Opportunity Information: Apply for PAR 18 427
The grant opportunity "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required)" is a National Institutes of Health (NIH) cooperative agreement aimed at accelerating early clinical testing of new treatments for psychiatric disorders, especially where current options are limited or inadequate. It focuses on gathering strong, decision-quality human data as quickly as possible so that promising approaches can be advanced into later-stage development, and weak or non-viable approaches can be stopped early. In practical terms, the program is designed to "de-risk" novel drug and device candidates by producing the kinds of results that make it easier to attract follow-on private investment and support eventual FDA approval pathways.
The FOA supports milestone-driven early stage clinical trials in both pediatric and adult populations. For drug candidates, the announcement emphasizes first-in-human (FIH) and Phase Ib studies for agents with novel mechanisms of action. These early studies are expected to do more than basic safety screening: they must assess whether the drug is actually engaging its intended biological target, including evidence relevant to brain exposure when appropriate, and demonstrate measurable pharmacological effects. Alongside target engagement, the studies must carefully evaluate safety and tolerability, with the explicit purpose of deciding whether the candidate is feasible to move forward into Phase II or proof-of-concept (PoC) trials in psychiatric indications.
For Phase II/PoC work, the FOA sets expectations that go beyond symptom checklists alone. Supported studies must evaluate the drug's impact on clinically relevant physiological systems using functional measures, and they must also examine clinical indicators of effect. The intention is to link mechanism to meaningful outcomes: showing that a candidate not only reaches and affects the brain or target pathway, but also produces measurable changes in biological or functional domains that matter for psychiatric illness, while providing early signals of clinical benefit.
The announcement also explicitly includes novel devices and combination approaches. For devices, it supports first-in-human and early feasibility studies (EFS), with required evaluation of target engagement (for example, evidence that a neuromodulation device is affecting the intended circuit or biomarker), safety, tolerability, and efficacy. The device language mirrors the drug emphasis on rapid, rigorous early testing that can support clear go/no-go decisions and position a technology for the next stages of development.
A central feature of this FOA is its emphasis on collaborative partnerships between academic or biomedical researchers and biotechnology or industry partners. The cooperative agreement structure (U01) signals substantial NIH involvement and oversight compared to a standard research grant, and the partnership requirement reflects the program's translational goal: to move candidates toward real-world development, regulatory readiness, and eventual commercialization or broader clinical adoption. The overall thrust is not basic discovery, but structured early clinical evaluation that produces actionable evidence for development decisions.
In terms of eligibility, the opportunity is broadly open across many U.S.-based organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); and for-profit organizations (including small businesses, and other than small businesses). It also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and U.S. territories or possessions. At the same time, it clearly restricts foreign participation: non-U.S. entities and non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
Administratively, the FOA is listed as PAR-18-427 under NIH, within the health funding activity category and CFDA number 93.242, and uses the cooperative agreement funding instrument type. The original closing date provided in the source information is February 18, 2021, and while the listing includes fields such as award ceiling and expected awards, those specific values are not provided in the text you shared. Overall, the program is best understood as a translational, milestone-based NIH effort to move high-potential psychiatric drugs and devices through the earliest clinical stages with strong mechanistic and functional evidence, positioning successful candidates for Phase II/III development and eventual regulatory pathways.Apply for PAR 18 427
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (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): 93.242.
- This funding opportunity was created on 2017-12-06.
- Applicants must submit their applications by 2021-02-18. (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.
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01-Clinical Trial Required)."
Which agency is offering this funding?
This is a National Institutes of Health (NIH) funding opportunity.
What is the FOA number?
The FOA is listed as PAR-18-427.
What type of funding instrument is this?
The funding instrument is a cooperative agreement (U01), which typically involves substantial NIH involvement and oversight compared to a standard research grant.
What is the main purpose of this program?
The program is designed to accelerate early clinical testing of novel investigational drugs and devices for psychiatric disorders and to generate strong, decision-quality human data quickly. The intent is to support clear development decisions: advance promising candidates into later-stage development and stop weak or non-viable approaches early.
What does it mean that the program aims to "de-risk" candidates?
