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

Source: https://welltoldgrants.com/grants/rfa-fd-25-001-clinical-trials-addressing-unmet-needs-of-rare/  
Official notice: https://www.grants.gov/search-results-detail/356170

> Food and Drug Administration offered grants of up to $650,000 to any type of organization. It expected to make $900,000 in total. Applications closed on October 21, 2025.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-25-001 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | October 21, 2025 |
| Award ceiling | $650,000 |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | $900,000 |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

## What the grant funds

The purpose of this Notice of Funding Opportunity (NOFO) 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.

## Questions people ask

### Is RFA-FD-25-001 still open?

No. It closed on October 21, 2025. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

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

Food and Drug Administration accepted applications from any type of organization.

### What is the deadline for Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required?

Closed October 21, 2025. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $650,000 each. About $900,000 in total.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.