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Accelerating the Translation of Novel Compounds Toward INDs for Subsequent Clinical Testing

Using the center’s therapeutic development resources, we are working with the external research and development community and other scientists at NIH to identify and test existing and possible new drugs for preclinical development. The following three initiatives are focused on facilitating the testing needed to bring promising drug candidates to first-in-human studies.

Accelerating the Translation of Novel Compounds Toward INDs for Subsequent Clinical Testing

Creating Pharmacological Probes for Novel Targets

Research experts in pain and opioid misuse and addiction have identified compounds that act on biological targets of opioids and pain and tested them in cell- and animal-based models. We provide access to resources and expertise to advance the preclinical development of these compounds and further develop them into drug-like compounds to position them for eventual testing in humans. Available collaborative resources include compound libraries, high-throughput screening, test validation, informatics tools and medicinal chemistry. The libraries will leverage repositories of natural products available through the National Cancer Institute and the Fogarty International Center.

Developing Investigational Drugs Ready for Clinical Testing

Scientists working with NCATS’ Preclinical Therapeutic Development Branch, including those in the Therapeutics for Rare and Neglected Diseases and Bridging Interventional Development Gaps programs, are identifying and optimizing new drug candidates for opioid misuse and addiction and for pain and opioid use disorder. Researchers will determine which candidates can be further developed and tested to enable IND applications to the U.S. Food and Drug Administration and subsequent early-phase testing in humans. Available resources include medicinal chemistry, pharmacology, testing of the metabolic properties of compounds, compound safety profiles, optimal drug formulation for administration in humans, and manufacturing methods to produce sufficient quantities of potential drugs for preclinical and clinical evaluation.

Last updated on April 22, 2024