BAFIERTAM (monomethyl fumarate)
BAFIERTAM is a treatment indicated for adults with relapsing forms of multiple sclerosis. The medication is used to manage specific disease presentations, including clinically isolated syndrome and relapsing-remitting disease. It is also approved for patients diagnosed with active secondary progressive disease.
How BAFIERTAM Works
The specific mechanism by which monomethyl fumarate exerts its therapeutic effect in multiple sclerosis is currently unknown. The drug has been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in how cells respond to oxidative stress. Additionally, the compound has been identified as a nicotinic acid receptor agonist in laboratory studies.
Details
- Status
- Prescription
- First Approved
- 2020-04-28
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
BAFIERTAM Approval History
What BAFIERTAM Treats
1 indicationsBAFIERTAM is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
BAFIERTAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BAFIERTAM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BAFIERTAM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BAFIERTAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04022473 | BLS-11-109 | Ph 1 | completed | Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BAFIERTAM FDA Label Details
Indications & Usage
FDA Label (PDF)BAFIERTAM is indicated for the treatment of Multiple Sclerosis.
BAFIERTAM Patents & Exclusivity
Patents (21 active)
Pro Intelligence Preview
Deep insights for BAFIERTAM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 21 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.