Sacubitrilat Clinical Trials

Size	Price	Qty
5mg	USD 269
25mg	USD 807

Clinical Trials

Multiple clinical trials are evaluating Sacubitrilat across Phase III and non-applicable phases for conditions including unruptured abdominal aortic aneurysm, metastatic epidural spinal cord compression, and female infertility. Sponsored by academic and pharmaceutical entities such as Rigshospitalet Denmark, the University of Miami in collaboration with Viewray Inc., and Ferring Pharmaceuticals, these studies reflect active research across distinct therapeutic fields. Recruitment statuses for these recorded protocols currently range from not yet recruiting to actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05575570	Not yet recruiting	Abdominal Aortic Aneurysm Without Rupture	Rigshospitalet Denmark	2024-11-01	Not Applicable
NCT06077071	Not yet recruiting	Metastatic Epidural Spinal Cord Compression\|Spinal Cord Compression	University of Miami\|Viewray Inc.	2024-06-01	Not Applicable
NCT06173869	Recruiting	Infertility Female	Ferring Pharmaceuticals	2024-03-29	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sacubitrilat directly binds to and inhibits neprilysin, thereby blocking the enzymatic degradation of endogenous vasoactive peptides and enhancing downstream cellular signaling that modulates vascular tone and extracellular matrix homeostasis. By suppressing peptide catabolism and mitigating adverse tissue remodeling, this biological activity provides mechanistic relevance to vascular and structural pathologies, including abdominal aortic aneurysm investigated in clinical evaluation.

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>).