Gilenya (Fingolimod)

Generic Name

Fingolimod

Brand Names

Gilenya, Tascenso Odt

FDA approval date: September 21, 2010

Classification: Sphingosine 1-phosphate Receptor Modulator

Form: Tablet, Capsule

What is Gilenya (Fingolimod)?

GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Approved To Treat

Multiple Sclerosis (MS)

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Related Clinical Trials

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)

Who is this study for: Patients with Multiple Sclerosis

Enrollment Status: Recruiting

Publish Date: May 29, 2026

Intervention Type: Drug

Study Drug: Fingolimod

Study Phase: Phase 4

Summary: The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.

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

Enrollment Status: Recruiting

Publish Date: April 28, 2026

Intervention Type: Other, Drug

Study Phase: Phase 3

Summary: The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer

Enrollment Status: Recruiting

Publish Date: March 30, 2026

Intervention Type: Drug

Study Phase: Phase 2

Summary: This is a single-institution, open-labeled study using fingolimod (FTY720/Gilenya) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) who have progressed on chemo-immunotherapy. The study design will be a 6 patient safety lead-in with 2 cohorts of patients for efficacy analysis where fingolimod 0.5 mg will be taken orally once daily.

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