In this context, "de-risk" means producing rigorous early human evidence (for example, target engagement, pharmacological effects, safety/tolerability, and early efficacy signals) that can support go/no-go decisions, help attract follow-on private investment, and position a candidate for future FDA approval pathways.
Is this opportunity focused on basic research or translational development?
Based on the description provided, the overall thrust is translational development: structured early clinical evaluation that produces actionable evidence for development decisions, rather than basic discovery research.
What kinds of studies does this FOA support?
The FOA supports milestone-driven early stage clinical trials, including first-in-human and early studies for both drug and device candidates. It also supports Phase II/proof-of-concept (PoC) expectations as described in the provided text.
Are clinical trials required under this FOA?
Yes. The title explicitly states "Clinical Trial Required," and the program description focuses on conducting early clinical testing in humans.
Does the FOA support studies in both adults and children?
Yes. The FOA supports milestone-driven early stage clinical trials in both pediatric and adult populations.
What stages of drug development are emphasized?
For drug candidates, the FOA emphasizes first-in-human (FIH) and Phase Ib studies, particularly for agents with novel mechanisms of action.
What does the FOA expect from early drug studies besides basic safety?
Early drug studies are expected to go beyond basic safety screening. They must assess whether the drug is engaging its intended biological target (including evidence relevant to brain exposure when appropriate) and demonstrate measurable pharmacological effects, alongside careful safety and tolerability evaluation.
What is "target engagement" in the context of this FOA?
Target engagement refers to evidence that the investigational drug or device is affecting the intended biological target or pathway. For drugs, this includes evidence relevant to engaging the intended target and, when appropriate, information relevant to brain exposure. For devices, it can include evidence that a neuromodulation device is affecting the intended circuit or biomarker.
What is the intended decision point after FIH/Phase Ib drug studies?
The stated purpose is to determine whether the candidate is feasible to move forward into Phase II or proof-of-concept trials in psychiatric indications.
What does the FOA expect from Phase II/proof-of-concept (PoC) studies?
The FOA sets expectations beyond symptom checklists alone. Supported studies must evaluate impact on clinically relevant physiological systems using functional measures and examine clinical indicators of effect, with the intention of linking mechanism to meaningful outcomes.
Does the FOA support devices as well as drugs?
Yes. The announcement explicitly includes novel devices, as well as combination approaches.
What kinds of device studies are supported?
For devices, the FOA supports first-in-human and early feasibility studies (EFS), with required evaluation of target engagement, safety, tolerability, and efficacy.
How does the FOA approach go/no-go decisions?
A core aim is rapid, rigorous early testing that supports clear go/no-go decisions. The program is structured to advance approaches with strong early evidence and to stop approaches that are weak or non-viable based on decision-quality human data.
Are combination approaches allowed?
Yes. The announcement explicitly includes combination approaches in addition to drugs and devices.
Is an academic-industry partnership expected?
Yes. A central feature is an emphasis on collaborative partnerships between academic or biomedical researchers and biotechnology or industry partners, aligning with the program's translational and development-focused goals.
Why does the FOA emphasize partnerships?
As described, the partnership requirement reflects the goal of moving candidates toward real-world development, regulatory readiness, and eventual commercialization or broader clinical adoption.
Who is eligible to apply?
Eligibility is broadly open across many U.S.-based organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); and for-profit organizations (including small businesses and other than small businesses).
Are minority-serving institutions and similar organizations eligible?
Yes. The FOA highlights additional eligible applicant categories including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are faith-based and community-based organizations eligible?
Yes. Faith-based or community-based organizations are included among the highlighted eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly mentioned among eligible applicant categories.
Are foreign organizations or foreign components allowed?
No. The opportunity restricts foreign participation: non-U.S. entities and non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.242.
What is the funding activity category?
The listing indicates the health funding activity category.
What is the stated closing date?
The original closing date provided in the source information is February 18, 2021.
Are the award ceiling and number of expected awards provided?
No. While those fields are referenced in the listing, the specific values are not provided in the information shared.
What kinds of outcomes is the FOA trying to produce?
The FOA aims to generate actionable evidence that links mechanism to outcomes, such as target engagement and measurable pharmacological or functional effects, along with safety/tolerability and early signals of clinical benefit. The goal is to position successful candidates for later-stage development and regulatory pathways.
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