Udenafil is under clinical development by Mezzion Pharma and currently in Phase III for Liver Diseases. According to GlobalData, Phase III drugs for Liver Diseases have a 22% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Udenafil’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

Udenafil overview

Udenafil (Udzire, Zydena) is a benzenesulfonamide derivative with vasodilatory activity. It is formulated as film-coated tablets, coated tablets for oral route of administration. It is under development for the treatment of Fontan associated liver disease.

It was under development for the treatment of single ventricle heart defects (Congenital Heart Disease), erectile dysfunction, benign prostatic hyperplasia, heart failure with preserved ejection fraction (HFpEF), and overactive bladder. The drug candidate was also under development for the treatment of chronic obstructive pulmonary disease, portal hypertension, Raynaud syndrome, pulmonary arterial hypertension, and alzheimer's disease.

Mezzion Pharma overview

Mezzion Pharma is a drug development company that develops, licenses and commercializes new drugs and remedies for various therapeutic indications. The company develops udenafil drugs for erectile dysfunction, benign prostatic hyperplasia, pulmonary arterial hypertension, hepatic portal hypertension, overactive bladder and chronic obstructive pulmonary disease. It partners with various pharmaceutical and biotechnology companies for its drug development activities. Mezzion Pharma is also engaged in exporting therapeutic drugs to other countries. It carries out the manufacturing of Fontan patient drugs with the trade name Jurvigo in the US. The company operates in the US and South Korea. Mezzion Pharma is headquartered in Seoul, South Korea.

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

This content was updated on 12 April 2024

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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 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.