Levosimendan is under clinical development by Tenax Therapeutics and currently in Phase III for Pulmonary Hypertension. According to GlobalData, Phase III drugs for Pulmonary Hypertension have a 59% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Levosimendan’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.

Levosimendan overview

Levosimendan (Simdax, Zimino) is a phenylhydrazine derivative, acts as calcium sensitizer. It is formulated as injectable concentrate solution and solution for intravenous route of administration. Simdax is indicated for the short-term treatment of acute severe chronic heart failure and pulmonary hypertension associated with heart failure, diastolic heart failure, aneurysmal subarachnoid hemorrhage and preserved ejection fraction.

It is under development for the treatment of low cardiac output syndrome, pulmonary hypertension patients with heart failure and preserved left ventricular ejection fraction (PH-HFpEF) and pulmonary hypertension with left heart failure. The drug candidate was also under development for ischemic stroke, septic shock, acute coronary syndrome with ST-segment elevation and sepsis.

Tenax Therapeutics overview

Tenax Therapeutics (Tenax) is a pharmaceutical company that develops and commercializes a portfolio of novel therapeutic products for serious cardiovascular and pulmonary diseases. The company’s lead product includes levosimendan(TNX-103), a calcium sensitizer developed for the treatment of patients with pulmonary hypertension associated with heart failure with PH-HFpEF. It also develops imatinib (TNX-201), a tyrosine kinase inhibitor, for the treatment of chronic myeloid leukemia. The company offers products in capsule and solid dosage forms. It partners with pharmaceutical companies to market products in the US and worldwide. Tenax is headquartered in Morrisville, North Carolina, the US.

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

This content was updated on 10 June 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.