GP-531 is under clinical development by ViCardia Therapeutics and currently in Phase II for Congestive Heart Failure (Heart Failure). According to GlobalData, Phase II drugs for Congestive Heart Failure (Heart Failure) have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how GP-531’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.

GP-531 overview

GP-531 is under development for treatment of chronic heart failure and acute heart failure. GP-531 is a second-generation adenosine regulating agent (ARA). The drug candidate amplify the body's broad-spectrum protective response the localized release of endogenous adenosine during episodes of cellular stress. Cellular stress, as occurs with ischemia and tissue hypoxia, triggers the breakdown of adenosine triphosphate (ATP). ATP is the key energy molecule of living cells. Endogenous adenosine has been termed a "retaliatory metabolite" that targets multiple pathways of cellular stress and myocardial injury to counter net ATP catabolism and, as such, acts as a key regulator of cellular energetics. Endogenous adenosine protects cells from multiple pathways of injury such as inflammation, apoptosis and necrosis. Endogenous adenosine levels have been shown to be elevated in heart failure patients but not sufficiently to be cardioprotective. It acts by targeting Adenosine Monophosphate Activated Protein Kinase (AMPK). The drug candidate is administered through intravenous route or oral route of administration. It was also under development for ventricular dysfunction in chronic advanced heart failure, myocardial ischemia and ischemia / reperfusion injury, ischemic heart failure. 

ViCardia Therapeutics overview

ViCardia Therapeutics (ViCardia) is a clinical-stage biopharmaceutical company. It discovers, develops, and commercializes novel therapies to treat heart failures. The company’s pipeline includes GP531, a potent, long-lasting, infusion therapy to treat mitochondrial dysfunction which leads to chronic and acute heart failures. ViCardia, through its pipeline product, focuses on developing a therapy that reverses the progression of the disease which leads to improved life expectancy and lower hospital readmission rates. Its product candidate acts as an Adenosine mono-phosphate kinase (AMPK) activator that stimulates glucose and fatty acid uptake to enhance the energy output of the mitochondria and increases the mechanical function of the heart. ViCardia is headquartered in San Francisco, California, the US.

For a complete picture of GP-531’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 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.