Discovering New Therapeutic Uses for Existing Molecules
At a Glance
- Status: Active Consortium
- Year Launched: 2012
- Initiating Organization: National Center for Advancing Translational Sciences
- Initiator Type: Government
- No disease focus
- Location: North America
Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) is a collaborative program designed to develop partnerships between pharmaceutical companies and the biomedical research community to advance therapeutics development. This innovative program matches researchers with a selection of pharmaceutical industry assets to test ideas for new therapeutic uses, with the ultimate goal of identifying promising new treatments for patients.
Launched in May 2012, the National Center for Advancing Translational Sciences’ (NCATS) New Therapeutic Uses program helps re-engineer the research pipeline using an innovative strategy to identify new uses for assets that have undergone significant research and development by industry, including safety testing in humans. Using assets that already have cleared several key steps in the development process gives scientists nationwide a strong starting point to contribute their unique expertise and accelerate the pace of therapeutics development.
May 2012: Program launched
In 2012 and 2014, NCATS collaborated with several pharmaceutical industry partners to make numerous partially developed assets available to academic researchers to crowdsource ideas for new uses. Projects using these assets — including some intended for pediatric indications — are designed to go directly into studies that provide data on the relationship of dosing and response for the intended use (Phase IIa). Some projects may need additional preclinical or feasibility studies conducted within the target populations (Phase IIb). Learn more about these industry-provided assets at http://www.ncats.nih.gov/ntu/assets/current
Participating companies provide preclinical and clinical supplies of drugs and placebos to funded investigators. They also can provide suitable documentation so that funded investigators can file an Investigational New Drug application with the U.S. Food and Drug Administration.
To streamline the legal and administrative process for partnering across multiple organizations, the National Institutes of Health created template agreements. These agreements help facilitate complex negotiations among all parties involved in the program, enabling the research to begin faster. Learn more about the template agreements at http://www.ncats.nih.gov/ntu/assets/agreements
In July 2015, NCATS announced nearly $3 million to fund cooperative agreements with four academic research groups to conduct preclinical validation studies, clinical feasibility studies, or proof-of-concept clinical trials to test whether the selected assets may be effective against a previously unexplored disease target. Four disease areas are represented: