BG-12
BG-12 is an experimental new drug treatment for people with relapsing remitting multiple sclerosis (MS) that is taken orally (by mouth).
Other names: BG00012, dimethyl fumarate, fumarate, Panaclar
In development for: Relapsing remitting MS
Status: Phase III
Last updated: July 2009
How does it work?
The mechanism of action is not fully understood, but preclinical studies have suggested that BG-12 may have complex neuroprotective and anti-inflammatory effects.
How is it given?
BG-12 is taken orally as tablets, two or three times per day.
Clinical studies
In a phase II study, different doses of BG-12 were compared to placebo in people with relapsing remitting MS over 24 weeks of treatment. BG-12 significantly reduced MRI-detectable brain lesion activity. A 32% reduction in relapse rate was also observed but could not be considered significant since this measure was not included in the study design.
Further clinical trials
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DEFINE - Efficacy and safety of oral BG00012 in relapsing-remitting multiple sclerosis
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CONFIRM - Efficacy and safety study of oral BG00012 with active reference in relapsing-remitting multiple sclerosis
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Long-term safety and efficacy study of oral BG00012 monotherapy in relapsing-remitting multiple sclerosis
A phase III, 2 year study comparing two doses of BG-12 and placebo in 1011 participants with relapsing remitting MS. Main measure of the study is relapse rate. The study will also assess the effects of BG-12 on disability progression and disease activity as measured by magnetic resonance imaging (MRI). Further details of this study.
This phase III study with 1232 participants is similar to DEFINE, but with an additional group who will be taking glatiramer acetate (Copaxone) for comparison. Further details of this study.
An extension study for participants on the DEFINE and CONFIRM studies to assess the long-term effectiveness and safety of BG-12 for a further two years.. Further details of this study.
Side effects and contraindications
The most common side effects were abdominal pain and flushing/feeling hot.
References
Kappos L, et al.
Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study
Lancet 2008;372:1463-1472.
Read abstract

