Opportunity Information: Apply for RFA NS 27 007
The NIH is offering a HEAL Initiative funding opportunity (RFA-NS-27-007) designed to push forward new, non-addictive pain medicines, specifically small molecules and biologics that have a credible path toward becoming real clinical candidates. The central aim is not basic discovery, but practical translational development: taking a promising early-stage lead and doing the work needed to make it ready for Phase II clinical trials. In other words, this program is meant for groups that already have a defined therapeutic lead in hand (not just a target hypothesis), along with a solid biological rationale and working assays that can guide optimization and decision-making as the candidate is refined.
The funded work is expected to cover the core steps that typically stand between an interesting lead and a clinic-ready product. On the preclinical side, this includes lead optimization and early development activities that improve properties like potency, selectivity, stability, exposure, and overall developability, while also building a data package that supports safety and feasibility. The NOFO also explicitly includes IND-enabling studies, which generally means the set of pharmacology, toxicology, and related development studies needed to justify first-in-human testing. A notable emphasis is placed on developing pharmacodynamic and/or target engagement biomarkers, reflecting NIH interest in having objective evidence that the drug is doing what it is supposed to do in living systems, and potentially in humans, not just producing behavioral effects in pain models.
The opportunity uses a phased UG3/UH3 cooperative agreement structure and is milestone-driven. In practice, that means the project is organized into stages with clear go/no-go decision points, and progression depends on meeting pre-specified milestones rather than simply completing a set period of work. It is also a cooperative agreement, not a standard grant, so NIH program staff are expected to take an active role in planning and oversight, with ongoing monitoring of progress and coordination around major development decisions. The clinical trial component is listed as optional, but the scope clearly anticipates a development trajectory that can extend through IND preparation and submission and into Phase I clinical testing, aligning with the overall objective of positioning candidates for Phase II readiness.
Eligibility is broad across U.S.-based organization types, including state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); and small businesses. However, foreign participation is tightly restricted: non-U.S. entities cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. Applicants therefore need to plan the entire proposed project work within eligible domestic structures.
Administratively, the sponsor is the National Institutes of Health, the instrument type is a cooperative agreement, and it falls under the health funding activity category, with multiple listed CFDA/Assistance Listing numbers (93.213, 93.233, 93.273, 93.279, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867), reflecting multi-institute participation typical of HEAL efforts. NIH anticipates a small number of awards (expected awards: 3). The opportunity was created on 2026-06-16, and the listed original closing date is 2029-02-20. The award ceiling is not specified in the provided summary, so applicants would need to consult the full NOFO for budget limits, project period details, and the exact milestone and review expectations referenced in the eligibility and application sections.Apply for RFA NS 27 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.273, 93.279, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2026-06-16.
- Applicants must submit their applications by 2029-02-20.
- The number of recipients for this funding is limited to 3 candidate(s).
- 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 this funding opportunity?
This is an NIH HEAL Initiative funding opportunity (RFA-NS-27-007) intended to advance new, non-addictive pain medicines. The focus is on translational development of therapeutic leads (small molecules and biologics) toward becoming credible clinical candidates.
What is the main goal of the program?
The central aim is practical, translational development rather than basic discovery. The program is designed to take a promising early-stage lead and complete the work needed to make it ready for Phase II clinical trials, with a development path that can extend through IND preparation and submission and into Phase I clinical testing.
What kinds of therapeutics are in scope?
The opportunity specifically calls out small molecules and biologics for pain, with an emphasis on non-addictive approaches and a credible path to becoming real clinical candidates.
Is this program for early discovery research or target identification?
No. The scope is not basic discovery. It is meant for groups that already have a defined therapeutic lead in hand, supported by a solid biological rationale and working assays to guide optimization and decision-making.
What does NIH mean by having a "defined therapeutic lead in hand"?
Based on the description provided, this means the applicant should already have a promising early-stage lead (not just a target hypothesis) along with assays that can be used to optimize and evaluate the candidate as development progresses.
What development activities are expected to be supported?
The funded work is expected to cover the key steps between an interesting lead and a clinic-ready product. This includes lead optimization and early development work to improve potency, selectivity, stability, exposure, and overall developability, along with building a supporting preclinical data package.
Are IND-enabling studies included in the scope?
Yes. The NOFO explicitly includes IND-enabling studies, generally meaning the pharmacology, toxicology, and related development studies needed to justify first-in-human testing.
Does the opportunity emphasize any particular types of biomarkers?
Yes. There is a notable emphasis on developing pharmacodynamic and/or target engagement biomarkers. The stated interest is in objective evidence that the drug is doing what it is supposed to do in living systems (and potentially in humans), not only showing behavioral effects in pain models.
What funding mechanism is used?
The opportunity uses a phased UG3/UH3 cooperative agreement structure and is milestone-driven.
What does "phased UG3/UH3" mean in practice for applicants?
Projects are organized into stages with clear go/no-go decision points. Progression depends on meeting pre-specified milestones, rather than simply completing a set period of work.
How is a cooperative agreement different from a standard grant in this opportunity?
Because it is a cooperative agreement, NIH program staff are expected to take an active role in planning and oversight, including ongoing monitoring of progress and coordination around major development decisions.
Are clinical trials required?
The clinical trial component is listed as optional. However, the overall scope anticipates a development trajectory that can extend through IND preparation and submission and into Phase I clinical testing, with the broader objective of positioning candidates for Phase II readiness.
Who is eligible to apply?
Eligibility is broad across U.S.-based organization types, including state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); and small businesses.
Can foreign organizations apply?
No. Non-U.S. entities cannot apply under the restrictions described.
Can a U.S. organization include a non-U.S. component or foreign component?
No. Non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. Applicants need to plan the entire proposed project work within eligible domestic structures.
Who is the sponsoring agency?
The sponsor is the National Institutes of Health (NIH), and the opportunity is part of the NIH HEAL Initiative.
What is the funding activity category?
The opportunity falls under the health funding activity category.
How many awards does NIH expect to make?
NIH anticipates a small number of awards, with expected awards listed as 3.
When was the opportunity created, and what is the closing date?
The opportunity was created on 2026-06-16. The listed original closing date is 2029-02-20.
Is there a stated award ceiling or budget cap in the provided information?
No. The award ceiling is not specified in the provided summary. Applicants would need to consult the full NOFO for budget limits, project period details, and the exact milestone and review expectations.
What Assistance Listing (CFDA) numbers are associated with this opportunity?
Multiple Assistance Listing numbers are associated with this HEAL opportunity: 93.213, 93.233, 93.273, 93.279, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.865, 93.866, 93.867. This reflects multi-institute participation typical of HEAL efforts.
What is the most important "fit check" for prospective applicants?
Based on the information provided, the best fit is for teams that already have: (1) a defined small molecule or biologic lead for pain, (2) a credible biological rationale, and (3) working assays to guide optimization, with a plan to execute milestone-driven development work through IND-enabling activities and potentially early clinical steps.
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