This National Institute on Drug Abuse (NIDA) grant aims to accelerate medication development for Substance Use Disorders (SUDs). It seeks high-impact preclinical and/or clinical research projects designed to quickly advance new medications toward FDA approval. Structured as a U01 cooperative agreement, this short-term grant offers significant financial support—up to $5 million annually for up to three years—with close NIDA staff involvement. This opportunity is specifically designed to enable critical medication development studies not feasible through traditional R01 mechanisms, ensuring rapid progress in SUD treatment.
Opportunity ID: 357987
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-328 |
| Funding Opportunity Title: | Grand Opportunity in Medications Development for Substance-Use Disorders (U01 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 2 |
| Posted Date: | Jan 03, 2025 |
| Last Updated Date: | Mar 31, 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: | $5,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Independent school districts Special district governments Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments City or township governments |
| 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 accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a broad array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-328.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 |
|---|---|---|
| Description updated | Mar 31, 2025 | |
| Jan 03, 2025 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-328 |
| Funding Opportunity Title: | Grand Opportunity in Medications Development for Substance-Use Disorders (U01 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 2 |
| Posted Date: | Jan 03, 2025 |
| Last Updated Date: | Mar 31, 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: | $5,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Independent school districts Special district governments Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments City or township governments |
| 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 accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a broad array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-328.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-328 |
| Funding Opportunity Title: | Grand Opportunity in Medications Development for Substance-Use Disorders (U01 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: | – |
| Current Closing Date for Applications: | Aug 11, 2025 |
| Archive Date: | Sep 16, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $5,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Private institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses |
| 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 accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-328.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 |
Related Documents
Folder 357987 Full Announcement-PAR-25-328 -> PAR-25-328-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 | PKG00289874 | Mar 10, 2025 | Aug 11, 2025 | View |
Package 1
Mandatory forms
357987 RR_SF424_5_0-5.0.pdf
357987 PHS398_CoverPageSupplement_5_0-5.0.pdf
357987 RR_OtherProjectInfo_1_4-1.4.pdf
357987 PerformanceSite_4_0-4.0.pdf
357987 RR_KeyPersonExpanded_4_0-4.0.pdf
357987 PHS398_ResearchPlan_5_0-5.0.pdf
357987 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357987 RR_Budget_3_0-3.0.pdf
357987 RR_SubawardBudget30_3_0-3.0.pdf
357987 PHS398_ModularBudget_1_2-1.2.pdf
357987 PHS_AssignmentRequestForm_4_0-4.0.pdf
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