(Sacubitril + valsartan) is under clinical development by Novartis and currently in Phase II for Hypertrophic Cardiomyopathy. According to GlobalData, Phase II drugs for Hypertrophic Cardiomyopathy have a 57% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Sacubitril + valsartan)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(Sacubitril + valsartan) overview

Sacubitril and Valsartan (Entresto, Neparvis, Uperio, LCZ696, Vymada, Entresto Sprinkle) is a fixed dose combination acts as an anti hypertensive and cardiovascular agent. It is formulated as film coated tablets and granules in capsules and film coated pellets within capsules for oral route of administration. Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction. Entresto also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. Entresto is indicated for the treatment of hypertension.
LCZ696 is a single molecule comprising molecular moieties of valsartan and NEP inhibitor prodrug sacubitril. Entresto is indicated for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the  incidence of cardiovascular death and heart failure hospitalization.
LCZ-696 is under development for the treatment of non-obstructive hypertrophic cardiomyopathy, and chronic heart failure with preserved and reduced ejection fraction (diastolic heart failure) (HF-PEF), left ventricular dysfunction and pediatric heart failure due to systemic left ventricle systolic dysfunction. It was also under development for the treatment of essential hypertension, post-acute myocardial infarction and systolic hypertension.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. Novartis conducts research in various disease areas through the BioMedical Research division. The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of (Sacubitril + valsartan)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.