Drug Repurposing

Drug repurposing refers to the identification of potential new uses –  such as a new indication or a new population – of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.

The FDA is seeking information from patients, clinicians, researchers, and other stakeholders on priority disease areas and potential candidates for drug repurposing, particularly where there are scientific data that could support approval of potential new uses but there appears to be limited commercial incentives to pursue approval of those uses.

Submit a public comment on the Federal Register notice

Learn about Project Renewal, an FDA initiative to update labeling for certain oncology drugs to reflect current scientific understanding

Learn about NCATS, an NIH center aiming to identify new therapeutic uses for existing FDA-approved drugs

Learn about the Make Our Children Healthy Again strategy report, which directed FDA to strengthen drug repurposing efforts

Background

Identifying potential new uses for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug's safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.

This effort builds on existing authorities and initiatives that support updating drug labeling when supported by scientific evidence, including the Best Pharmaceuticals for Children Act, the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act of 2020, and FDA-led initiatives such as Project Renewal, which has updated labeling for several oncology drugs to reflect current scientific understanding, and CURE ID, an FDA-NIH platform to share novel uses of existing drugs and explore what others have tried. Additionally, the September 2025 Make Our Children Healthy Again strategy report directed FDA to jointly investigate opportunities with the National Institutes of Health to "strengthen the use of repurposed drugs for the treatment of chronic disease, while harmonizing authorization processes through collaborative clinical trial designs to achieve FDA approval."