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 stage therapeutics development and preclinical efforts in health-related outcomes relevant to the National Institute of Diabetes and Digestive and Kidney Diseases. This includes outcomes relevant to diabetes and other endocrine and metabolic diseases, liver and other digestive diseases, nutritional disorders, obesity, kidney and urological diseases, and hematologic diseases. Additional information concerning programmatic areas at NIDDK is available at www.niddk.nih.gov/research-funding/research-programs and applicants are strongly encouraged to discuss research priorities with the Scientific Contacts for each division.

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, identifying new therapeutic uses for existing compounds, or identifying mechanism of action for therapeutic leads.

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 for later stage therapeutics development and preclinical efforts through other funding mechanisms, such as the Parent R01 or small business programs (https://sbir.nih.gov/niddk/index), spin-off companies, or licensing to or partnering with pharmaceutical companies.


  • Letter of Intent Due Date: June 14, 2022, October 14, 2022, June 14, 2023, October 13, 2023, June 12, 2024, and October 12, 2024
  • Application Due Dates: July 14, 2022; Nov 14, 2022; July 14, 2023; Nov 13, 2023; July 12, 2024; Nov 12, 2024
  • AIDS Due Dates: Sep. 7, 2022; Jan. 7, 2023; Sep. 7, 2023; Jan 7, 2024; Sep 7, 2024; Jan 7, 2025

PAR-22-111 Expiration Date New Date April 26, 2023 (Original Date: January 08, 2025) per issuance of NOT-DK-23-019

Agency Website

Amount Description

Direct costs are expected to be in the range of $250,000 to $300,000 per year.  Application budgets may not exceed $500,000 total costs per year.

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Funding Type





Medical - Basic Science
Medical - Translational

External Deadline

April 26, 2023