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Drug

Aliskiren

Approved · EMA
Emerging researchLate-stage development
Also known as Amturnide, Tekamlo, Tekturna, Tekturna HCT+2 more

Amturnide, Tekamlo, Tekturna, Tekturna HCT, Valturna, Aliskireno.

RxNorm325646ChEMBLCHEMBL1639UNII502FWN4Q32
2
Research papers
1
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy

Clinical trial2025-06-22Results expected Q4 2029 · ClinicalTrials.gov

Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

Clinical trial2024-10-01Completed · ClinicalTrials.gov

A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

Clinical trial2021-06-07Results posted · ClinicalTrials.gov

A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension

Clinical trial2020-12-21Completed · ClinicalTrials.gov

A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension.

Clinical trial2020-08-06Results posted · ClinicalTrials.gov

Effect of Aliskiren 300mg and Hydrochlorothiazide 25mg on Kidney Oxygenation in Patients With Stage 1 and 2 Hypertension: a BOLD-MRI Study

Clinical trial2020-03-17Results posted · ClinicalTrials.gov

A Randomized, Blinded, Placebo-Controlled Six Month Treatment Trial of Aliskiren to Improve Exercise Tolerance in Older Patients With Heart Failure and Normal Ejection Fraction

Clinical trial2019-02-27Results posted · ClinicalTrials.gov

Drug Safety Update: Aliskiren (Rasilez▼): risk of angioedema and renal dysfunction

Regulatory2014-12-11MHRA

Drug Safety Update: Aliskiren (Rasilez▼): risk of cardiovascular and renal adverse reactions

Regulatory2014-12-11MHRA

Effects of high- and low-sodium diets on ambulatory blood pressure in patients with hypertension receiving aliskiren.

Research2010-09-27Journal of cardiovascular pharmacology and therapeutics

Approval: Rasilez (EMA)

Regulatory2007-08-22EMA

Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial.

Research2007-07-01Lancet (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Aliskiren
Aliases & brands
AmturnideTekamloTekturnaTekturna HCTValturnaAliskireno
RxNorm CUI
325646
ChEMBL ID
CHEMBL1639
UNII
502FWN4Q32
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-08-22
Latest approval
2007-08-22
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2007-08-22Approval
Approval: Rasilez (EMA)

Indication: Treatment of essential hypertension.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Aliskiren (Rasilez▼): risk of cardiovascular and renal adverse reactions
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Aliskiren (Rasilez▼): risk of angioedema and renal dysfunction
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

123 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
123
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
100
Late-stage (III+)
88
Completed
34
Discontinued
PHASE DISTRIBUTIONn = 123
Phase 18Phase 1 / 23Phase 212Phase 2 / 31Phase 347Phase 443Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

CompletedPH IVHansung Universityn=662024

A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Follow-up to Compare Long-term Safety of an Aliskiren-based Regimen to a Ramipril-based Regimen in Hypertensive Patients ≥ 65 Years of Age

WithdrawnPH IVNovartis Pharmaceuticals2018

Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Unknown statusPH IVNagoya Universityn=1002016

Renin-Angiotensin-System Quantification in Patients Treated With Aliskiren or Candesartan (RASQAL)

CompletedPH IVMedical University of Viennan=242016

Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2

CompletedPH IVShiga Universityn=2372014

Recent completions

Trials that read out recently, adding to the completed evidence base.

Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

CompletedPH IVHansung Universityn=662024

The Pathophysiology and Treatment of Supine Hypertension in Patients With Autonomic Failure

CompletedPH IVanderbilt Universityn=1522017

Renin-Angiotensin-System Quantification in Patients Treated With Aliskiren or Candesartan (RASQAL)

CompletedPH IVMedical University of Viennan=242016

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

CompletedPH IIIKey trialNovartis Pharmaceuticalsn=7,0642015

A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

CompletedPH IIINovartis Pharmaceuticalsn=2082015

Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol

CompletedPH IIISamsung Medical Centern=302014

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20072010
Major research themes2
Diet, Sodium-Restricted1Renin Inhibitors1
Journals, researchers & institutions
Top journals
  • Journal of cardiovascular pharmacology and therapeutics1
  • Lancet (London, England)1
Leading researchers
  • Charney AN1
  • Fang H1
  • Oparil S1
  • Patel S1
  • Purkayastha D1
  • Satlin A1
  • Weir MR1
  • Yadao AM1
Leading institutions
free-text, unnormalised
  • University of Alabama at Birmingham1
  • University of Maryland School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.