New molecular entity (NME)

A new molecular entity (NME) includes new chemical entities (NCE) and biological entities. A new chemical entity (NCE) is a Ü pharmaceutical that contains no active moiety, i.e. without any molecule or ion, but including those appended portions of the molecule that cause the medicine to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the pharmaceutical substance. It is a chemical molecule developed by the innovator company in the early discovery stage, which after undergoing clinical trials could translate into a pharmaceutical that could be a cure for some disease.

Last update: 20 June 2023

Source: FDA, updated by PPRI