Relapsing Multiple Sclerosis (RMS)
Neurology
5
Pipeline Programs
2
Companies
4
Clinical Trials
1
Approved Products
Pipeline by Development Stage
Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
0
0
3
1
Early DiscoveryClinical DevelopmentMarket
Drug Modality Breakdown
Monoclonal Antibody
3100%
+ 1 programs with unclassified modality
On Market (1)
Approved therapies currently available
U
BRIUMVIApproved
ublituximab
Unknown CompanyCD20-directed Cytolytic Antibody [EPC]intravenous2022
Competitive Landscape
2 companies ranked by most advanced pipeline stage
TG TherapeuticsNEW YORK, NY
3 programs3
UblituximabPhase 3Monoclonal Antibody1 trial
UblituximabPhase 3Monoclonal Antibody1 trial
UblituximabPhase 3Monoclonal Antibody1 trial
Active Trials
Trial Timeline
Clinical trial activity over time
2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
TG TherapeuticsUblituximab
TG TherapeuticsUblituximab
TG TherapeuticsUblituximab
Cabaletta BioCABA-201
Clinical Trials (4)
Total enrollment: 2,206 patients across 4 trials
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Start: Nov 2019Est. completion: May 20321,100 patients
Phase 3Active Not Recruiting
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Start: Sep 2017Est. completion: Nov 2020549 patients
Phase 3Completed
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Start: Aug 2017Est. completion: Nov 2020545 patients
Phase 3Completed
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
Start: Jun 2026Est. completion: Oct 202912 patients
Phase 1/2Not Yet Recruiting
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Phase Legend
Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available
Key Insights
3 late-stage (Phase 3) programs — potential near-term approvals
Monoclonal Antibody is the dominant modality (100% of programs)
2 companies competing in this space