fingolimod
fingolimod: sourced relationships with 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
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| Novartis AG (NVS) Reported 2010-09-21 · Current development: unknownSource | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2021-03-05 · Current development: unknownSource | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2021-03-05 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (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
Which companies have sourced relationships with fingolimod?
fingolimod has dated SEC/FDA relationship records for 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, dated March 5, 2021.