CLINICAL TRIALS PROFILE FOR ENTRESTO

All Clinical Trials for ENTRESTO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02636283 ↗	Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease	Terminated	American Heart Association	Phase 2	2017-12-31	This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.
NCT02636283 ↗	Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease	Terminated	University of Minnesota	Phase 2	2017-12-31	This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.
NCT02636283 ↗	Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease	Terminated	University of Minnesota - Clinical and Translational Science Institute	Phase 2	2017-12-31	This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.
NCT02682719 ↗	Personalised Prospective Comparison of ARni With ArB in Patients With Natriuretic Peptide eLEvation	Active, not recruiting	Novartis Ireland Ltd	Phase 2	2015-12-16	Sacubitril-valsartan, an Angiotensin Receptor Blocker-Neprilysin Inhibitor (ARNI), currently marketed for the management of heart failure, has been shown to reduce cardiovascular morbidity and mortality in stage C heart failure with reduced ejection fraction. In stage C HFpEF, sacubitril-valsartan has also been shown to reduce left atrial volume index measured using echocardiography over a 9 month timeframe. The PARABLE study investigates the hypothesis that sacubitril-valsartan can provide benefits in terms of left atrial structure and function as well as left ventricular structure and function in asymptomatic (stage A/B HFpEF) patients. This is a prospective, randomised, double-blind, double-dummy, phase II study design. The patient population will have hypertension and/or diabetes together with preserved ejection fraction, elevated natriuretic peptide (NP) and abnormal left atrial volume index (LAVI, > 28 mL/m2).

Clinical Trial Conditions for ENTRESTO

Condition Name

Condition Name for ENTRESTO
Intervention	Trials
Heart Failure	14
Hypertension	5
Chronic Heart Failure	4
Heart Failure With Preserved Ejection Fraction	3

Condition MeSH

Condition MeSH for ENTRESTO
Intervention	Trials
Heart Failure	24
Hypertension	4
Ventricular Remodeling	3
Diabetes Mellitus, Type 2	3

Clinical Trial Locations for ENTRESTO

Trials by Country

Trials by Country for ENTRESTO
Location	Trials
United States	36
Canada	9
Ireland	5
Denmark	3
France	3

Trials by US State

Trials by US State for ENTRESTO
Location	Trials
Minnesota	5
Tennessee	4
Massachusetts	3
Ohio	3
Illinois	2

Clinical Trial Progress for ENTRESTO

Clinical Trial Phase

Clinical Trial Phase for ENTRESTO
Clinical Trial Phase	Trials
PHASE1	4
Phase 4	18
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ENTRESTO
Clinical Trial Phase	Trials
Recruiting	13
Completed	10
Not yet recruiting	7

Clinical Trial Sponsors for ENTRESTO

Sponsor Name

Sponsor Name for ENTRESTO
Sponsor	Trials
Brigham and Women's Hospital	4
Novartis Pharmaceuticals	4
Vanderbilt University Medical Center	3

Sponsor Type

Sponsor Type for ENTRESTO
Sponsor	Trials
Other	66
Industry	15
NIH	4

Entresto: Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 20, 2026

What are the latest developments in Entresto’s clinical trials?

Entresto (sacubitril/valsartan), developed by Novartis, is approved for heart failure with reduced ejection fraction (HFrEF). The latest clinical trial updates include:

• PIONEER-HF (NCT02998571): Focused on using Entresto in hospitalized patients with acute decompensated heart failure. Results showed significant reductions in NT-proBNP levels compared to enalapril, indicating improved outcomes. Data published in 2019 confirmed its safety and efficacy for this subgroup.

• PARAGON-HF (NCT01920711): Investigated heart failure with preserved ejection fraction (HFpEF). Enrolled 4,822 patients. Trial results released in 2020 showed no statistically significant improvement in the primary outcome but demonstrated some benefits in certain subgroups, such as women and patients with higher blood pressure.

• EMPEROR-Reduced (NCT03057951): Evaluating the drug in HFrEF patients, focusing on cardiovascular death and hospitalization. Preliminary data presented in 2021 suggest a reduction in combined endpoint events, reinforcing Entresto's benefit in broader heart failure populations.

