Levosimendan is under clinical development by Orion 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 Levosimendan’s likelihood of approval (LoA) and phase transition for Acute Coronary Syndrome took place on 28 May 2021, 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 Levosimendan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 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.

Quick View Levosimendan LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Levosimendan
Administration Pathway
  • Intravenous
  • Oral
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Infectious Disease
Key Developers
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.