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Fingolimod (also known as Gilenya) is a tablet developed by Novartis for relapsing MS. A phase 3 clinical trial testing fingolimod as a treatment for primary progressive MS was reported to be unsuccessful in 2016.

Current phase of trial:
phase 3 unsuccessful

Find out more about fingolimod

How does fingolimod work?

Fingolimod works by trapping a certain type of immune cell (called a T cell) in the body's lymph nodes. This stops them from getting into the brain and spinal cord, where they would cause damage to the protective myelin covering around the nerves.

How is fingolimod taken?

Fingolimod is taken as a tablet once a day.

Latest research

The INFORMS trial

This phase 3 trial compared fingolimod with placebo and involved 940 people with primary progressive MS. Results were published in February 2016. Fingolimod did not delay disability progression compared with placebo.

What are the side effects of fingolimod?

Common side effects include headaches, respiratory infection, shortness of breath, diarrhoea and nausea.

Cases of localised skin cancer have been reported in people taking Gilenya. The tablet may also cause swelling to the back of the eye (macular oedema), but this is considered a less common side effect.

How does fingolimod compare with current therapies?

There are currently no licensed treatments for primary progressive MS.

When is fingolimod likely to become available?

Phase 3 trial results (INFORMS) were negative. No further trials for primary progressive MS are planned, and therefore fingolimod will not be licensed to treat primary progressive MS.

Whilst these results are disappointing, the way in which disability was assessed in the INFORMS trial may prove useful in future clinical trials for primary progressive MS.