Product Description
Sacubitril/valsartan is the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI). The medication is FDA-approved to treat patients with chronic heart failure with reduced ejection fraction (HFrEF) with NYHA class II, III, or IV. Sacubitril/valsartan is to be used in place of an ACEI or angiotensin II receptor blocker (ARB) and in conjunction with other standard, heart-failure treatments (beta-blocker, aldosterone antagonist). (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK507904/)
Mechanisms of Action: ARN Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Heart Failure | Heart Failure, Chronic | Heart Failure, Systolic | Heart Block | Heart Failure | Myocardial Infarction | Ventricular Dysfunction | Ventricular Dysfunction, Left | Hypertension | Stroke | Heart Block | Heart Failure | Myocardial Infarction | Ventricular Dysfunction | Ventricular Dysfunction, Left | Hypertension | Stroke | Hypertension
Known Adverse Events: Hypotension | Dizziness | Hyperkalemia | Kidney Diseases | Heart Failure | Myocardial Infarction | Hypertension | Abdominal Pain | Back Pain | Headache | Pain Unspecified | Arthralgia | Diarrhea | Heart Block | Drug Hypersensitivity | General Diabetes | Hypertension, Renal | Nasopharyngitis | Pharyngitis
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 26
Highest Development Phases
Phase 3: Heart Failure|Heart Failure, Chronic|Heart Failure, Diastolic|Hypertension|Myocardial Infarction
Phase 2: Arthritis|Breast Cancer|COVID-19|Cardiomyopathies|Cardiomyopathy, Hypertrophic|Heart Cancer|Male Breast Cancer|Obesity|Type 2 Diabetes
Phase 1: Healthy Volunteers|Kidney Diseases|Nephrotic Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RESILIENCE | P2 |
Not yet recruiting |
Arthritis|Hypertension|Obesity|Type 2 Diabetes |
2028-11-26 |
|
| jRCT2031230703 | P3 |
Not yet recruiting |
Hypertension |
2026-03-31 |
|
| A119_01HTN2312 | P3 |
Not yet recruiting |
Hypertension |
2025-12-31 |
|
| CLAZ696B11302 | P3 |
Recruiting |
Hypertension |
2025-08-15 |