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Ibudilast (also known as MN-166) is a tablet being developed for progressive MS by MediciNova. Following a successful phase 2 clinical trial, a phase 3 clinical trial is now being planned.

Current phase of trial:
Phase 2 completed
Type of MS:
Primary progressive MS and Secondary progressive MS

Find out more about ibudilast

How does ibudilast work?

Ibudilast is a phosphodiesterase inhibitor. It is thought to have anti-inflammatory effects and to protect against cell death, which may be beneficial in MS in reducing nerve cell loss.

How is ibudilast taken?

As a tablet, twice daily.

Latest ibudilast research

SPRINT-MS phase 2 clinical trial

A phase 2 trial involving 255 people with primary and secondary progressive MS finished in July 2020. The trial compared taking ibudilast twice a day for three months with placebo. Ibudilast was added to either Copaxone or beta interferon treatment, or taken on its own.

Initial results were published in a peer-reviewed journal in October 2018. The authors found ibudilast was safe and significantly reduced brain shrinkage (atrophy) compared with placebo. The data also suggested that ibudilast can slow disability progression as measured by the Expanded Disability Status Scale.

In 2019 further analysis of the trial data revealed that people with secondary progressive MS without relapses had the best response to the drug with the most reduction in risk of disability progression.

Find out more about this clinical trial

Read the full research paper 

After discussing this data with the US Food and Drug Administration (FDA), MediciNova are planning a follow-up phase 3 clinical trial involving people with secondary progressive MS. This trial will measure the effect of ibudilast on disability progression in people with secondary progressive MS without relapses.

 

 

Earlier research

Phase 2 trial in relapsing MS

A phase 2 clinical trial involving 297 people with relapsing MS finished in 2010. Participants took either ibudilast or a placebo (dummy drug) to compare the efficacy of ibudilast over two years.

Results of this clinical trial were published in a peer-reviewed journal in March 2010. The authors found that ibudilast did not reduce relapse rate or the number of new lesions on MRI scans compared to a placebo. However, the results did suggest that ibudilast might have a neuroprotective effect, as fewer of those taking ibudilast had confirmed disease progression at the end of the study. Ibudilast was also found to reduce brain atrophy (shrinkage).

Read the full research paper

What are the side effects of ibudilast?

Ibudilast was generally well tolerated during the SPRINT-MS trial. However reported side effects included gastrointestinal symptoms (nausea, diarrhoea, abdominal pain, and vomiting), depression, and headaches.

How does ibudilast compare with current therapies?

Ibudilast has not been directly compared to other treatments yet.

When is ibudilast likely to become available?

Ibudilast is currently in phase 2 trials for progressive MS. Initial results from the phase 2 trial look positive, but ibudilast still needs to go through larger phase 3 trials to fully test its effectiveness in progressive MS before it can be licensed.

In March 2016 it was announced that the US Food and Drug Administration (FDA), responsible for licensing drugs in the US, have granted ibudilast fast track status. This is designed to speed up the development and review of new treatments. It will enable MediciNova (the company developing ibudilast) to meet with the FDA more frequently and to submit applications for review earlier than they normally would.

We'll keep you informed on the progress of ibudilast.