Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01 Clinical Trial Not Allowed)

Funding Agency:
National Institutes of Health

The goal of this Funding Opportunity Announcement (FOA) is to support translational research that provides strong justification for later-phase therapeutics discovery and development efforts in health-related outcomes relevant to the National Institute of Diabetes and Digestive and Kidney Diseases. This includes outcomes relevant to obesity, diabetes and related aspects of endocrinology and metabolism, digestive diseases, liver diseases, nutrition, kidney and urological diseases, and hematology. Additional information concerning programmatic areas at NIDDK is available at www.niddk.nih.gov/research-funding/research-programs/Pages/default.aspx and applicants are strongly encouraged to discuss research priorities with the Scientific Contact.

The objective of this FOA is to stimulate early-stage preclinical validation of therapeutic leads (that need not be finalized therapeutics, henceforth called "therapeutic leads") such as small molecules or non-viral biologics that are not currently a focus within the biotechnology and pharmaceutical industries. It is expected that there is significant novelty in the target, small molecule, or non-viral biologic and in how the resulting therapeutic would differentiate from existing therapies. This must be articulated clearly in the application. It is not intended to support research focused on understanding normal biology, disease processes, generating lists of putative new targets, or identifying new therapeutic uses for existing compounds.

At the end of the project period, a successful project will have provided a significant contribution to the data supporting the validity around a therapeutic such that it can advance further through other funding mechanisms, such as the small business program (https://sbir.nih.gov/niddk/index).


  • Letter of Intent Due Date: Oct 12, 2019, June 14, 2020, Oct 12, 2020, June 14, 2021, and Oct 12, 2021
  • Application Due Dates: Nov 12, 2019, July 14, 2020, Nov 12, 2020, July 14, 2021, and Nov 12, 2021

PAR-19-294 Expiration Date November 13, 2021




Medical - Basic Science
Medical - Translational

External Deadline

November 12, 2020