Gilenya

Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Carcinoma in Situ + 2 more
Treatment
20 Active Studies for Gilenya

What is Gilenya

FingolimodThe Generic name of this drug
Treatment SummaryFingolimod is a drug used to treat symptoms of multiple sclerosis (MS). It works by blocking receptors that cause inflammation and damage to nerve cells. The drug was created by Novartis and approved by the FDA in 2010. Currently, Fingolimod is being studied as a potential treatment for the novel coronavirus (COVID-19). Clinical trials are expected to end in July 2020.
Gilenyais the brand name
image of different drug pills on a surface
Gilenya Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Gilenya
Fingolimod
2010
16

Effectiveness

How Gilenya Affects PatientsFingolimod is a drug used to treat multiple sclerosis and possibly COVID-19. It works by binding to certain receptors in the body, reducing inflammation in the brain for MS patients, and potentially in the lungs for COVID-19 patients. It may also cause a temporary slower heart rate and longer QT intervals.
How Gilenya works in the bodySphingosine-1-phosphate (S1P) is a molecule found in the body that binds to several different receptors. These receptors can be found in the immune, cardiovascular, pulmonary, and nervous systems. Fingolimod phosphate is a drug that binds to certain S1P receptors and helps reduce inflammation associated with multiple sclerosis. It does this by keeping some lymphocytes from leaving lymph nodes and preventing them from entering the central nervous system. While it isn't typically used to treat SARS-CoV-2 pneumonia, it may be helpful in preventing acute respiratory distress syndrome (ARDS) associated with COVID

When to interrupt dosage

The prescribed quantity of Gilenya is contingent upon the diagnosed condition, such as Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS) and Alternative Treatment. Dosage shifts in accordance with the method of delivery (e.g. Capsule - Oral or Capsule) noted in the accompanying table.
Condition
Dosage
Administration
Relapsing Remitting Multiple Sclerosis
, 0.5 mg, 0.25 mg
, Oral, Capsule, Capsule - Oral
Carcinoma in Situ
, 0.5 mg, 0.25 mg
, Oral, Capsule, Capsule - Oral
Multiple Sclerosis
, 0.5 mg, 0.25 mg
, Oral, Capsule, Capsule - Oral
Multiple Sclerosis
, 0.5 mg, 0.25 mg
, Oral, Capsule, Capsule - Oral
Alternative Treatment
, 0.5 mg, 0.25 mg
, Oral, Capsule, Capsule - Oral

Warnings

Gilenya has fifteen contra-indications, so it should not be employed in combination with any of the conditions in the subsequent table.Gilenya Contraindications
Condition
Risk Level
Notes
Atrioventricular Block
Do Not Combine
Atrioventricular Block
Do Not Combine
Stroke
Do Not Combine
Angina, Unstable
Do Not Combine
Transient Ischemic Attack (TIA)
Do Not Combine
Atrioventricular Block
Do Not Combine
Heart Decompensation
Do Not Combine
Sick Sinus Syndrome
Do Not Combine
Heart failure
Do Not Combine
Pulse Frequency
Do Not Combine
Atrioventricular Block
Do Not Combine
Pulse Frequency
Do Not Combine
Heart Attack
Do Not Combine
Pulse Frequency
Do Not Combine
Heart failure
Do Not Combine
There are 20 known major drug interactions with Gilenya.
Common Gilenya Drug Interactions
Drug Name
Risk Level
Description
Adenovirus type 7 vaccine live
Major
The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Fingolimod.
Ajmaline
Major
Fingolimod may increase the arrhythmogenic activities of Ajmaline.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Fingolimod.
Amiodarone
Major
Fingolimod may increase the arrhythmogenic activities of Amiodarone.
Anthrax vaccine
Major
The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Fingolimod.
Gilenya Toxicity & Overdose RiskThe toxic dose of fingolimod in rats is between 300-600mg/kg. If someone has an overdose of fingolimod, they may experience low blood pressure and a slow heartbeat, which can be treated with atropine. It is also possible to experience heart block or cardiotoxicity due to the drug's known side effect.
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Gilenya Novel Uses: Which Conditions Have a Clinical Trial Featuring Gilenya?

Currently, 44 active clinical trials are exploring the potential of Gilenya to combat active Secondary Progressive Multiple Sclerosis (SPMS), Multiple Sclerosis and Carcinoma in Situ.
Condition
Clinical Trials
Trial Phases
Multiple Sclerosis
12 Actively Recruiting
Phase 3, Phase 4, Phase 2
Relapsing Remitting Multiple Sclerosis
14 Actively Recruiting
Not Applicable, Phase 3, Phase 2, Phase 4, Early Phase 1
Alternative Treatment
0 Actively Recruiting
Carcinoma in Situ
3 Actively Recruiting
Not Applicable, Phase 4
Multiple Sclerosis
0 Actively Recruiting

Gilenya Reviews: What are patients saying about Gilenya?

