Gilenya

Relapsing Remitting Multiple Sclerosis, Multiple Sclerosis, Carcinoma in Situ + 2 more

Treatment

20 Active Studies for Gilenya

What is Gilenya

Fingolimod

The Generic name of this drug

Treatment Summary

Fingolimod 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.

Gilenya

is 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 Patients

Fingolimod 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 body

Sphingosine-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

Capsule - Oral, , Oral, Capsule

Carcinoma in Situ

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Multiple Sclerosis

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Multiple Sclerosis

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

Alternative Treatment

, 0.5 mg, 0.25 mg

Capsule - Oral, , Oral, Capsule

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 Risk

The 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.

image of a doctor in a lab doing drug, clinical research

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?

5

Patient 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.

5

Patient 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.

5

Patient 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.

5

Patient 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.

5

Patient Review

1/11/2016

Gilenya for Relapsing Form of Multiple Sclerosis

I feel great and have experienced zero side effects!

4.3

Patient 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.

4

Patient 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.

3.7

Patient 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.

1

Patient 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 Illinois at Chicago in Chicago, United States.

Functional Balance Intervention for Multiple Sclerosis

40 - 90
All Sexes
Chicago, IL

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

Recruiting
Has No Placebo

University of Illinois at Chicago

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 Sandoz Investigational Site in Maitland, United States.

CYB704 vs Ocrevus for Multiple Sclerosis

18 - 55
All Sexes
Maitland, FL

The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will: * Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU) * Visit the clinic for at least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

Phase 3
Recruiting

Sandoz Investigational Site (+1 Sites)

Sandoz

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 Anschutz

Jeffrey 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
Image of Shirley Ryan AbilityLab in Chicago, United States.

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 AbilityLab

Milap 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