Siponimod fumarate is under clinical development by Novartis 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 Siponimod fumarate’s likelihood of approval (LoA) and phase transition for Stroke took place on 22 Aug 2022, 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 Siponimod fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Siponimod fumarate overview

Siponimod fumarate (Mayzent / Wan Li Neng / Kiendra) belongs to the class of trifluoromethylbenzenes acts as an immunosuppressant.It is formulated as film coated tablets and tablets for oral route of administration. Siponimod fumarate is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. Mayzent is also indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS)with active disease evidenced by relapses or imaging features of inflammatory activity.

Siponimod fumarate (BAF-312) is under development for the treatment of secondary-progressive multiple sclerosis,  hemorrhagic stroke, pediatrics multiple sclerosis, relapsing multiple sclerosis. The drug candidate is administered through oral and intravenous routes. It acts by targeting S1P1/S1P5 receptors. It was also under development for the treatment of polymyositis and active dermatomyositis.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Siponimod fumarate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Siponimod fumarate
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Musculoskeletal Disorders
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.