna | New Drug Application | 2024-03-07 |
| tekturna hct | New Drug Application | 2022-11-16 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Aliskiren Hemifumarate / Amlodipine Besylate, Tekamlo, Novartis | |||
| 8613949 | 2029-12-21 | DP | |
| Aliskiren Hemifumarate / Hydrochlorothiazide, Tekturna Hct, Noden Pharma | |||
| 8618172 | 2028-07-13 | DP | |
| Aliskiren Hemifumarate / Valsartan, Valturna, Novartis | |||
| 8168616 | 2026-07-03 | DP | |
| Aliskiren Hemifumarate, Tekturna, Noden Pharma | |||
| 8617595 | 2026-02-19 | DP | |
| Aliskiren Hemifumarate / Amlodipine Besylate / Hydrochlorothiazide, Amturnide, Novartis | |||
| 8183295 | 2023-05-16 | DP | |
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
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Clinical
Clinical Trials
159 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 | 6 | 10 | 45 | 41 | 6 | 107 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 2 | 2 | 3 | 10 | 4 | 20 |
| Essential hypertension | D000075222 | — | I10 | 1 | 1 | 12 | 4 | — | 18 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 3 | 4 | 1 | 10 | 1 | 17 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 3 | 1 | 6 | 1 | 11 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 3 | 3 | 3 | 2 | 11 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 6 | — | 6 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 2 | 1 | — | 3 | — | 6 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | — | 4 | — | 5 |
| Syndrome | D013577 | — | — | 1 | 2 | 1 | 1 | — | 5 |
Show 21 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 3 | — | 1 | 4 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | — | — | 2 |
| Overweight | D050177 | — | E66.3 | — | — | 1 | — | — | 1 |
| Marfan syndrome | D008382 | Orphanet_558 | Q87.4 | — | — | 1 | — | — | 1 |
| Arachnodactyly | D054119 | — | — | — | — | 1 | — | — | 1 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | — | — | 1 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | 1 | — | — | — | 1 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | — | — | — | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | — | — | 1 |
| Macular edema | D008269 | — | — | — | 1 | — | — | — | 1 |
| Edema | D004487 | HP_0000969 | R60.9 | — | 1 | — | — | — | 1 |
| Membranoproliferative glomerulonephritis | D015432 | — | — | — | 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 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | — | — | — | 1 | 1 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | — | — | — | — | 1 | 1 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Aliskiren |
| INN | aliskiren |
| 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 class | renin 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
| PDB | — |
| CAS-ID | 173334-57-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1639 |
| ChEBI ID | 601027 |
| PubChem CID | 5493444 |
| DrugBank | DB01258 |
| UNII ID | 502FWN4Q32 (ChemIDplus, GSRS) |
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Aliskiren
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Aliskiren
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Amlodipine
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Aliskiren
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Hydrochlorothiazide
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Aliskiren
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Valsartan
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PubMed Central
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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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8,579 adverse events reported
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