Opportunity Information: Apply for PAR 19 146
Apply for PAR 19 146
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Drug Discovery For Nervous System Disorders (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.279, 93.866.
- This funding opportunity was created on 2019-01-08.
- Applicants must submit their applications by 2022-01-07. (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 $200,000.00 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.
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Opportunity Summary:
The NIH funding opportunity "Drug Discovery For Nervous System Disorders (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-19-146) is a discretionary grant program designed to push early-stage discovery and preclinical development of new small molecules or related compounds aimed at preventing or treating disorders of the nervous system. It is structured as an R21 exploratory/developmental award, meaning it is geared toward high-impact, innovative projects that are still at an earlier, risk-tolerant stage rather than fully mature development programs. As the title states, clinical trials are not allowed under this announcement, so the work must remain in discovery and preclinical spaces rather than testing interventions in human participants.
The main goal is to stimulate the creation and improvement of novel candidate therapeutics by supporting the practical steps that turn a biological insight into a credible drug-like compound. The FOA explicitly highlights several points along the discovery pipeline. First, it supports identification, design, synthesis, and preclinical testing of candidate therapeutic compounds, which can include finding hits through screening or rational design, making new chemical matter, and running early biological testing to see if the compounds engage the target and affect disease-relevant pathways. Second, it encourages initial hit-to-lead chemistry, where early hits are chemically modified to improve potency, selectivity, and basic drug-like properties against the intended target. Third, it supports later-stage lead optimization focused on improving efficacy and pharmacokinetics, which typically involves iterative medicinal chemistry informed by assay results and exposure data to produce a stronger, more developable lead series. Fourth, it allows and encourages initial drug metabolism and pharmacokinetics (DMPK) work, such as early ADME studies and preliminary in vivo PK, to identify liabilities (for example rapid clearance, poor bioavailability, or metabolic instability) and guide optimization.
A key theme is novelty in approach: the NIH emphasizes projects that bring new strategies for identifying potential therapeutic agents rather than incremental work on well-trodden paths. In practice, that can mean innovative screening paradigms, new target engagement or phenotypic assay systems, fresh chemical scaffolds, or creative ways to overcome common nervous system drug discovery barriers like blood-brain barrier penetration, CNS selectivity, toxicity risks, or translation from cellular models to relevant in vivo systems. While the announcement is about compound discovery for nervous system disorders broadly, the unifying requirement is that the proposed work should credibly advance a compound (or compound series) toward becoming a therapeutic candidate using solid preclinical evidence and a clear development logic.
Eligibility is broad and includes many types of organizations capable of carrying out drug discovery research. Eligible applicants include state, county, and local governments; special districts; 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; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicants 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth signals an intent to attract a wide range of research teams, from academic medicinal chemistry groups and translational neuroscience labs to nonprofit and industry-aligned discovery efforts, including international collaborators where appropriate.
From an administrative standpoint, the opportunity is issued by the National Institutes of Health, uses the grant funding instrument, and sits within the education and health funding activity categories. The associated CFDA numbers listed are 93.242, 93.279, and 93.866. The source information indicates an award ceiling of $200,000, with an original closing date of 2022-01-07 and a creation date of 2019-01-08. Overall, the announcement is best read as NIH support for innovative, preclinical, compound-centered research that can generate convincing leads for nervous system therapeutics, while stopping short of any clinical trial activity.
Frequently Asked Questions (FAQs)
What is the name and funding opportunity number for this NIH program?
The opportunity is titled "Drug Discovery For Nervous System Disorders (R21 Clinical Trial Not Allowed)" and the Funding Opportunity Number is PAR-19-146.
What type of award is this, and what does "R21" imply?
This is an R21 exploratory/developmental award. Based on the description provided, it is intended for high-impact, innovative projects that are still in an early, risk-tolerant stage of development rather than fully mature therapeutic development programs.
Are clinical trials allowed under this funding opportunity?
No. As stated in the title, clinical trials are not allowed under this announcement. The work must remain in discovery and preclinical spaces and should not involve testing interventions in human participants.
What is the main purpose of this grant program?
