Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required) | PAR 18 910

Opportunity Information: Apply for PAR 18 910

The Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required) is a National Institutes of Health (NIH) funding opportunity designed to support clinical testing of new disease uses for existing experimental drugs or biologics, referred to as "Assets." Instead of developing a new compound from scratch, applicants are expected to take advantage of investigational molecules already developed by pharmaceutical company partners and propose a scientifically grounded new therapeutic indication. The program is meant to accelerate translation to the clinic by pairing promising academic or other research ideas with industry-held molecules, with the expectation that the proposed work includes a clinical trial.

This announcement is issued as a cooperative agreement (U01), which typically means NIH will have substantial involvement in the project beyond standard grant oversight. In practical terms, awardees should be prepared for an active partnership model where NIH may coordinate, advise, or collaborate on key elements of the study as it moves forward. The activity falls under the health category (CFDA 93.350), and it focuses on clinical evaluation, not just preclinical hypothesis generation. The emphasis is on testing new therapeutic uses across a broad range of human diseases and conditions, and it explicitly allows inclusion of both adult and pediatric populations, as appropriate for the proposed indication and trial design.

A competitive application is expected to make a strong scientific case that changing or modulating the Asset's biological target is likely to benefit the chosen disease or condition. That usually implies the proposal should be backed by convincing mechanistic rationale, prior evidence from human or animal biology, clinical observations, or other data that connect the target to disease pathways. The goal is not simply to run a trial because a molecule is available, but to pursue a well-justified repurposing concept where the underlying biology supports a reasonable chance of clinical impact.

Eligibility is broad and includes many common U.S.-based applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; small businesses and other for-profit entities (other than small businesses); and nonprofit organizations, including both 501(c)(3) and non-501(c)(3) nonprofits (excluding institutions of higher education when specified in those categories). It also includes federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and Native American tribal organizations that are not federally recognized tribal governments. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign-based elements of the research (for example, a collaborating site or performance component) if it meets NIH definitions and policy requirements. This structure keeps the applicant organization U.S.-based while still allowing justified international collaboration components when permitted.

Key administrative details included in the source information are that the opportunity number is PAR 18 910, the FOA was created on 2018-08-31, and the original closing date listed is 2021-05-03. The award ceiling is shown as $3,000,000. The announcement does not specify the number of expected awards in the provided excerpt, but the ceiling indicates the program can support relatively large, trial-oriented projects where clinical operations, regulatory needs, and coordination costs are significant.

Overall, this FOA supports investigator-proposed clinical trials that aim to find new therapeutic uses for existing investigational industry molecules, with NIH operating in a cooperative partner role. The strongest proposals are expected to combine a clear and compelling biological rationale with a feasible clinical trial plan that can meaningfully test whether the Asset can improve outcomes in the proposed disease or condition.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
• This funding opportunity was created on 2018-08-31.
• Applicants must submit their applications by 2021-05-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
• Eligible applicants include: 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, Others.

Apply for PAR 18 910

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