Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Siponimod · 1 trial · 3 indications
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date of the last actual administration, or events present prior to start of treatment but which increased in severity. TEAEs suspected to be related to study drug are reported.
| Arm | Type | Description |
|---|---|---|
| Siponimod | EXPERIMENTAL | Participants will receive titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod will start directly with 2 mg dose of siponimod. |
| Name | Type | Description |
|---|---|---|
| Siponimod | DRUG | Siponimod 2mg tablets taken once daily |
Key Inclusion Criteria: 1. Signed informed consent. 2. Male or female aged 18 to 65 years (inclusive). 3. Patients with advancing RMS as defined by the principal investigator. 4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lub...
Siponimod is used for the treatment of Multiple Sclerosis, specifically in patients with relapsing, advancing, or relapsing-remitting forms of the disease. It is an oral small molecule being developed by Novartis AG for this neurological condition.
Siponimod is a small molecule that modulates the sphingosine 1-phosphate receptor. By targeting this receptor, it is believed to reduce the migration of lymphocytes into the central nervous system, which is thought to play a role in the inflammatory process of Multiple Sclerosis.
Siponimod is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded under the ticker symbol NVS on the New York Stock Exchange.
Siponimod is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains under clinical investigation.
Siponimod has one completed Phase 3 clinical trial registered under NCT03623243. This trial, titled 'Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients,' enrolled 185 participants in the United States and Puerto Rico.
Yes, Siponimod is also known as Mayzent. The clinical trial NCT03623243 refers to Siponimod by its brand name Mayzent, indicating that these names are used interchangeably for the same drug.