ReviewPharmacology research & perspectives2021
Exploring the Food and Drug Administration's review and approval of Entresto (sacubitril/valsartan).
Review in Pharmacology research & perspectives, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Target identification and assessment in the era of AI.Nature reviews. Drug discovery · 2026Review
- Effects of Qili Qiangxin granules in combination with Entresto on quantitative parameters of myocardial motion in patients with cardiomyopathy in end-stage renal disease.BMC cardiovascular disorders · 2026Article
- Rational Design of Amiodarone Co-crystals: A Synergistic Strategy Combining Computational Prediction, Precipitation-Inhibiting Polymers, and Formulation Optimisation.AAPS PharmSciTech · 2026Article
- Article
- Solubilization techniques used for poorly water-soluble drugs.Acta pharmaceutica Sinica. B · 2024Review
- Teaching an old drug new tricks: Regulatory insights for the repurposing of hemin in cardiovascular disease.Pharmacology research & perspectives · 2024Review
- Review
- The Impact of Sacubitril/Valsartan on Heart Failure Patient with Reduced Left Ventricular Ejection Fraction: Single Center Retrospective Study in Saudi Arabia.Drug, healthcare and patient safety · 2024Article
- Sacubitril/Valsartan in Heart Failure with Hypertension Patients: Real-World Experiences on Different Ages, Drug Doses, and Renal Functions.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2023Article
- Dabrafenib-Panobinostat Salt: Improving the Dissolution Rate and Inhibition of BRAF Melanoma Cells.ACS omega · 2023Article
- Hypertension and Type 2 Diabetes-The Novel Treatment Possibilities.International journal of molecular sciences · 2022Review
- Exploring the Food and Drug Administration's review and approval of Entresto (sacubitril/valsartan).Pharmacology research & perspectives · 2021Review
- Study of the possible effect of sacubitril/valsartan combination versus valsartan on the cognitive function in Alzheimer's disease model in rats.International journal of immunopathology and pharmacologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying its market approval. Using information extracted from Entresto's online approval package at Drugs@FDA, we explore some of the procedural complexities underlying market approval of new pharmaceuticals, discuss the broad pharmacological implications contained within regulatory agency grey literature, and highlight opportunities for future therapeutic development.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.