Empagliflozin is under clinical development by Boehringer Ingelheim International and currently in Phase II for Renal Stones/Calculi. According to GlobalData, Phase II drugs for Renal Stones/Calculi does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Empagliflozin LoA Report. 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.

Empagliflozin overview

Empagliflozin (Jardiance, BI 10773, Gibtulio, Jardianz) is an anti-diabetic drug, belongs to the class of blood glucose lowering drugs. It is formulated as coated tablets and film-coated tablets for oral route of administration. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated as an adjunct to diet, exercise and standard care therapy, to reduce the incidence of cardiovascular (CV) death in patients with type 2 diabetes and established CV disease who have inadequate glycemic control. Jardiance also indicated to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Jardiance is indicated in adults, as an adjunct to standard of care therapy, for the treatment of patients with heart failure with reduced ejection fraction. Jardiance is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance (empagliflozin) is indicated for the treatment of symptomatic chronic heart failure with preserved ejection fraction (HFpEF) in adults. Jardiance is indicated in adults as an adjunct to standard of care therapy for the treatment of chronic heart failure.

Empagliflozin is under development for the treatment of glycogen storage disease type 1b and type 2, postprandial hypoglycemia, end-stage kidney disease, pulmonary arterial hypertension and kidney stones. It is a new chemical entity. It is also under development for cardiovascular outcomes in chronic heart failure with reduced and preserved ejection fraction (Systolic and Diastolic heart failure), acute heart failure, acute decompensated heart failure and coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and chronic kidney disease.

The drug candidate was under development for the treatment of type 1 diabetes and post-myocardial infarction.

Boehringer Ingelheim International overview

Boehringer Ingelheim International (Boehringer), a subsidiary of CH Boehringer Sohn AG & Co KG, is a pharmaceutical company that develops, manufactures and markets pharmaceuticals, parasiticides, vaccines and therapeutics for unmet medical needs. It offers an array of products including human diseases, animal health care products, and biopharmaceuticals. The company’s products are used for the treatment central nervous system disorders, cardiometabolic diseases, respiratory diseases, cancer, immunology, and retinal diseases, among others. It also offers animal healthcare products for swine, ruminant, poultry, horses, and pets, among others. Boehringer is headquartered in Ingelheim am Rhein,Rhineland-Palatinate, Germany.

For a complete picture of Empagliflozin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 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.