Key Dates

Related Announcements

None

Issued by

National Institute on Aging (NIA)

Purpose

The purpose of this Request for Information (RFI) is to assess the early development pipeline for novel, disease-modifying drugs to prevent or treat specific aging-related conditions. NIA is seeking input from academic and industry stakeholders who have identified relevant therapeutic targets or are actively developing such drugs. NIA will use this information in its planning to enable drug development. 

Background

There is evidence that some biologic mechanisms contribute both to physiologic aging changes and to specific aging-related conditions. However, few medicines expressly target these mechanisms to modify such conditions. Drugs targeting such mechanisms could, without limitation, include approaches that:

• Reverse or decelerate aging-related changes that increase the risk of developing one or more aging-related diseases (e.g., correct aging-related immune defects to reduce heightened susceptibility to infection; arrest atheromatous plaque progression to reduce the risk of cardiovascular events), and/or 
• Restore or decelerate loss of tissue, cells, or functionality that when lost throughout life eventually compromise health (e.g., regrow bone to treat osteoporosis; regenerate cells in the cochlea to treat age related hearing loss).

Drug development requires special skills often not available to, or outside the range of interest of, many biological researchers, and outside the scope of standard research project funding mechanisms of the National Institutes of Health (NIH). To address this, the NIH has established resources to promote and support drug development in a variety of NIH Institute mission areas. These efforts incorporate specialized application review, milestone-driven funding progression, and a co-development structure that enables cost efficient access to centralized resources, among other features.

Reaching an efficient scale for such programs requires that sufficient translational research findings have been made in their related disease areas. NIA is therefore seeking information from academic researchers and industry stakeholders to help it assess the extent to which potential mechanistic targets for interventions to prevent or treat one or more aging-related conditions by modulating aging mechanisms or their effects have been identified and validated, and the extent of activity in subsequent drug development steps for these targets. NIA will use this information in considering possible initiatives for drug development resources. This information will be valuable to NIA regarding a wide range of aging-related conditions, many of which may not be included in existing NIH drug development programs.

Information Requested

NIA is seeking comments on as many of the topics listed below for which information is available. NIA recognizes some programs will prefer to maintain confidentiality regarding certain topics, and emphasizes that partial responses will also be useful in these cases.

1. The aging-related disease area(s) or indication(s) for which there is evidence that your drug or drug target could be beneficial.
2. The biological pathway(s) or mechanism(s) through which the drug target could exert a beneficial effect, and how you identified and validated this candidate drug target.
3. The therapeutic modality being developed, or that would be most appropriate to develop (e.g., small molecule, biologic, gene therapy, cell therapy).
4. The program’s current stage of development, selected from:
   • Data Driven Target Identification
   • Target Validation (experiments to confirm therapeutic potential)
   • Target-to-Hit (identification of a developable chemical or biologic entity)
   • Hit-to-Lead (further optimization of the developable entity to enable preclinical proof-of-concept)
   • Lead-to-Candidate (further optimization to de-risk human use once preclinical proof-of-concept is demonstrated)
   • Candidate-to-IND (completion of safety studies, manufacturing, or regulatory filings necessary to begin clinical trials)
   • Clinical Trial (Phase 1, 2, or 3)
5. Intellectual property status for the drug or target (e.g., expected patent type, such as composition of matter or method of use).
6. The target’s or drug’s novelty, including the existence of  drugs developed against the target that are approved by the Food and Drug Administration.
7. Respondent’s experience in drug development, or that of your most experienced team member.
8. Challenges you have experienced that may slow or prevent development, and any assistance that NIA might provide to help overcome those challenges.
9. Your access to the expertise and facilities required to translate your projects from the laboratory to the clinic, including resources you lack which could better enable progression of the project.
10. Your interest, or that of your team members, in maintaining active involvement as a drug progresses through drug development stages.

Submitting a Response

NIA is grateful for your interest and help. Responses to this RFI must be submitted via email to [email protected] by 11:59:59 PM ET on July 1, 2026. Please include the Notice number NOT-AG-26-001 in the subject line, and your full name, title, and institution in the body of the e-mail.

Response to this RFI is voluntary. Respondents are free to address any or all of the categories listed above and/or to provide feedback on any relevant issues. The submitted information will be reviewed by NIA staff.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any respondent's submission. The information provided will be analyzed and may appear in presentations and reports. The NIH may use the information gathered to develop grants, contracts, or other funding priorities and initiatives. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). The information provided will be analyzed and may appear in reports. No proprietary, classified, confidential, or sensitive information should be included in your response.

Inquiries

Please direct all inquiries to:

Ethan Sarnoski, Ph.D.
National Institute on Aging (NIA)
Email: [email protected]