Siponimod fumarate is under clinical development by Novartis and currently in Phase III for Multiple Sclerosis. According to GlobalData, Phase III drugs for Multiple Sclerosis have a 68% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Siponimod fumarate’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.

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, hematologic diseases, solid tumors, 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.

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

This content was updated on 2 September 2023

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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.