5Patient Review
1/25/2016
Gilenya for Relapsing Form of Multiple Sclerosis
I've been taking Gilenya for five years and it's worked great for me. I only wish that Novartis would lower their price to make the drug more affordable.
5Patient Review
4/6/2016
Gilenya for Relapsing Form of Multiple Sclerosis
I've been dealing with MS since 1990 and on interferon b1b since 1995. Recently, the interferon was no longer helping me, so I switched to Gilenya about a year ago. The results have been amazing—I can walk long distances without issue and feel well enough to work a lot more.
5Patient Review
10/3/2020
Gilenya for Relapsing Form of Multiple Sclerosis
Gilenya has been an absolute wonder drug for me. I enrolled in a study for it 12 years ago after my second lesion and have not had any new ones since then. The only side effects I've experienced are slightly elevated liver enzymes and an increase in cold sores for the first six months.
5Patient Review
11/6/2015
Gilenya for Relapsing Form of Multiple Sclerosis
I was diagnosed in 2010 and started on Rebif. Within a year, I had a new lesion on my brain despite the treatment. My doctor was initially against Gilenya because it had only recently been approved; however, I've been doing much better since switching. I do have to get bloodwork and MRI's every few months, but that's a small price to pay for feeling normal again.
5Patient Review
1/11/2016
Gilenya for Relapsing Form of Multiple Sclerosis
I feel great and have experienced zero side effects!
4.3Patient Review
7/14/2016
Gilenya for Relapsing Form of Multiple Sclerosis
This drug has been helping me for the past four months. I wasn't taking anything before for my MS, but since starting this medication, I've experienced hair loss and some weight gain. I'm hoping to reverse those effects.
4Patient Review
7/24/2018
Gilenya for Relapsing Form of Multiple Sclerosis
I've been taking Gilenya for six months now and I haven't had any issues with side effects. I'm also really glad that I don't have to take Rebif shots anymore.
3.7Patient Review
11/24/2015
Gilenya for Relapsing Form of Multiple Sclerosis
I'd been using Avonex for 16 years, but the needles were really starting to wear on me. So I decided to switch over to Gilenya. However, after only three months, I got a cold that turned into bronchitis and then a sore throat and chills. It's been 12 weeks now and I'm still dealing with this! And it's not like MS is a cakewalk either. All in all, the pill form is so much easier than this constant coughing.
1Patient Review
3/15/2017
Gilenya for Relapsing Form of Multiple Sclerosis
I had to stop taking Gilenya because the side effects were getting intolerable. I was on it for 11 months, and while I liked that it was an oral medication, I started experiencing debilitating diarrhea and stomach pains. Even after a few months off the drug, I'm still having issues. Has anyone else gone through this?
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about gilenya

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Gilenya for MS work?

"Gilenya prevents white blood cells from crossing into the central nervous system and causing inflammation and damage."

Answered by AI

What are the side effects of Gilenya?

"Some of the more common side effects associated with taking Gilenya include headaches, issues with liver function as shown by abnormal liver tests, diarrhea, cough, flu, sinusitis, back pain, and abdominal pain. Additionally, some people may also experience pain in their arms or legs."

Answered by AI

What is Gilenya used for?

"The United States Food and Drug Administration has approved Gilenya for the treatment of relapsing forms of multiple sclerosis in patients aged ten and above, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease."

Answered by AI

What kind of medication is Gilenya?

"Gilenya is a medication used to treat relapsing multiple sclerosis (MS). It is available as 0.5 mg capsules and is taken once daily by mouth. Common side effects include cough, headache, back pain, and diarrhea."

Answered by AI

Clinical Trials for Gilenya

Image of University of Maryland, Baltimore in Baltimore, United States.

Ublituximab for Multiple Sclerosis

18 - 65
All Sexes
Baltimore, MD
The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.
Waitlist Available
Has No Placebo
University of Maryland, BaltimoreDaniel Harrison, MDTG Therapeutics, Inc.
Have you considered Gilenya clinical trials? We made a collection of clinical trials featuring Gilenya, we think they might fit your search criteria.Go to Trials
Image of Clinical Translational Research Center at CU Anschutz in Aurora, United States.

Vagus Nerve Stimulation for Multiple Sclerosis

18 - 65
All Sexes
Aurora, CO
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are: * Is stimulating the vagus nerve safe and feasible after demyelinating episodes? * Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis? Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control. Participants will: * Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months. * During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test. * At various timepoints in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.
Recruiting
1 Prior Treatment
Clinical Translational Research Center at CU AnschutzJeffrey Bennett, MD
Image of Georgia State University in Atlanta, United States.

Ublituximab for Multiple Sclerosis

18 - 55
All Sexes
Atlanta, GA
The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.
Phase < 1
Waitlist Available
Georgia State University (+1 Sites)
Have you considered Gilenya clinical trials? We made a collection of clinical trials featuring Gilenya, we think they might fit your search criteria.Go to Trials
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Intermittent Hypoxia for Multiple Sclerosis

18 - 75
All Sexes
Chicago, IL
This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.
Recruiting
Has No Placebo
Shirley Ryan AbilityLabMilap Sandhu, Pt, PhD
Have you considered Gilenya clinical trials? We made a collection of clinical trials featuring Gilenya, we think they might fit your search criteria.Go to Trials
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