GILENYA

Peak

fingolimod hcl

Novartis

NDAORALCAPSULEPriority Review

Approved

Sep 2010

Lifecycle

Peak

Competitive Pressure

0/100

Clinical Trials

Mechanism of Action

metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of…

Indications (6)

relapsing forms of multiple sclerosis (MS)to include clinically isolated syndrome relapsing-remitting disease active secondary progressive disease older multiple sclerosis

Clinical Trials (5)

NCT04667949Phase 4Completed

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Started Feb 2021

98 enrolled

Relapsing Multiple Sclerosis (RMS)

NCT04480853Phase 4Recruiting

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis

Started Oct 2020

30 enrolled

Multiple Sclerosis

NCT04657744Phase 1Completed

Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).

Started Aug 2020

34 enrolled

Healthy

NCT05141669N/ACompleted

Impact of Fingolimod Adherence on Outcomes

Started May 2020

694 enrolled

Multiple Sclerosis

NCT03243721N/ACompleted

Gilenya's Impact on Cognitive Function and Thalamic Volumes

Started Oct 2017

20 enrolled