Dapagliflozin propanediol is under clinical development by AstraZeneca 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 Dapagliflozin propanediol’s likelihood of approval (LoA) and phase transition for Diastolic Heart Failure took place on 20 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Dapagliflozin propanediol overview

Dapagliflozin (Forxiga, Edistride, Oxra, Gledepa, Duforzig, Kedgeo, Tapleo) belongs to anti diabetic agents class. It is formulated as film-coated tablets and tablets, coated tablets for oral route of administration. It is indicated for the treatment of type 2 diabetes in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as mono-therapy and as add-on combination, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in patients with type 2 diabetes with moderate renal failure who have an estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73m2 or more, and also as an adjunct treatment for the Type 1 Diabetes,  to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors, and for treatment of adults with chronic heart failure with reduced ejection fraction (systolic heart failure) to reduce the risk of cardiovascular death and hospitalization for heart failure.Forxiga is indicated in adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure and urgent heart failure visit. Forxiga is indicated to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). It is also indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression. It is also indicated in adults for the treatment of chronic kidney disease. Forxiga is also indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular and renal death in adults with chronic kidney disease (CKD). Dapagliflozin is under development for the treatment of metastatic pancreatic ductal adenocarcinoma, type 1 diabetes, type 2 diabetes and for cardiovascular and renal outcomes in chronic kidney disease and chronic (systolic and diastolic) heart failure. It was also under development for the treatment of non-alcoholic fatty liver disease, diabetic nephropathy, obesity, non-alcoholic steatohepatitis, coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and respiratory failure, portal hypertension. Dapagliflozin is also under development for the treatment of acute myocardial infarction (MI) or heart attack.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

Quick View Dapagliflozin propanediol LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dapagliflozin propanediol
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Infectious Disease
  • Metabolic Disorders
  • Respiratory
Key Developers
  • Sponsor Company: AstraZeneca
  • Originator: Bristol-Myers Squibb
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.