• Ongoing Studies: Researchers are exploring potential benefits of Entresto in renal impairment and diabetic kidney disease, with Phase III trials like PARAMOUNT and ongoing observational studies.

How does the market landscape look for Entresto?

Market Size and Share

• Global Heart Failure Market: Valued at approximately USD 4.2 billion in 2022, forecasted to reach USD 5.6 billion by 2027, growing at 5.8% CAGR (Research and Markets, 2023).

• Entresto's Market Share: Estimated at 65% within the branded heart failure treatment segment, with Novartis capturing the majority of sales due to early FDA approval in 2015.

Regional Market Distribution

Region	Market Share	Growth Rate (2022-2027)	Notes
North America	70%	6.0%	Leading due to high adoption and reimbursement.
Europe	20%	5.5%	Growing adoption, reimbursement delays in some countries.
Asia-Pacific	5%	8.0%	Fastest growth, driven by aging populations.
Rest of World	5%	4.5%	Limited access and infrastructure challenges.

Key Competitors

• Dapagliflozin (Farxiga/Forxiga): Approved for heart failure, originally for diabetes, capturing market share.
• Empagliflozin (Jardiance): Recognized for cardiovascular benefits, competing for heart failure indications.
• Other ARNI (Angiotensin Receptor-Neprilysin Inhibitors): Limited, as Entresto remains the primary in class.

What are the projections for Entresto’s market growth?

Forecast Overview

• 2022-2027 CAGR: Estimated at 6%, driven by expanding indications and increased adoption in HFpEF and chronic kidney disease (CKD).
• 2027 Market Value: Projected to reach USD 7.3 billion globally.
• Drivers: Broader clinical validation, approvals for new indications, and increased awareness of Heart Failure management.

Barriers to Growth

• Pricing and Reimbursement: Cost remains an obstacle in some regions, delaying adoption.
• Generic Competition: Patent expiry anticipated in 2028, risking entry of generics, which could reduce prices and market share.

Summary of market dynamics

Aspect	Details
Market size (2022)	USD 4.2 billion
Expected size (2027)	USD 7.3 billion
CAGR (2022-2027)	6%
Main growth drivers	Expanded indications, increased awareness, regional expansion
Challenges	Cost and reimbursement issues, potential competition post-patent expiration

Key Takeaways

• Clinical trial data confirms Entresto’s efficacy in reducing hospitalization and improving outcomes in HFrEF, with ongoing studies in other heart failure populations.
• The current global heart failure treatment market is expanding, with Entresto holding a dominant position.
• The market is forecasted to grow at 6% annually until 2027, reaching USD 7.3 billion, supported by broader indications and regional expansion.
• Patent expiry in 2028 could introduce generic competitors, putting downward pressure on prices.
• Reimbursement policies and drug pricing will significantly influence future market penetration and growth.

Frequently Asked Questions

What are the primary indications for Entresto?

Initially approved for HFrEF, ongoing trials aim to extend its use to HFpEF, CKD, and diabetic kidney disease.

How does Entresto compare to other heart failure medications?

It offers superior outcomes in reducing cardiovascular death and hospitalization relative to traditional ACE inhibitors like enalapril, particularly in HFrEF.

What safeguards exist around Entresto's clinical use?

FDA and EMA approve it with warnings on hypotension, hyperkalemia, and renal impairment, especially in sensitive populations.

When does patent expiration occur, and what are the implications?

Patent expected in 2028, which may lead to generic versions emerging, impacting sales and pricing strategies.

Are there ongoing efforts to expand Entresto's approved indications?

Yes. Trials explore its role in HFpEF, CKD, and in combination therapies for broader cardiovascular and renal diseases.

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References

[1] Research and Markets. (2023). Heart Failure Treatment Market, 2022–2027.
[2] Novartis. (2020). Clinical Trial Data on Entresto for Heart Failure.
[3] U.S. Food and Drug Administration. (2015). Entresto (sacubitril/valsartan) approval.
[4] European Medicines Agency. (2015). EMA approves Entresto for Heart Failure.