Drugs / Aliskiren
last change Oct 2024 re-read 9 days ago

Aliskiren

Small molecule targets REN via inhibition

Developed for
hypertensive disorder · essential hypertension · type 2 diabetes mellitus · heart failure · diabetes mellitus · IgA glomerulonephritis · metabolic syndrome X · chronic kidney disease
+27 more · congestive heart failure · end stage renal failure · proteinuria · abdominal aortic aneurysm · abdominal obesity-metabolic syndrome · acute coronary syndrome · atherosclerosis · cardiovascular disorder · coronary artery disorder · coronary atherosclerosis · diabetic kidney disease · diabetic macular edema · heart disorder · hypertensive heart disease · idiopathic membranous glomerulonephritis · kidney disorder · Marfan syndrome · myocardial infarction · systolic heart failure · atrial fibrillation · chronic renal failure syndrome · complement 3 glomerulopathy · diastolic heart failure · focal segmental glomerulosclerosis · kidney failure · membranous glomerulonephritis · nephrosclerosis
Investigated by
Novartis · Novartis Pharmaceuticals · Taipei Veterans General Hospital, Taiwan · IRCCS San Raffaele · Medical University of Gdansk · National Taiwan University Hospital
+28 more · The University of Hong Kong · UMC Utrecht · University of Campania Luigi Vanvitelli · University of Pavia · American Heart Association · Amsterdam UMC, location VUmc · Assaf-Harofeh Medical Center · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · Chinese University of Hong Kong · Corewell Health East · HeartDrug Research LLC · Kagawa University · Mayo Clinic · Meir Medical Center · National Science and Technology Council, Taiwan · Queen Mary Hospital, Hong Kong · Region Skane · Samsung Medical Center · Sir Mortimer B. Davis - Jewish General Hospital · Texas Tech University Health Sciences Center · The Cleveland Clinic · The Rogosin Institute · The TIMI Study Group · United Christian Hospital · University of Colorado, Denver · Vanderbilt University · Vanderbilt University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Rasilez — 2007-08-22 europa.eu ↗
Approved US (FDA) TEKTURNA — 2007-03-05 fda.gov ↗