The main goal is to push early-stage discovery and preclinical development of new small molecules or related compounds aimed at preventing or treating disorders of the nervous system. It is meant to support practical steps that turn a biological insight into a credible drug-like compound.
What kinds of therapeutic modalities are emphasized?
The opportunity emphasizes new small molecules or related compounds intended to prevent or treat nervous system disorders.
What parts of the drug discovery pipeline does the FOA support?
The FOA highlights multiple points along the discovery pipeline, including:
- Identification, design, synthesis, and preclinical testing of candidate therapeutic compounds
- Hit discovery approaches such as screening or rational design
- Initial hit-to-lead chemistry to improve potency, selectivity, and basic drug-like properties
- Lead optimization to improve efficacy and pharmacokinetics through iterative medicinal chemistry
- Initial DMPK work, including early ADME studies and preliminary in vivo PK
Does the FOA support early screening and hit identification work?
Yes. The FOA supports finding hits through screening or rational design, creation of new chemical matter, and early biological testing to assess target engagement and effects on disease-relevant pathways.
What is meant by "hit-to-lead" under this announcement?
"Hit-to-lead" is described as the stage where early hits are chemically modified to improve potency, selectivity, and basic drug-like properties against the intended target.
What is meant by "lead optimization" in this context?
Lead optimization refers to a later stage where the project focuses on improving efficacy and pharmacokinetics, typically through iterative medicinal chemistry guided by assay results and exposure data to produce a stronger, more developable lead series.
Is DMPK (drug metabolism and pharmacokinetics) work allowed?
Yes. The FOA allows and encourages initial DMPK work, including early ADME studies and preliminary in vivo PK to identify liabilities such as rapid clearance, poor bioavailability, or metabolic instability and to guide compound optimization.
What kinds of preclinical testing are contemplated?
The description references early biological testing (such as target engagement and pathway impact), along with preclinical testing that supports advancing a compound or series toward a therapeutic candidate. It also specifically mentions early ADME and preliminary in vivo pharmacokinetics as examples of allowable preclinical work.
What does NIH mean by emphasizing "novelty in approach"?
A key theme is support for projects that bring new strategies for identifying potential therapeutic agents rather than incremental work on well-trodden paths. Examples mentioned include:
- Innovative screening paradigms
- New target engagement or phenotypic assay systems
- Fresh chemical scaffolds
- Creative ways to address common nervous system drug discovery barriers (for example blood-brain barrier penetration, CNS selectivity, toxicity risks, or translation from cellular models to relevant in vivo systems)
Is this opportunity limited to a specific nervous system disorder?
No specific disorder is singled out in the provided information. The announcement is described as applying to nervous system disorders broadly, with a unifying requirement that the proposed work should credibly advance a compound (or compound series) toward a therapeutic candidate using solid preclinical evidence and a clear development logic.
What is the unifying requirement for proposed projects?
The unifying requirement is that the work should credibly advance a compound or compound series toward becoming a therapeutic candidate, supported by solid preclinical evidence and a clear development logic, while remaining non-clinical.
Who is eligible to apply?
Eligibility is described as broad. Eligible applicants include:
- State, county, and local governments
- Special districts
- 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
- Public housing authorities/Indian housing authorities
- Nonprofits with and without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA explicitly calls out eligibility for several 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), and Tribally Controlled Colleges and Universities (TCCUs).
Can faith-based or community-based organizations apply?
Yes. The FOA explicitly includes faith-based or community-based organizations among the additional eligible applicants listed.
Are non-U.S. entities eligible to apply?
Yes. The FOA explicitly lists non-U.S. entities (foreign organizations) as eligible applicants.
Are U.S. territories or possessions included in eligibility?
Yes. The FOA explicitly includes U.S. territories or possessions among eligible applicants.
Which federal agency issues this opportunity?
This opportunity is issued by the National Institutes of Health (NIH).
What funding instrument is used?
The opportunity uses the grant funding instrument.
Which funding activity categories does it fall under?
The opportunity is listed under the education and health funding activity categories.
What CFDA numbers are associated with this opportunity?
The associated CFDA numbers listed are 93.242, 93.279, and 93.866.
