Summary: The fiscal year 2026 (FY26) Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of multiple sclerosis. All applications must address at least one of the FY26 MSRP CTA focus areas. Clinical trials may evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance and/or emerging approaches and technologies.

Distinctive Features: The FY26 CTA offers two funding levels. The following are generalized descriptions of the scope of research appropriate for each funding level:

• Funding Level 1 (CTA-FL1) supports small-scale, proof-of-principle clinical trials (e.g., pilot, first-in-human, phase 0) to demonstrate feasibility or inform the design of more advanced trials, or other clinical trials that are appropriate for this funding level. Preliminary data relevant to the proposed clinical trial are required.

• Funding Level 2 (CTA-FL2) supports larger-scale clinical trials at phase 1 or phase 2 that seek to show preliminary evidence of safety or efficacy (i.e., benefit of clinical or paraclinical outcomes) in relevant patient populations. Clear description and justification should be provided, which could include, but is not limited to, the intervention type, trial duration, sample size, outcome measures, assessment tools and frequency of assessment. Preliminary data relevant to the proposed clinical trial in MS populations are required.

For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.

Miscellaneous

• Unrestricted