Fingolimod
How it works: Keeping immune cells out of the brain →
Gilenya
EU: Approved in the EU since 2011US: FDA approved 2010
- Other names
- fingolimod hcl, fingolimod hydrochloride
- Molecule type
- Small molecule
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
- USGilenya|Tascenso Odt · Approved21 September 2010 Source
- EU/EEAGilenya · Authorised17 March 2011 Source
- EU/EEAFingolimod Accord · Authorised · Generic25 June 2020 Source
- EU/EEAFingolimod Mylan · Authorised · Generic18 August 2021 Source
- EU/EEAFingolimod Mylan · Application withdrawn · Generic18 August 2021 Source
Other regulatory events
- Application withdrawn · Fingolimod Mylan8 May 2020 Source
Safety communications
- EMA safety letter (DHPC) · 10 November 2020
Gilenya: Periodic safety update report Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
88,484 reports in total, 45,570 marked serious.
- Fatigue11,138
- Multiple sclerosis relapse7,928
- Headache7,434
- Dizziness5,511
- White blood cell count decreased4,054
- Gait disturbance3,939
- Hypoaesthesia3,879
- Lymphocyte count decreased3,627
- Fall3,553
- Nausea3,536
Trials
Key trials
Large trials with a reported result on their main goal.
- Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple
Running, not recruiting · Phase 3 · Relapsing MS · Met its main goal
- This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to
Terminated · Phase 3 · Progressive MS · Stopped: not working
- Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting
Completed · Phase 3 · Relapsing MS · Met its main goal
Running now
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- Study to Assess Effects of Ublituximab in Pediatric Participants With
Recruiting · Phase 2 / Phase 3 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years
Running, not recruiting · Phase 4 · Relapsing MS · Still running
Other trials (67)
Completed small trials, dose-finding studies and trials in other diseases.
- Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Scle
Status unknown · Phase 4 · MS (type not specified) · No results found
- Monitoring of drugs used in the treatment of multiple sclerosis
Completed · Phase 4 · MS (type not specified) · No results found
- Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in
Completed · Relapsing MS · No results found
- A multicentric, international study in order to compare the effectiven
Completed · Phase 4 · Relapsing MS
- ND
Terminated · Phase 4 · Relapsing MS · Stopped
- Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown · MS (type not specified) · No results found
- Impact of Fingolimod Adherence on Outcomes
Completed · MS (type not specified) · No results found
- A Study of Immune Phenotype Biomarkers in Patients With Relapsing Mult
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
Terminated · Phase 4 · Relapsing MS · Stopped
Trials where it is given as background therapy
- Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remi
Completed · Phase 2 / Phase 3 · Relapsing MS · Results posted, not judged
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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