Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional) | PAR 18 511

Opportunity Information: Apply for PAR 18 511

This NIH grant opportunity, titled "Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional)," supports research aimed at improving how pregnancy-related conditions are prevented and treated. The central goal is to push the field beyond describing symptoms or risk factors and toward pinpointing specific molecular targets that drive disorders that arise during pregnancy or are triggered by pregnancy. By identifying those targets, applicants are expected to lay the groundwork for developing medications that are both safer for pregnant people and more effective than current options, recognizing that pregnancy presents unique biological constraints and safety considerations that often limit drug choices.

The award mechanism is an NIH R01, which generally funds substantial, hypothesis-driven projects that can support multi-year research programs. The "Clinical Trial Optional" designation signals that applicants may propose studies that include a clinical trial if it is scientifically justified, but a clinical trial is not required. In practice, this means proposals could range from basic and translational work (such as target discovery, pathway mapping, validation in relevant model systems, and early therapeutic development) to later-stage efforts that may include human testing, provided the proposed approach aligns with NIH rules for clinical research and safety oversight.

The scientific emphasis is on pregnancy associated or pregnancy induced disorders, with a clear expectation that projects will do more than observe correlations. Competitive applications would typically be built around identifying actionable molecular pathways or targets, demonstrating that modulating those targets could plausibly prevent disease onset, reduce severity, or treat established disease during pregnancy, and showing a credible strategy for moving toward therapeutic development. While the notice does not list specific diseases in the excerpt, the theme is broad and would reasonably encompass conditions where pregnancy physiology plays a causal role or creates distinctive therapeutic needs, especially where existing treatments are inadequate or carry fetal or maternal risk.

Eligibility is broad and includes many types of U.S.-based organizations and governmental units. Eligible applicants include state, county, and municipal governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where relevant); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant categories, including 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, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign participation is restricted in a nuanced way. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant can include certain types of substantive foreign involvement (for example, specialized expertise, resources, or study populations abroad) if it meets NIH definitions and is appropriately justified and approved under NIH policy.

Administratively, the opportunity is issued by the National Institutes of Health and is categorized as a discretionary grant in the Health, Income Security and Social Services activity area, with CFDA number 93.865. The funding opportunity number is PAR-18-511, and the record shows a creation date of December 19, 2017. The excerpt lists an original closing date of January 7, 2021; applicants would typically need to confirm whether the FOA has been reissued, extended, or replaced, since NIH announcements often have multiple receipt dates over time or are superseded by newer versions.

Overall, the program is designed to fill a long-standing gap in pregnancy therapeutics by funding rigorous research that connects mechanistic molecular insights to practical therapeutic development, with the explicit aim of generating safer, pregnancy-appropriate interventions for disorders that arise during or are triggered by pregnancy.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2017-12-19.
• Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 18 511

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: