Aliskiren Hemifumarate Clinical Trials

Clinical Trials

Multiple clinical trials evaluate the clinical utility, pharmacodynamics, and therapeutic safety of aliskiren hemifumarate across Phase IV and unassigned phase studies. Sponsored by both commercial entities and academic research organizations, these investigations focus on hypertension, post-cardiac transplantation hypertension, and SARS-CoV-2 risk reduction. Although completed trials evaluated daily oral dosing regimens and renal oxygenation dynamics, other studies investigating cyclosporine interactions in heart transplant recipients or observational mortality metrics were terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04432350	Withdrawn	COVID\|Drug Effect\|Drug Interaction\|Risk Reduction	Tabula Rasa HealthCare	2020-06-12	--
NCT01570686	Completed	Hypertension	Novartis Pharmaceuticals\|Novartis	2012-04	Phase 4
NCT01519635	Completed	Hypertension	Centre Hospitalier Universitaire Vaudois	2011-10	Phase 4
NCT01235910	Terminated	Hypertension\|Cardiac Transplantation	University of Colorado Denver\|American Heart Association	2011-05	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Aliskiren Hemifumarate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aliskiren hemifumarate selectively binds to the S3bp binding pocket of renin, inhibiting its enzymatic activity and blocking the cleavage of angiotensinogen into angiotensin I. This blockade prevents subsequent angiotensin II production and aldosterone release, reducing vascular smooth muscle constriction and lowering systemic blood pressure in hypertensive clinical settings.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).