PAR-25-329: Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2025.
National Institutes of Health offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on August 11, 2025.
From the official notice on Grants.gov, last changed January 3, 2025. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeUG3 / UH3
- Clinical trialsOptional
- Funded byNIDA
- Median yearly award$2.8 million
- Typical project length2 years
- UG3, Exploratory/Developmental Phase I Cooperative Agreement. The first phase of a phased cooperative agreement. Moving on to the UH3 phase depends on meeting agreed milestones. Other open UG3 notices.
- UH3, Exploratory/Developmental Cooperative Agreement Phase II. The second phase of a phased cooperative agreement, usually following a UG3 or UH2 phase. Other open UH3 notices.
Projects funded under PAR-25-329 were run by National Institute on Drug Abuse (NIDA, 3 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read PAR-25-329 in the NIH Guide.
Key dates
| Posted | January 3, 2025 |
|---|---|
| Deadline | August 11, 2025 |
| Archived by Grants.gov | September 16, 2025 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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 (see text field entitled "Additional Information on Eligibility" for clarification)
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.
Is this a realistic fit?
- Most of the program's money (70% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
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.
Funded under PAR-25-329 so far
NIH funded 3 projects under PAR-25-329 in fiscal 2026, at 2 institutions. The median yearly award was $2.8 million.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| NTX-2001, a trace amine-associated receptor 1 (TAAR1) partial agonist, for the treatment of Cocaine Use Disorder | Newleos Therapeutics, Inc. | 2026 | $3.1 million |
| Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder | UT Southwestern Medical Center | 2026 | $2.8 million |
| Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression | UT Southwestern Medical Center | 2026 | $825,374 |
Who has won Drug Use and Addiction Research Programs grants before
From fiscal 2021 to 2025, Drug Use and Addiction Research Programs (93.279) awarded $7.3 billion across 5,071 grant awards, an average of $1.4 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Yale Univ | Connecticut | 150 | $305 million |
| The Johns Hopkins University | Maryland | 156 | $262 million |
| University of California, San Diego | California | 120 | $242 million |
| University of Pittsburgh - of the Commonwealth System of Higher Education | Pennsylvania | 100 | $182 million |
| New York University | New York | 62 | $173 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is PAR-25-329 still open?
No. It closed on August 11, 2025.
Who can apply for Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)?
National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)?
Closed August 11, 2025. Applications are no longer accepted; the program's newer notices are on this page when there are any.
Who has been funded under PAR-25-329?
NIH RePORTER lists 3 projects funded under PAR-25-329 in fiscal 2026, at 2 institutions. The most were at UT Southwestern Medical Center, Newleos Therapeutics, Inc.
Who has won Drug Use and Addiction Research Programs grants before?
The largest recipients over five fiscal years were Yale Univ, The Johns Hopkins University, University of California, San Diego. The program made 5,071 awards worth $7.3 billion in that time.
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