Federal opportunity: NIH HEAL Initiative: Studies to Enable Analgesic Discovery, RFA-NS-25-023, R61/R33 Phased Innovation Award, Clinical Trial Not Allowed.
What NIH is funding
This opportunity supports early translational work to discover and characterize safe, effective pain therapeutics with little or no addiction liability. Responsive activities include assay development and validation, screening to identify initial hits or bioactives, in vitro characterization of potential analgesic agents, and limited preclinical pharmacokinetic, pharmacodynamic, efficacy, mechanism, selectivity, and liability studies when the proposed agents are sufficiently characterized.
Current deadline and award controls
The next application deadline is September 17, 2026 at 5:00 PM local time of the applicant organization. A later cycle is scheduled for January 15, 2027, and the NOFO expires January 16, 2027. Application budgets are limited to $350,000 in direct costs per year. The combined R61/R33 project period may not exceed three years, with no more than two years in either phase. No cost sharing is required. The multi-cycle NOFO does not establish a guaranteed FY2026 total program allocation or award count.
Eligibility
Broad domestic applicant eligibility includes public and private institutions of higher education, qualifying nonprofits, small businesses and other for-profit organizations, state and local governments, Tribal entities, independent school districts, and other domestic organizations listed in the NOFO. Foreign organizations are not eligible.
Critical application requirements
Applicants must propose activities for both the R61 and R33 phases, with a clear phase demarcation and quantitative go/no-go milestones that support the transition decision. The application must include the required Intellectual Property Strategy attachment. NIH registrations and submission requirements apply, including active SAM/UEI, Grants.gov, and eRA Commons registrations as applicable. Applications may be submitted through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Projects focused on basic target identification or validation, animal model development, opioid-sparing or mu-opioid-receptor projects, computational-only work without follow-up testing, hit-to-lead or lead optimization, IND-enabling studies, GMP manufacturing, biomarker discovery, devices or device-drug combinations, surgery, rehabilitation strategies, or clinical research are not responsive to this NOFO.
Atlas disposition
This is a high-value national pain-therapeutics research opportunity with no mandatory match and structural eligibility for for-profit applicants. A direct Dr. Miltie pursuit is not submission-ready merely because for-profits are eligible. Advancement requires a genuinely responsive analgesic-discovery program, strong biological rationale and preliminary data, validated assay or screening capability, quantitative R61-to-R33 milestones, a qualified PI and multidisciplinary team, required registrations, a compliant IP strategy, and all applicable research protections. Given the September 17, 2026 deadline, the current cycle should be treated as a direct-review opportunity only if those prerequisites already exist. Organization-specific matching should focus on qualified biomedical research institutions, academic health centers, biotechnology and pharmaceutical organizations, and other eligible research entities.