(Sacubitril + valsartan) is under clinical development by Novartis and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect (Sacubitril + valsartan)’s likelihood of approval (LoA) and phase transition for Post-Myocardial Infarction took place on 07 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Sacubitril + valsartan) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Sacubitril + valsartan) overview

Sacubitril and Valsartan (Entresto, Neparvis, Uperio, Azmarda, LCZ696, Vymada) is a fixed dose combination acts as an anti hypertensive and cardiovascular agent. It is formulated as film coated tablets 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, post-acute myocardial infarction 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 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, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). 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.

Quick View (Sacubitril + valsartan) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • (Sacubitril + valsartan)
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.