Clinical Trials

Multiple clinical trials evaluate sacubitril across diverse heart failure presentations, including heart failure with reduced ejection fraction, de novo heart failure, and cancer therapy-related heart dysfunction. Spanning Phase 1/2 through Phase 4 implementation protocols alongside non-phased designs, these studies are sponsored by major pharmaceutical companies like Novartis as well as academic medical centers including Stanford University, Virginia Commonwealth University, and Universidade do Porto. The portfolio reflects varied recruitment statuses, ranging from active recruitment and completed cohorts to withdrawn studies and protocols enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05989503 Recruiting
Heart Failure With Reduced Ejection Fraction
Universidade do Porto|Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)|Rede de Investigação em Saúde
 2023-08-04 Phase 4
NCT05870709 Withdrawn
Heart Failure
Novartis Pharmaceuticals|Novartis
 2023-05-15 --
NCT05564572 Enrolling by invitation
Heart Failure
Stanford University
 2022-09-07 Not Applicable
NCT05194111 Recruiting
Heart Failure|Heart Dysfunction
Virginia Commonwealth University
 2022-08-11 Phase 1|Phase 2
NCT05963282 Completed
de Novo Heart Failure
Novartis Pharmaceuticals|Novartis
 2021-11-29 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sacubitril acts as a prodrug that, upon conversion to its active metabolite, potently binds to and inhibits neprilysin, thereby blocking the enzymatic breakdown of endogenous vasoactive peptides such as atrial and B-type natriuretic peptides. This inhibition preserves peptide activity to enhance downstream cyclic GMP signaling, promoting vasodilation, diuresis, and attenuation of adverse cardiac remodeling in clinical conditions such as heart failure with reduced ejection fraction and therapy-associated cardiac dysfunction.

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>).

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Note: Technical data last updated: Sep 1, 2026.