The National Institute on Drug Abuse (NIDA) is offering this UG3/UH3 Cooperative Agreement grant to fast-track discovery and development of safe, effective medications for substance use disorders (SUDs) and overdose. This two-phase award supports projects with specific milestones: an initial 2-year UG3 phase, potentially transitioning to a 3-year UH3 phase upon successful completion. This grant is for preclinical or clinical research evaluating small molecules, biologics, or natural products. Studies may focus on new chemical entities, formulations, or combinations, addressing manifestations like withdrawal, craving, relapse, or overdose. The ultimate goal is to advance promising therapies towards FDA approval.
Opportunity ID: 357988
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-329 |
| Funding Opportunity Title: | Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.279 — Drug Use and Addiction Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 03, 2025 |
| Last Updated Date: | Jan 03, 2025 |
| Original Closing Date for Applications: | Aug 11, 2025 |
| Current Closing Date for Applications: | Aug 11, 2025 |
| Archive Date: | Sep 16, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Independent school districts For profit organizations other than small businesses Public and State controlled institutions of higher education Small businesses Special district governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice of Funding Opportunity (NOFO) is to support the discovery and development of medications to prevent and treat substance use disorders (SUDs) and overdose. The UG3/UH3 Phase Innovation Awards Cooperative Agreement involves 2 phases. The UG3 is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this NOFO must address both UG3 and UH3 phases. Application may include preclinical or clinical research studies that will have high impact and quickly yield the necessary results to advance closer to FDA approval medications that are safe and effective to prevent and treat SUDs and overdose. The compounds to be evaluated can be small molecules, biologics, or natural products. They can be tested in pre-clinical models and/or for the clinical manifestations of SUDs such as withdrawal, craving, relapse, or overdose. Applications may focus on the development of new chemical entities, new formulations of marketed medications available for other indications, or combinations of medications that hold promise for the treatment of SUDs and overdose. Through this NOFO, NIDA seeks to fast-track the discovery and development of medications to prevent and treat SUDs or overdose and to advance them in the FDA’s drug development approval pipeline. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-329.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357988 Full Announcement-PAR-25-329 -> PAR-25-329-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289875 | Mar 10, 2025 | Aug 11, 2025 | View |
Package 1
Mandatory forms
357988 RR_SF424_5_0-5.0.pdf
357988 PHS398_CoverPageSupplement_5_0-5.0.pdf
357988 RR_OtherProjectInfo_1_4-1.4.pdf
357988 PerformanceSite_4_0-4.0.pdf
357988 RR_KeyPersonExpanded_4_0-4.0.pdf
357988 RR_Budget10_3_0-3.0.pdf
357988 PHS398_ResearchPlan_5_0-5.0.pdf
357988 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357988 RR_SubawardBudget10_30_3_0-3.0.pdf
357988 PHS_AssignmentRequestForm_4_0-4.0.pdf
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