Limited Competition for NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (UH3) | Apply Online

Opportunity Summary:

The Limited Competition for NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (UH3) (Funding Opportunity Number PAR-14-211) is an NIH cooperative agreement led by the National Center for Advancing Translational Sciences (NCATS) aimed at repurposing or redirecting existing proprietary drug candidates toward new disease indications. The core idea is to take drug candidates (referred to as "Agents") that have already been developed by pharmaceutical company partners and investigate whether those molecules could be effective in treating different human diseases than originally intended. Rather than starting from scratch with a brand-new compound, this program is designed to leverage prior industry investment and existing knowledge about the molecule to accelerate translational progress and reduce early development risk.

This opportunity specifically supports milestone-driven Phase 2a clinical trials under the UH3 mechanism. In practical terms, the program is looking for clinical studies that can show two things in the proposed patient population: first, that the Agent actually modulates its intended biological target in humans (a clear signal of target engagement or pathway modulation), and second, that this target modulation has a credible chance of translating into a meaningful clinical benefit for the disease being studied. Applications are expected to be grounded in strong scientific rationale. A competitive proposal does not just suggest that a drug might help; it supports the hypothesis with evidence that changing the activity of the drug target should plausibly improve the disease or condition, such as human genetics, prior clinical observations, compelling preclinical data, biomarker evidence, or well-supported mechanistic links between the target and disease biology.

A key feature of this program is that it is limited competition and uses a staged entry process. Investigators are not meant to jump straight into the UH3 application. Instead, the program begins with an X02 pre-application encouraged under a companion announcement (PAR-14-213). That X02 submission functions as the front door to the program and is reviewed by outside experts. Only the most meritorious pre-applications are invited to submit a full clinical trial application. Depending on the specific project and patient population, invited applicants may be directed to apply under this UH3 FOA (PAR-14-211) or under related companion FOAs that support a phased UH2/UH3 structure (for example, to include an earlier preparatory stage before Phase 2a). There is also a companion pathway noted for pediatric indications. The overall structure is intended to focus resources on the proposals with the strongest biological rationale, clearest clinical plan, and highest likelihood of producing an interpretable signal in a relatively early-stage human trial.

Because the award is a cooperative agreement, recipients should expect substantial programmatic involvement from NIH compared with a standard grant. Cooperative agreements typically come with more active scientific and operational collaboration, including close attention to prospectively defined milestones, go/no-go decision points, and progress monitoring. The emphasis on milestones is not cosmetic; the program is built around the idea that Phase 2a studies should answer specific translational questions efficiently, using measurable endpoints such as biomarkers, pharmacodynamic readouts, target engagement markers, and early clinical outcomes that can inform whether the Agent should move forward for the new indication.

From an eligibility standpoint, the announcement is broad and includes many types of organizations, reflecting the translational and clinical nature of the work. Eligible applicants include public and private institutions of higher education, nonprofits (including 501(c)(3) organizations and other nonprofits), for-profit organizations (including small businesses and for-profits other than small businesses), and a wide range of government entities (state, county, city/township, special districts, and certain housing authorities). The eligibility list also explicitly includes organizations such as HBCUs, Hispanic-serving institutions, tribal governments and tribally controlled colleges and universities, and Alaska Native and Native Hawaiian-serving institutions, among others. Foreign components, as defined in the NIH Grants Policy Statement, are allowed, which can matter for global clinical expertise, specialized patient populations, or unique clinical research infrastructure. The opportunity does not require cost sharing or matching.

In terms of timing and administrative details, the opportunity was posted on May 12, 2014, with an original and current closing date of January 16, 2015, and an archive date of February 16, 2015. It is categorized as a discretionary funding opportunity and falls under broad federal activity categories associated with education, health, and social services. Multiple CFDA numbers are listed, reflecting the cross-cutting nature of the program and its relevance to multiple NIH mission areas, including NCATS (93.350) and several disease-focused research programs (for example, mental health, addiction, neuroscience, aging, vision, child health, and others). That breadth is consistent with the program's intent: investigators can propose new uses for the industry-provided Agents across a wide range of human diseases rather than being confined to a single therapeutic area.

At a high level, the opportunity is best understood as a translational bridge between industry-held assets and academic or clinical investigator creativity. Investigators bring the disease-area insight, mechanistic hypothesis, and clinical trial design for a new indication, while pharmaceutical partners provide access to proprietary molecules that may be sufficiently advanced to justify Phase 2a testing. The program is structured to prioritize proposals that can convincingly connect target biology to disease mechanism, propose a feasible and well-controlled early clinical trial, and deliver decisive data about whether the molecule is engaging the biology and moving the needle clinically in the intended patient population.

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