Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required: 16% First-Time Win Rate

Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

Food and Drug Administration · HHS

Your odds: program 93.103

A realistic target for an established nonprofit. 16% of awards go to first-time applicants and nonprofits win 20%.

Based on 388 new awards in FY2023–25. The median award is $549,857. Expect about 70 days between posting and deadline.

First-time winners: 16%; of new 93.103 awards
Nonprofit share: 20%; of awards
Median award: $550K; FY2025
New awards, FY2025: 128; 388 in 3 years
Typical window: 70 d; usually posts Jan
Under-$1M orgs: n/a; of nonprofit awards

About this grant

The purpose is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.

Who can apply

For-profit organizationsSpecial district governmentsNonprofits without 501(c)(3) statusPrivate colleges & universitiesNative American tribal organizationsCity or township governmentsFederally recognized tribal governments501(c)(3) nonprofitsPublic & state-controlled collegesUnrestricted (open to anyone)State governmentsPublic & Indian housing authoritiesSmall businessesIndependent school districtsCounty governments

How to apply

Read the full announcement on Grants.gov before you start. Federal applications are submitted through Grants.gov (or the agency's own system) and require a Unique Entity ID from SAM.gov. Registration can take several weeks, so start early. Contact: Terrin Brown Grantor · terrin.brown@fda.hhs.gov · 2404027610

What are the odds for a first-time applicant?

A realistic target for an established nonprofit. 16% of awards go to first-time applicants and nonprofits win 20%. Based on 388 new awards in FY2023–25. The median award is $549,857. Expect about 70 days between posting and deadline.

Who can apply for Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required?

Eligible applicants: For-profit organizations; Special district governments; Nonprofits without 501(c)(3) status; Private colleges & universities; Native American tribal organizations; City or township governments; Federally recognized tribal governments; 501(c)(3) nonprofits; Public & state-controlled colleges; Unrestricted (open to anyone); State governments; Public & Indian housing authorities; Small businesses; Independent school districts; County governments.

When is the deadline?

The funder has forecast this opportunity but hasn't announced a deadline yet. Sign up for a reminder and we'll email you when it opens.

How much funding is available?

Individual awards: $650K – $900K.

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