Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01 Clinical Trial Required)

Funding Agency:
National Institutes of Health

This Funding Opportunity Announcement (FOA) seeks applications that propose testing new therapeutic uses for experimental drugs or biologics (Assets) across a broad range of human diseases in adult and pediatric populations. This innovative program allows investigators to propose new therapeutic uses for Assets from pharmaceutical company partners. Strong applications will include scientific evidence that modulation of an Asset’s target will have a positive impact on the disease/condition.   

An X02 pre-application is the first step in the application process for partnering with a pharmaceutical company under PAR-18-909. NCATS serves as a matchmaker between investigators with new therapeutic use ideas and asset providers. It is up to those parties to decide to work together on a full application for funding. Applicants must obtain a letter of support from a pharmaceutical partner, who will provide access to IND-enabling paperwork and drug product if the project is selected for funding. Such applicants may submit a U01 application under this FOA.


  • Letter of Intent Due Date: 30 days prior to the application due date   
  • Application Due Date(s): May 3, 2019, August 26 2019, May 4, 2020, August 26, 2020, May 3, 2021, August 26, 2021

PAR-18-910 Expiration Date New Date October 6, 2020 per issuance of NOT-TR-21-004. (Original Expiration Date: August 27, 2021)

Agency Website

Eligibility Requirements

This FOA is a limited competition for X02 pre-applicants that: 1)  submitted a pre-application to PAR-18-909; 2) were put in contact with a pharmaceutical partner, 3) exchanged data under a confidential disclosure agreement; and subsequently 4) obtained a letter of support from a pharmaceutical partner. 

It is strongly encouraged for U01 applications that the PD/PI not be changed from that listed on the X02 pre-application. For U01 applications proposing multiple PD(s)/PI(s), it is strongly encouraged that the contact PD/PI be the same PD/PI listed as the contact PD/PI on the X02 pre-application. The contact PD/PI is strongly encouraged to continue the multiple PD(s)/PI(s) leadership described in the X02 pre-application, if a successful partnership with a pharmaceutical company is established and a U01 application is submitted.

Amount Description

Budgets greater than $3,000,000 (direct costs) for each year of the U01 will be considered if strongly justified.

The total project period generally should not exceed 3 years, but 4 years will be considered if strongly justified.

    Funding Type





    Medical - Clinical Science
    Medical - Translational

    External Deadline

    October 6, 2020