new chemical entity

https://doi.org/10.1351/goldbook.12692
Drug that contains no active moiety previously approved for use by the national authority, such as the U.S. Food and Drug Administration.
Source:
PAC, 2013, 85, 1725. (Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)) on page 1743 [Terms] [Paper]