Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for researchers developing non-addictive pain medications as part of the NIH HEAL Initiative. Academic institutions, nonprofit organizations, and other research entities with NIH funding capability may apply. The program funds early-stage drug discovery through Phase I development, excluding basic research and clinical studies beyond Phase I. Applicants should have expertise in pain biology, drug development, clinical testing, or related areas.
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Key dates
- Jun 16, 2026 Applications open
- Sep 24, 2026 Award announced
- Nov 26, 2026 Project start
- Feb 20, 2029 Application deadline in 950 days
Program description
Twelve NIH Institutes, including NINDS, NEI, NHLBI, NIA, NIAAA, NIAMS, NICHD, NIDCR, NIDDK, NIDA, NCCIH and NCI intend to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research focused on the discovery and development of small molecule and biologic non-addictive analgesic therapeutics to treat pain. This study is part of the NIH Helping to End Addiction Long -term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The goal of the program is to accelerate the optimization and development of promising early therapeutic molecules and to facilitate readiness for Phase II clinical studies. Through this NOFO, the NIH offers researchers funding for drug discovery and development activities that can be conducted in their own laboratories. Researchers also have the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in critical areas associated with therapeutics development. The scope of this program spans early optimization through Phase I development activities. It is expected that all projects will be entering first in human studies at the end of the grant period either through NIH contracts or funds requested in the grant application. This is a milestone-driven, phased, cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress. The scope of this program excludes basic research, therapeutic device development and clinical studies beyond Phase I studies. Applications are not being solicited at this time. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will use the UG3/UH3 activity code. Investigators with expertise and insights into pain therapeutics development are encouraged to consider applying for this revised NOFO. In addition, applications from collaborating investigators combining expertise in pain biology, drug development, clinical testing and statistical design will be encouraged to consider applying for this funding opportunity.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) form
- Project Narrative
- Detailed Budget and Budget Justification
- Biographical sketches of key personnel
- Letters of support from collaborators/CROs
- Facilities and resources description
- Data management and sharing plan
Program contact
- 👤 Mohamed Hachicha, PhD National Institute of Neurological Disorders and Stroke
- 📧 mohamed.hachicha@nih.gov
- 📞 301-496-1779
Funding track record
Recent awards under CFDA 93.395 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$353,109,533
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$226,323,195
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$180,463,644
-
$148,820,579
-
$143,093,026
-
$125,672,442
-
$124,513,663
-
$112,462,142
-
$109,067,856
-
$104,790,648
Top States by Funding
- CA 10 awards $871.7M
- PA 5 awards $513.3M
- NY 7 awards $462.6M
- MA 7 awards $282.7M
- IL 3 awards $274.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.395). How funding has trended year over year.
| 2024 | $1,298,551,504 | |
| 2025 | $1,414,965,434 | |
| 2026 est. | $926,626,977 |
FAQ
Who can apply for this grant?
Researchers at universities, nonprofits, and research institutions with capacity for drug development work can apply. Collaboration across pain biology, drug development, and clinical expertise is strongly encouraged.
What types of projects are funded?
Projects covering early optimization through Phase I clinical development of non-addictive analgesic small molecules and biologics. Projects must be positioned to enter first-in-human studies by grant end.
What does this grant NOT fund?
Basic research, therapeutic device development, and clinical studies beyond Phase I are excluded. Applications cannot focus on opioid formulations.
What is the deadline?
The Notice indicates a deadline of January 26, 2026. This is a fixed, single deadline for applications.
Can I work with external contractors?
Yes. Collaboration with NIH-funded consultants and contract research organizations (CROs) specializing in drug development is supported and encouraged.
💡 Tips for applicants
- Emphasize your team's combined expertise in pain biology, drug development, clinical design, and statistics. Reviewers favor multidisciplinary collaboration.
- Detail a clear development pathway from your early-stage molecule to Phase I readiness by grant end. Include specific milestones and timelines.
- Explain how your non-addictive mechanism addresses the opioid crisis. Connect your science to the HEAL Initiative's public health mission.
- Budget for CRO partnerships if needed for specialized services (toxicology, formulation, manufacturing). Document why external expertise strengthens your plan.
- Review NIH HEAL Initiative priorities and cite relevant published research. Show alignment with national pain therapeutics goals.
⚠️ Common mistakes
Proposing basic research without clear development pathway to Phase I. Underestimating regulatory and manufacturing timelines needed for first-in-human readiness. Failing to demonstrate multidisciplinary team or addressing gaps with CRO collaborations.
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