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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 · Approved2010-09-21 Source
  • EU/EEAGilenya · Authorised2011-03-17 Source
  • EU/EEAFingolimod Accord · Authorised · Generic2020-06-25 Source
  • EU/EEAFingolimod Mylan · Authorised · Generic2021-08-18 Source
  • EU/EEAFingolimod Mylan · Application withdrawn · Generic2021-08-18 Source

Other regulatory events

  • Application withdrawn · Fingolimod Mylan2020-05-08 Source

Safety communications

  • EMA safety letter (DHPC) · 2020-11-10

    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.

88,253 reports in total, 45,359 marked serious.

  • Fatigue11,124
  • Multiple sclerosis relapse7,891
  • Headache7,420
  • Dizziness5,504
  • White blood cell count decreased4,050
  • Gait disturbance3,934
  • Hypoaesthesia3,873
  • Lymphocyte count decreased3,624
  • Fall3,543
  • Nausea3,525

Trials

Key trials

Large trials with a reported result on their main goal.

  • Fingolimod, phase 3

    Running, not recruiting · Phase 3 · Relapsing MS · Main goal met

  • INFORMS

    Terminated · Phase 3 · Progressive MS · Stopped: no effect

  • Fingolimod, phase 3

    Completed · Phase 3 · Relapsing MS · Main goal met

  • Fingolimod, phase 3

    Completed · Phase 3 · Relapsing MS · Main goal met

  • TRANSFORMS

    Completed · Phase 3 · Relapsing MS · Main goal met

  • FREEDOMS

    Completed · Phase 3 · Relapsing MS · Main goal met

Running now

Other trials (67)

Completed small trials, dose-finding studies and trials in other diseases.

  • TDM-MS

    Status unknown · Phase 4 · MS (type not specified) · no_result_found

  • TERIFIN

    Completed · Phase 4 · MS (type not specified) · no_result_found

  • Fingolimod

    Completed · Relapsing MS · no_result_found

  • PRAG-MS

    Completed · Phase 4 · Relapsing MS

  • nd

    Terminated · Phase 4 · Relapsing MS · stopped_other

  • Fingolimod, phase 4

    Completed · Phase 4 · Relapsing MS · results_posted_no_test

  • STATURE

    Status unknown · MS (type not specified) · no_result_found

  • Fingolimod

    Completed · MS (type not specified) · no_result_found

  • FLUENT

    Completed · Phase 4 · Relapsing MS · results_posted_no_test

  • PRAG-MS

    Terminated · Phase 4 · Relapsing MS · stopped_other

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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