fingolimod
fingolimod: developed by 2 companies · 7 clinical trials tracked · 2 FDA decisions.
fingolimod evidence translation
What we can confirm
2 FDA records · 7 tracked trials
What it means
What to watch
Prepared research question
What is verified about fingolimod, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 3 study sponsors
Development Pipeline (3)
| Company | Phase |
|---|---|
| Novartis AG (NVS) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (7)
A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis
Primary endpoint: TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation
Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Primary endpoint: Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab
A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Primary endpoint: Annualized relapse rate (ARR)
A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension
Primary endpoint: Annualized relapse rate (ARR) in target pediatric participants
Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Primary endpoint: Number of Major Congenital Malformations (MCMs)
A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)
Primary endpoint: Number of Adverse Events of Special Interest(AESI)
A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase
Primary endpoint: Frequency of Relapses in Patients Treated for up to 24 Months
FDA Decisions2 records
Frequently asked questions
Who is developing fingolimod?
fingolimod is being developed by Novartis AG, DR REDDYS LABORATORIES LTD.
How many clinical trials involve fingolimod?
BioSniper tracks 7 clinical trials involving fingolimod.
What is fingolimod's latest FDA decision?
The most recent tracked FDA decision for fingolimod is Approval for 1 INDICATIONS AND USAGE Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary p, dated March 5, 2021.