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aliskiren

Phase 4FDA approved

Renal Function | Small molecule | Nephrology |Syndax Pharmaceuticals, Inc.|Trials Updated: Feb 29, 2016

aliskiren development status

FDA approval on record Sep 16, 2009
Approval holderNovartis
ApplicationNDA022217
Highest phase Phase 4 run by Novartis (NCT00654875)
Phase scored for SNDXPhase 1
Registered trials 75 across 10 sponsors since Dec 2004

aliskiren target and mechanism

Molecular targetREN
Target classInhibitor
ModalitySmall molecule

Also known as Tekturna

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

aliskiren clinical trials

aliskiren · 1 trial · 1 indication

Phase 1 1
NCT01217736Direct Renin Inhibition and the KidneyRenal Function
COMPLETED22 Analytics
PHASE1COMPLETED
Direct Renin Inhibition and the Kidney
Renal FunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

renal plasma flow
pre-dose to 6 hours post-dose

as measured by PAH clearance

Secondary Endpoints

glomerular filtration rate
pre-dose to 6 hours post-dose
RAAS pathway biomarkers
pre-dose to 24 hours post-dose
VTP-27999 concentrations
pre-dose to 24 hours post-dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
VTP-27999EXPERIMENTAL -
aliskirenACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
aliskirenDRUGsingle dose, tablet
placeboDRUGsingle dose, tablet
VTP-27999DRUGsingle dose, tablet
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male or female, 18-75 years of age * Female subjects must be postmenopausal or surgically sterilized. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by plasma serum...

Countries:United States
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Frequently asked questions about aliskiren

What is aliskiren?

Aliskiren is a small molecule direct renin inhibitor being studied for effects on renal function. It is an investigational therapy in Phase 1 clinical development. Syndax Pharmaceuticals, Inc. (ticker: SNDX) is the developer. The drug has been evaluated in a single completed Phase 1 trial involving 22 participants.

What does aliskiren target?

Aliskiren targets renin (REN), an enzyme in the renin-angiotensin system. As a direct renin inhibitor, aliskiren binds to renin and blocks its activity. This mechanism is intended to reduce angiotensin II formation and influence renal function. The target class is inhibitor, and the molecular target is REN.

Who is developing aliskiren?

Syndax Pharmaceuticals, Inc. (ticker: SNDX) is developing aliskiren. The company is the sponsor of the clinical program evaluating aliskiren in renal function. The drug is a small molecule direct renin inhibitor currently in Phase 1 development.

What phase is aliskiren in?

Aliskiren is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes one completed Phase 1 trial. No active trials are currently listed for aliskiren.

What clinical trials is aliskiren in?

Aliskiren has been studied in one completed Phase 1 trial, NCT01217736, titled "Direct Renin Inhibition and the Kidney." The trial enrolled 22 participants in the United States and evaluated renal function. It was placebo-controlled, not randomized, and not double-blind, and included healthy volunteers.