Overview
Sacubitril is a prodrug neprilysin inhibitor used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It was approved by the FDA after being given the status of priority review for on July 7, 2015. Sacubitril's active metabolite, LBQ657 inhibits neprilysin, a neutral endopeptidase that would typically cleave natiuretic peptides such as atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP). ANP and BNP are released under atrial and ventricle stress, which activate downstream receptors leading to vasodilation, natriuresis and diuresis. Under normal conditions, neprilysin breaks down other vasodilating peptides and also vasoconstrictors such as angiotensin I and II, endothelin-1 and peptide amyloid beta-protein. Inhibition of neprilysin therefore leads to reduced breakdown and increased concentration of endogenous natriuretic peptides in addition to increased levels of vasoconstricting hormones such as angiotensin II.
Indication
Used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB. It is also used in combination with valsartan.
Associated Conditions
- Cardiovascular Mortality
- Heart Failure
- Hospitalization due to cardiac failure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/15 | Phase 2 | Completed | National Heart Institute, Egypt | ||
2025/04/10 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2024/12/02 | Phase 3 | Not yet recruiting | Puerta de Hierro University Hospital | ||
2024/11/26 | Phase 4 | Not yet recruiting | Martin Rohacek | ||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/02/22 | Phase 1 | Not yet recruiting | |||
2024/02/20 | Phase 1 | Not yet recruiting | |||
2024/02/08 | Phase 1 | Not yet recruiting | |||
2024/01/05 | Phase 1 | Not yet recruiting | Dr. Reddy's Laboratories (Thailand) Limited | ||
2023/11/29 | N/A | Recruiting | University Hospital, Grenoble |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0777 | ORAL | 49 mg in 1 1 | 8/12/2025 | |
| Lupin Pharmaceuticals, Inc. | 70748-197 | ORAL | 97 mg in 1 1 | 7/29/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-1238 | ORAL | 15 mg in 1 1 | 8/12/2025 | |
| Lupin Pharmaceuticals, Inc. | 70748-196 | ORAL | 49 mg in 1 1 | 7/29/2025 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-806 | ORAL | 49 mg in 1 1 | 3/28/2024 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-810 | ORAL | 24 mg in 1 1 | 4/2/2024 | |
| Novartis Pharmaceuticals Corporation | 0078-1231 | ORAL | 6 mg in 1 1 | 8/12/2025 | |
| Lupin Pharmaceuticals, Inc. | 70748-195 | ORAL | 24 mg in 1 1 | 7/29/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-9659 | ORAL | 24 mg in 1 1 | 8/12/2025 | |
| Novartis Pharmaceuticals Corporation | 0078-0696 | ORAL | 97 mg in 1 1 | 8/12/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/19/2015 | ||
Authorised | 11/19/2015 | ||
Authorised | 5/26/2016 | ||
Authorised | 5/26/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MERAVO FILM-COATED TABLETS 200MG | SIN16874P | TABLET, FILM COATED | 97mg | 9/28/2023 | |
| MERAVO FILM-COATED TABLETS 50MG | SIN16872P | TABLET, FILM COATED | 24mg | 9/28/2023 | |
| MERAVO FILM-COATED TABLETS 100MG | SIN16873P | TABLET, FILM COATED | 49mg | 9/28/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| NEPARVIS 24 MG/26 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161103001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| NEPARVIS 49 MG/51 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161103003IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ENTRESTO 49 MG/51 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058003IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ENTRESTO 24 mg/26 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058001IP1 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ENTRESTO 97 MG/103 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058006IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ENTRESTO 97 MG/103 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058006IP3 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| NEPARVIS 97 MG/103 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161103006IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ENTRESTO 49 mg/51 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058003IP1 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ENTRESTO 24 MG/26 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 151058001IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| NEPARVIS 24 MG/26 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 161103001IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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