Trials 123 · started per year

today
US approved 2007
EU approved 2007
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200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT01568775 Jun → Sep 2010 end stage renal failure Novartis Completed No outcome recorded
Phase 1 NCT00424541 Jan → Aug 2007 hypertensive disorder Novartis Completed No outcome recorded
Phase 1 NCT00416728 Nov 2006 → ? — Novartis Completed No outcome recorded
Phase 1 NCT00416468 Nov 2006 → ? — Novartis Completed No outcome recorded
Phase 1 NCT00223717 Jan 2001 → Jan 2017 hypertensive disorder Vanderbilt University Completed No outcome recorded
Phase 1/24 trials · 2 met primary
Phase 1/2 NCT00834041 Apr 2009 → Jan 2010 hypertensive disorder Novartis Completed No outcome recorded
Phase 1/2 NCT00464776 Oct 2005 → Apr 2008 type 2 diabetes mellitus Novartis Completed Met primary
Phase 1/2 NCT00464880 Sep 2005 → Nov 2007 type 2 diabetes mellitus Novartis Completed Met primary
Phase 1/2 NCT00461136 Aug 2005 → Nov 2006 type 2 diabetes mellitus Novartis Completed No outcome recorded
Phase 215 trials · 1 met primary
Phase 2 NCT04183101 Oct 2020 → Dec 2029 expected C3 glomerulonephritis, dense deposit disease, membranoproliferative glomerulonephritis Region Skane Recruiting No outcome recorded
Phase 2 NCT01480791 Jan 2012 → Dec 2013 diabetes mellitus, hypertensive disorder Sir Mortimer B. Davis - Jewish General Hospital Withdrawn No outcome recorded
Phase 2 NCT01302899 Jan → Dec 2011 — Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT01125514 May 2010 → Aug 2011 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01080768 Feb → Nov 2010 hypertensive disorder Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT00939588 Jul → Dec 2009 hypertensive disorder Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00923156 May 2009 → Feb 2011 systolic heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00819767 Feb → Oct 2009 hypertensive disorder Novartis Completed No outcome recorded
Phase 2 NCT00768040 Sep 2008 → Feb 2011 diabetic macular edema Novartis Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00417170 Oct 2007 → Jul 2010 hypertensive disorder, metabolic syndrome X Novartis Pharmaceuticals Completed No outcome recorded
Phase 350 trials · 7 met primary · 7 missed
Phase 3 NCT01237873 Jan 2011 → Feb 2012 essential hypertension Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01259297 Jan 2011 → Nov 2012 — Novartis Pharmaceuticals Terminated Missed primary
Phase 3 NCT01151410 Aug 2010 → Aug 2015 hypertensive disorder Novartis Pharmaceuticals Completed Met primary
Phase 3 NCT01715207 Jun 2010 → Oct 2014 Marfan syndrome Samsung Medical Center Completed No outcome recorded
Phase 3 NCT01150357 Jun 2010 → Aug 2014 hypertensive disorder Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01113047 May → Oct 2010 essential hypertension Novartis Completed No outcome recorded
Phase 3 NCT00894387 May 2009 → Aug 2012 congestive heart failure Novartis Pharmaceuticals Completed Missed primary
Phase 3 NCT00870493 Apr 2009 → Mar 2012 IgA glomerulonephritis Chinese University of Hong Kong Completed No outcome recorded
Phase 3 NCT00853658 Mar 2009 → Oct 2015 heart failure Novartis Pharmaceuticals Completed Missed primary
Phase 3 NCT00867490 Mar → Aug 2009 hypertensive disorder Novartis Completed No outcome recorded
Phase 441 trials · 4 met primary · 1 missed
Phase 4 NCT01922141 May 2015 → Jun 2018 hypertensive disorder Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 4 NCT01570686 Apr → Nov 2012 hypertensive disorder Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT01235910 May 2011 → Dec 2012 hypertensive disorder University of Colorado, Denver Terminated No outcome recorded
Phase 4 NCT01368536 May 2011 → Feb 2012 hypertensive disorder, type 2 diabetes mellitus Novartis Pharmaceuticals Terminated No outcome recorded
Phase 4 NCT01138423 Aug 2010 → Feb 2012 hypertensive disorder, metabolic syndrome X UMC Utrecht Completed No outcome recorded
Phase 4 NCT01156207 Jul 2010 → Jul 2013 heart failure Taipei Veterans General Hospital, Taiwan Unknown No outcome recorded
Phase 4 NCT01176032 Jun 2010 → Apr 2013 hypertensive disorder, hypertensive heart disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT01184599 Jun 2010 → Mar 2013 IgA glomerulonephritis, hypertensive disorder Kagawa University Unknown No outcome recorded
Phase 4 NCT01095822 Mar → Dec 2010 diabetes mellitus HeartDrug Research LLC Unknown No outcome recorded
Phase 4 NCT01060865 Mar 2010 → Oct 2011 hypertensive disorder Meir Medical Center Terminated No outcome recorded
Phase not applicable8 trials
— NCT02446548 Mar 2013 → Apr 2014 proteinuria Medical University of Gdansk Completed No outcome recorded
— NCT01425242 Sep 2011 → Dec 2013 abdominal aortic aneurysm, essential hypertension Amsterdam UMC, location VUmc Terminated No outcome recorded
— NCT01093781 Nov 2010 → Dec 2011 idiopathic membranous glomerulonephritis Mayo Clinic Withdrawn No outcome recorded
— NCT01298258 Jul 2010 → Jul 2013 heart failure Taipei Veterans General Hospital, Taiwan Unknown No outcome recorded
— NCT01252238 Jun 2010 → Dec 2012 — Brigham and Women's Hospital Terminated No outcome recorded
— NCT01165983 Nov 2009 → Jan 2012 type 2 diabetes mellitus Beth Israel Deaconess Medical Center Completed No outcome recorded
— NCT00627861 Nov 2008 → May 2010 hypertensive disorder The Rogosin Institute Terminated No outcome recorded
— NCT00732407 Sep 2008 → Sep 2009 atherosclerosis, type 2 diabetes mellitus Assaf-Harofeh Medical Center Unknown No outcome recorded
Comparator or background therapy31 trials
Phase 1 NCT01217736 Comparator Sep 2010 → Nov 2011 impaired renal function disease Vitae Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01103245 Comparator Mar 2010 → Jul 2012 diabetes mellitus Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT00856960 Comparator Jan → Mar 2010 hypertensive disorder Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00933920 Comparator Jun → Dec 2009 hypertensive disorder Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00881439 Comparator Apr 2009 → Jul 2012 heart failure, kidney failure University Medical Center Groningen Terminated No outcome recorded

Evidence & citations 31 cited values

Every value below carries the sentence it was read from. 158 sources stand behind the page.

FieldValueCited text
Known as aliskiren “antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily” NCT01038895 ↗
152

“Valturna (aliskiren 150 mg/valsartan 160 mg) tablet” NCT01368536 ↗

“Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg” NCT01237873 ↗

NCT02909166 ↗

NCT00549757 ↗

NCT00344110 ↗

NCT00299806 ↗

NCT00631917 ↗

NCT01129557 ↗

NCT01040494 ↗

NCT00386139 ↗

Show 142 more sources

Known as ALISKIREN FUMARATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of amturnide aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of raprazo-hct aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of rasilamlo aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of rasilez-hct aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of rasitrio aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of sprimeo-hct aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of tekamlo aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of tekturna hct aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren fumarate component of valturna aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren hemifumarate component of amturnide ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren hemifumarate component of tekamlo ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskiren hemifumarate component of valturna ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskirene ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Aliskireno ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Enviage ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as NSC-759185 ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Rasilez “Aliskiren (Rasilez®) is a new antihypertensive drug” NCT01060865 ↗
1

“aliskiren (Rasilez 300 mg, Novartis Europharm” NCT01541267 ↗

Known as Riprazo ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as SPP-100B ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as SPP100 “We tested the new orally active nonpeptidic renin inhibitor SPP100 (Aliskiren, an octanamide with a 50% inhibitory concentration [IC50] in the low nanomolar range) in 18...” PMID 11799102 ↗ Jan 2002
5

“A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction” NCT00299832 ↗

“Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension” NCT00344110 ↗

“SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension” NCT00299806 ↗

“SPP100 (aliskiren)” NCT00424541 ↗

NCT00246584 ↗

Known as Sprimeo ChEMBL registry synonym — accepted as the source's own label CHEMBL1639 ↗
Known as Tekturna “This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood...” NCT00974922 ↗
3

“The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type...” NCT00994253 ↗

“Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months” NCT01129557 ↗

“Aliskiren (Tekturna) is a recently FDA-approved potent direct renin inhibitor” NCT01095822 ↗