new molecular entity

https://doi.org/10.1351/goldbook.12693
Active ingredient that has never before been approved in any form 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]