Drug Discovery For Nervous System Disorders (R01 Clinical Trials Not Allowed) | PAR 19 147

FAQs: Drug Discovery for Nervous System Disorders (PAR-19-147)

What is PAR-19-147?

PAR-19-147, titled "Drug Discovery for Nervous System Disorders," is an NIH funding opportunity using the R01 grant mechanism. It supports early-stage therapeutic discovery and preclinical development activities for nervous system disorders, with the goal of advancing credible, well-characterized candidate compounds prior to any human testing.

Which NIH institutes support this funding opportunity?

The opportunity is backed by the National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA).

What is the main goal of the program?

The program is designed to push preclinical drug discovery forward by helping applicants identify, optimize, and validate small molecules or other novel compounds with potential to prevent or treat neurological or neuropsychiatric conditions.

Is this opportunity focused on clinical research or preclinical research?

It is centered on preclinical drug discovery and development. The expected work stays in discovery, optimization, and preclinical validation rather than patient-facing studies.

Are clinical trials allowed under PAR-19-147?

No. Clinical trials are explicitly not allowed under this announcement.

What types of disorders or conditions are relevant to this FOA?

The FOA targets nervous system disorders broadly, including neurological and neuropsychiatric conditions, aligned with the interests of NIMH and NIA.

What stages of drug discovery does this FOA support?

The scope covers key steps from an initial therapeutic idea to a viable preclinical drug candidate. This includes identifying therapeutic targets, finding or creating compounds that interact with those targets, improving early hits into leads, and optimizing leads using preclinical evidence and developability-focused data.

Can applicants propose therapeutic target identification work?

Yes. Projects may include identifying therapeutic targets and finding or creating compounds that interact with those targets.

What kinds of compounds are in scope?

The FOA supports small molecules and also allows for "other novel compounds" aimed at preventing or treating nervous system disorders, as long as they can be credibly characterized and advanced through preclinical discovery and optimization.

Does the FOA support screening and hit discovery?

Yes. The program supports identifying compounds, including early "hits" that may come from screening or rational design, followed by iterative improvement.

What is "hit-to-lead chemistry" and is it supported?

Hit-to-lead chemistry refers to taking early hits and modifying them to improve properties like potency, selectivity, and overall activity against a biological target. This is a major emphasis area within the FOA.

Does the FOA support lead optimization?

Yes. Later-stage lead optimization is within scope, including refining lead compounds to improve characteristics important for real-world drug performance.

What types of properties are emphasized during lead optimization?

The FOA highlights improvements related to efficacy in disease-relevant models, exposure levels, stability, and pharmacokinetics, among other performance-related characteristics.

Is early DMPK work supported?

Yes. The opportunity specifically highlights the importance of early drug metabolism and pharmacokinetics (DMPK), including studies of absorption, distribution, metabolism, and clearance, and whether a compound has characteristics consistent with eventual development.

What outputs or deliverables are expected from funded projects?

The FOA expects actionable outputs such as optimized lead series, clear structure-activity relationships (SAR), evidence of target engagement and functional impact, and early pharmacology and DMPK data that position a candidate for future preclinical development steps beyond the award.

What does the FOA mean by prioritizing "novelty"?

While traditional medicinal chemistry and screening strategies are allowed, the FOA explicitly prioritizes projects that bring new or creative methods to identifying or generating potential therapeutic agents. Applicants are expected to make a convincing case that their strategy, platform, screening paradigm, target engagement approach, or optimization workflow is meaningfully innovative compared with standard pipelines.

Are traditional medicinal chemistry approaches allowed?

Yes. Traditional medicinal chemistry and screening approaches are within scope, though the FOA places particular emphasis on innovative or creative approaches.

What funding mechanism is used for this opportunity?

This is a discretionary NIH grant program using the R01 mechanism.

What funding activity areas are associated with this FOA?

The opportunity is categorized under education and health-related funding activity areas.

What CFDA numbers are associated with PAR-19-147?

The associated CFDA numbers listed are 93.242, 93.279, and 93.866.

What were the dates listed for the FOA record?

The source record indicates the FOA was created on January 8, 2019, and shows an original closing date of January 7, 2022.

Are the listed dates current?

The dates provided should be treated as historical. Applicants are expected to verify whether there are current re-issues or successor announcements if pursuing a similar application now.

Who is eligible to apply?

Eligibility is broad and includes many organizational types. Eligible applicants include federal, state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; public housing and Indian housing authorities; and Native American tribal governments (federally recognized) and certain tribal organizations beyond federally recognized governments.

Are minority-serving institutions explicitly included?

Yes. The FOA explicitly notes additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, and TCCUs.

Can faith-based or community-based organizations apply?

Yes. Faith-based or community-based organizations are listed among the eligible applicant categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicant categories.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The FOA includes non-U.S. entities (foreign organizations) among eligible applicants.

What kinds of teams are best suited for this FOA?

This opportunity is best suited to teams that can combine strong disease biology and target rationale with medicinal chemistry, screening, pharmacology, and early DMPK capabilities, and that can present a clear, data-driven plan to progress from initial compounds to optimized leads without entering clinical trial work.

What kind of project would be out of scope based on the information provided?

Any project involving clinical trials or human testing would be out of scope, since clinical trials are explicitly not allowed and the FOA focus is preclinical discovery and optimization.