Aliskiren

Overview

Aliskiren is the first drug in the renin inhibitor drug class and is used for the treatment of hypertension. It was developed by Speedel and Novartis and initially approved by the FDA in early 2007. Aliskiren has been proven to efficacious in reducing blood pressure when used alone or in conjunction with other antihypertensive agents.

Background

Indication

Aliskiren is used for the treatment of hypertension in children above 6 years and adults. This drug may also be used in conjunction with antihypertensives such as calcium channel blockers and thiazides in products form to provide additional blood pressure control.

Associated Conditions

Hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia	2024/12/05	NCT06718062	Phase 4	Completed	Hansung University
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy	2019/12/03	NCT04183101	Phase 2	Recruiting	Region Skane
The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function	2017/04/14	NCT03115853	Phase 4	Completed	Vanderbilt University Medical Center
Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF.	2016/09/21	NCT02909166	Phase 3	UNKNOWN	Mika Lehto
Influence of Aliskiren on Albuminuria After Kidney Transplantation	2015/05/18	NCT02446548	Not Applicable	Completed	Medical University of Gdansk
Aliskiren Study of Safety and Efficacy in Senior Hypertensives	2013/08/14	NCT01922141	Phase 4	Withdrawn	Novartis Pharmaceuticals
Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy	2013/07/09	NCT01893788	Phase 4	UNKNOWN	Nagoya University
RAS Quantification in Patients With Aliskiren or Candesartan	2013/04/09	NCT01827202	Phase 4	Completed	Medical University of Vienna
Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS	2012/10/26	NCT01715207	Phase 3	Completed	Samsung Medical Center
RAAS Inhibitor Drugs in Dialysis Patients	2012/07/09	NCT01635387	Phase 4	UNKNOWN	University of Campania "Luigi Vanvitelli"

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tekturna	LXO US Inc.	70839-150	ORAL	150 mg in 1 1	3/7/2024
Tekturna HCT	Noden Pharma USA, Inc.	70839-112	ORAL	150 mg in 1 1	11/16/2022
Tekturna	LXO US Inc.	70839-300	ORAL	300 mg in 1 1	3/7/2024
TEKTURNA	A-S Medication Solutions	50090-2985	ORAL	300 mg in 1 1	12/21/2023
ALISKIREN	Par Pharmaceutical, Inc.	49884-425	ORAL	300 mg in 1 1	3/25/2019
Tekturna HCT	Noden Pharma USA, Inc.	70839-325	ORAL	300 mg in 1 1	11/16/2022
Aliskiren	Prasco Laboratories	66993-142	ORAL	300 mg in 1 1	5/25/2023
ALISKIREN	Par Pharmaceutical, Inc.	49884-424	ORAL	150 mg in 1 1	3/25/2019
Tekturna HCT	Noden Pharma USA, Inc.	70839-312	ORAL	300 mg in 1 1	11/16/2022
Tekturna HCT	Noden Pharma USA, Inc.	70839-125	ORAL	150 mg in 1 1	11/16/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Rasilez	Noden Pharma DAC,D'Olier Chambers,16A D'Olier Street,Dublin 2,Ireland	Authorised	8/22/2007
Rasilez	Noden Pharma DAC,D'Olier Chambers,16A D'Olier Street,Dublin 2,Ireland	Authorised	8/22/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Aliskiren Tablets	Lee's Pharmaceutical Taiwan Limited	国药准字HC20191004	化学药品	片剂	2/2/2021
Aliskiren Tablets	Lee's Pharmaceutical Taiwan Limited	国药准字HC20191005	化学药品	片剂	2/2/2021
Aliskiren Tablets	Lee's Pharmaceutical Taiwan Limited	国药准字HC20191006	化学药品	片剂	2/2/2021
Aliskiren Tablets	Lee's Pharmaceutical Taiwan Limited	国药准字HC20191007	化学药品	片剂	2/2/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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