What is the award ceiling listed for this opportunity?
The source information indicates an award ceiling of $200,000.
What are the key dates mentioned?
The information provided lists an original closing date of 2022-01-07 and a creation date of 2019-01-08.
How should applicants think about the scope of work given the "clinical trial not allowed" restriction?
Based on the description, applicants should plan work that stays in discovery and preclinical development, such as compound identification/design/synthesis, preclinical biological testing, hit-to-lead and lead optimization, and initial ADME/PK studies, without proposing testing of interventions in human participants.
What kinds of challenges in nervous system drug discovery does NIH appear interested in addressing?
The FOA highlights interest in creative approaches to overcome common barriers such as blood-brain barrier penetration, CNS selectivity, toxicity risks, and translation from cellular models to relevant in vivo systems.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 19 146) also looked into and applied for these:
| Funding Opportunity |
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| Bioengineering Research Grants (BRG) (R01 Clinical Trial Required) Apply for PAR 19 159 Funding Number: PAR 19 159 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R21 Clinical Trial Optional) Apply for PAR 19 153 Funding Number: PAR 19 153 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Optional) Apply for PAR 19 150 Funding Number: PAR 19 150 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Not Allowed) Apply for PAR 19 149 Funding Number: PAR 19 149 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Accelerating the Pace of Child Health Research Using Existing Data from the Adolescent Brain Cognitive Development (ABCD) Study (R01-Clinical Trial Not Allowed) Apply for PAR 19 162 Funding Number: PAR 19 162 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Mobile Technologies Extending Reach of Primary Care for Substance-Use-Disorders (R41/R42 Clinical Trial Optional) Apply for RFA DA 19 022 Funding Number: RFA DA 19 022 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Mobile Technologies Extending Reach of Primary Care for Substance-Use-Disorders (R43/R44 Clinical Trial Optional) Apply for RFA DA 19 021 Funding Number: RFA DA 19 021 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The Experimental Therapeutics Clinical Trials Network (UM1 Clinical Trials Required) Apply for RFA CA 19 007 Funding Number: RFA CA 19 007 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,250,000 |
| Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R43/R44 - Clinical Trial Optional) Apply for RFA DA 19 033 Funding Number: RFA DA 19 033 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratories (U24 Clinical Trials Not Allowed) Apply for RFA CA 19 008 Funding Number: RFA CA 19 008 Agency: National Institutes of Health Category: Education, Health Funding Amount: $320,000 |
| Improving Outcomes for Pediatric, Adolescent and Young Adult Cancer Survivors (U01 Clinical Trial Required) Apply for RFA CA 19 033 Funding Number: RFA CA 19 033 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R41/R42 - Clinical Trial Optional) Apply for RFA DA 19 032 Funding Number: RFA DA 19 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Provocative Questions (PQs) in Cancer with an Underlying HIV Infection (R01 Clinical Trial Optional) Apply for RFA CA 19 032 Funding Number: RFA CA 19 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HIV/AIDS Adult Therapeutics Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required) Apply for RFA AI 19 003 Funding Number: RFA AI 19 003 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Biology of Bladder Cancer (R21 Clinical Trial Optional) Apply for PAR 19 169 Funding Number: PAR 19 169 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Biology of Bladder Cancer (R01 Clinical Trial Optional) Apply for PAR 19 168 Funding Number: PAR 19 168 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Administrative Supplements to NCI Grant and Cooperative Agreement Awards to Support Collaborations with the PDX Development and Trial Centers Research Network (PDXNet) (Admin Supp Clinical Trial Not Allowed) Apply for PA 19 174 Funding Number: PA 19 174 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Awardee Skills Development Consortium: Research Education Short Courses (UE5 Clinical Trial Not Allowed) Apply for RFA CA 19 010 Funding Number: RFA CA 19 010 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Awardee Skills Development Consortium: Program Logistics and Evaluation Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA CA 19 011 Funding Number: RFA CA 19 011 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Biology of Bladder Cancer (R21 Clinical Trial Optional) Apply for PAR 19 184 Funding Number: PAR 19 184 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
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