Levosimendan by Orion for Acute Coronary Syndrome: Likelihood of Approval

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 acute coronary syndrome with ST-segment elevation, 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 and sepsis.

Orion overview

Orion develops, manufactures and markets human and veterinary pharmaceuticals, and active pharmaceutical ingredients (APIs). Its products include pharmaceuticals for the treatment of central nervous system disorders, cancer and respiratory diseases. The company’s pipeline encompasses investigational candidates for the treatment of amyotrophic lateral sclerosis, Parkinson’s disease, chronic obstructive pulmonary disease, and various cancer types. Orion’s client base consists of healthcare service providers and professionals, such as doctors, pharmacies, veterinarians, hospitals, healthcare centers, clinics and laboratories. The company sells its products in European markets through own sales network and in international markets through several partners and distributors. Orion is headquartered in Espoo, Finland.

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

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.