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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) is sponsored by U.S. Food and Drug Administration (FDA). This funding opportunity aims to support clinical trials evaluating the efficacy and/or safety of products for new indications or labeling changes to address unmet needs in rare diseases or conditions.
The FDA expects this program to increase the number of approved treatments for rare diseases through collaborative, efficient, and innovative clinical trials.
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Search similar grants →Based on current listing details, eligibility includes: Eligibility includes Higher Education Institutions, Nonprofits, For-Profit Organizations, Local Governments, State Governments, Federal Governments, and Non-domestic (non-U.S.) Entities (Foreign Organizations). Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates Varies Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
The current target date is October 21, 2025. Build your timeline backwards from this date to cover registrations, approvals, attachments, and final submission checks.
Federal grant success rates typically range from 10-30%, varying by agency and program. Build a strong proposal with clear objectives, measurable outcomes, and a well-justified budget to improve your chances.
Requirements vary by sponsor, but typically include a project narrative, budget justification, organizational capability statement, and key personnel CVs. Check the official notice for the complete list of required attachments.
Yes — AI tools like Granted can help research funders, draft proposal sections, and check compliance. However, always review and customize AI-generated content to reflect your organization's unique strengths and the specific requirements of the solicitation.
Review timelines vary by funder. Federal agencies typically take 3-6 months from submission to award notification. Foundation grants may be faster, often 1-3 months. Check the program's timeline in the official solicitation for specific dates.
Many federal programs offer multi-year funding or allow competitive renewals. Check the official solicitation for continuation and renewal policies. Non-competing continuation applications are common for multi-year awards.
Past winners and funding trends for this program
Orphan Products Grants Program is sponsored by U.S. Food and Drug Administration (FDA). This program awards grants to clinical investigators to support the development of safe and effective medical products (drugs, biologics, medical devices, and foods for medical purposes) for patients with rare diseases or conditions, defined as those affecting fewer than 200,000 persons in the United States. Urea cycle disorders fall under this definition. The program funds clinical trials and natural history studies.
Minor Use Minor Species Development of Drugs (R01) (PAR-24-216) is sponsored by U.S. Food and Drug Administration (FDA) / National Institutes of Health (NIH). This grant supports the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species or to treat minor species. It covers routine safety, effectiveness, manufacturing, and toxicology studies.