Other names: BIIB098, Vumerity
Diroximel fumarate is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet twice daily.
Diroximel fumarate for relapsing remitting MS: Phase III
- Diroximel fumarate has biological activity similar to Tecfidera. In the body, both drugs are converted to monomethyl fumarate which reduces inflammation caused by MS activity and may protect nerve cells from damage.
- In relapsing remitting MS, diroximel fumarate reduced relapse rates and improved MRI measures of MS activity.
- In healthy participants, the most common side effects were were flushing, dizziness, and constipation. It is predicted that diroximel fumarate will have fewer gastrointestinal side effects than Tecfidera.
How does diroximel fumarate work?
Diroximel fumarate is similar to Tecfidera (chemical name dimethyl fumarate). In the body, both drugs are converted to monomethyl fumarate. It is predicted that diroximel fumarate will cause fewer gastrointestinal side effects.
In common with Tecfidera, the way diroximel fumarate works is not fully understood, but laboratory studies suggest that it may work in two ways:
How is diroximel fumarate taken?
Diroximel fumarate is taken as a tablet, twice daily.
Diroximel fumarate research
What are the results so far?
A phase I study in 35 people without MS indicated that diroximel fumarate had a very similar biological activity to Tecfidera.
What further research is planned?
EVOLVE-MS-1 - diroximel fumarate
This phase III study is evaluating the safety and tolerability of diroximel fumarate, taken for approximately 2 years, in 935 participants with relapsing remitting MS. The main purpose of the study is to record the level of side effects.
Estimated completion date December 2020.
Further details of the study.
Interim results from this study were presented at a scientific meeting in 2018. After one year of treatment with diroximel fumarate, the annualized relapse rate of 570 participants was 0.16. MRI results in a subset of these participants showed an improvement in measures of MS activity, compared to when they first joined the trial. Data from the first three months of the study showed that diroximel fumarate was well tolerated, with low levels of discontinuation of treatment due to gastrointestinal side effects.
EVOLVE-MS-2 - diroximel fumarate compared to Tecfidera (dimethyl fumarate)
This phase III study is recruiting 500 participants with relapsing remitting MS who will take either diroximel fumarate or Tecfidera for 5 weeks in order to compare gastrointestinal side effects. The main measure will be the number of days that participants experience gastrointestinal symptoms.
Estimated completion date June 2019.
Further details of the study.
It is proposed that diroximel fumarate will have fewer gastrointestinal side effects than Tecfidera.
In the phase I study the most common adverse effects were flushing, dizziness, and constipation.
- Neurology 2018; 90 (15 Supplement): P6.360. Summary EVOLVE-MS-1: A Phase 3, Open-Label, Long-Term Safety Study of ALKS 8700 in Relapsing-Remitting Multiple Sclerosis (P6.360)
- Neurology 2018; 90 (15 Supplement): P1.403 Summary Relative Bioavailability of Monomethyl Fumarate after Administration of ALKS 8700 and Dimethyl Fumarate in Healthy Subjects (P1.403).
Drugs in development
New MS medications can take years in development until they reach us. Find out about new drugs on the horizon for MS.
Drug development process
Find out about the different stages involved in making a new medicine.