Opportunity Information: Apply for RFA HL 20 031
This NIH funding opportunity (RFA-HL-20-031) under the HEAL Initiative supports preclinical work aimed at creating new pharmacotherapies that can reverse opioid overdose-related respiratory depression (breathing suppression) without triggering central opioid withdrawal and, ideally, without undermining opioid pain relief. The central idea is to move beyond today s standard rescue approaches by developing mechanism-based drugs that restore breathing more selectively, addressing a major cause of death in both illicit synthetic opioid overdoses and prescription opioid harms.
The program is structured as a two-phase translational pathway using the R61/R33 mechanism, and it is explicitly limited to preclinical research (clinical trials are not allowed). Phase I focuses on identifying and rigorously validating biological targets that can be modulated to reverse opioid-induced respiratory depression. In practical terms, applicants are expected to propose credible candidate targets and generate strong evidence that these targets actually control opioid-related breathing suppression in relevant experimental systems. Phase II is intended for developing actual therapeutic candidates that act on the validated targets from Phase I. These candidates may include small molecules, biologics, or natural products, and they should be tested in relevant animal models and or human cells or tissues to demonstrate functional benefit and feasibility as a drug development program.
A defining feature of this FOA is milestone-driven project management. Applicants must propose clear Phase I and Phase II milestones, and these milestones are finalized before an award is made to serve as formal performance expectations and a working schedule. Progress against milestones is not just administrative; it is a major determinant of whether a project will be allowed to transition from Phase I (R61) into Phase II (R33). This design is meant to keep projects tightly focused on deliverables that move a candidate toward practical therapeutic development rather than open-ended exploratory biology.
By the end of Phase II, projects may advance far enough to support an Investigational New Drug (IND)-enabling package, including preclinical functional outcomes along with key development steps such as toxicology and pharmacokinetics. In other words, the opportunity is geared toward producing credible therapeutic leads with the kind of preclinical evidence base that could justify regulatory next steps, even though actual human testing is outside the scope of this announcement.
The FOA strongly encourages multidisciplinary and multiple-PI teams, especially collaborations that combine respiratory neurobiology, opioid pharmacology, and preclinical drug development expertise. That emphasis reflects the complexity of the problem: reversing opioid-induced breathing suppression requires deep understanding of respiratory control circuits and opioid receptor biology, while also requiring practical drug discovery and development capabilities to generate viable candidate therapeutics.
This announcement is intended specifically for pharmacotherapeutic development, and it draws a firm line around what is considered responsive. Applications centered on device development, creation or validation of models, purely mechanistic studies that do not directly support target validation and therapeutic development, population-based epidemiology, and any human subjects research are described as non-responsive. The goal is to fund projects that directly advance a drug-like intervention to reverse respiratory depression without causing generalized withdrawal or eliminating analgesia, rather than funding broader research programs about opioid biology or overdose trends.
Eligibility is broad across U.S.-based organizations and includes various levels of government, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. The FOA also highlights additional eligible applicant types such as HBCUs, Hispanic-serving institutions, Tribal governments and Tribal organizations, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and U.S. territories or possessions. Non-U.S. (foreign) institutions are not eligible to apply as applicant organizations, but non-U.S. components of U.S. organizations may participate, and foreign components are allowable under NIH policy as defined in the NIH Grants Policy Statement.
Administratively, the opportunity is run by the National Institutes of Health and is categorized as a discretionary grant. It was originally posted with a closing date of June 24, 2020, and it aligns with multiple CFDA program areas (93.233, 93.279, 93.837, 93.838, 93.839, 93.840), reflecting NIH s cross-institute investment in addressing opioid overdose and related cardiopulmonary and health outcomes.Apply for RFA HL 20 031
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.279, 93.837, 93.838, 93.839, 93.840.
- This funding opportunity was created on 2020-01-24.
- Applicants must submit their applications by 2020-06-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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