What is the Origin of New Molecular Entity (NME)?

This term is a formal classification used by agencies such as the U.S. Food and Drug Administration (FDA) to track and prioritize the review of truly innovative drug applications. The designation reflects the introduction of a new chemical moiety into the pharmacopeia, demanding comprehensive evaluation.

What is the Mechanism of New Molecular Entity (NME)?

The development pathway for an NME is characterized by extensive pre-clinical toxicology and pharmacology studies, followed by rigorous, multi-phase human clinical trials to fully characterize its pharmacokinetics, efficacy, and long-term safety profile. Due to the absence of prior clinical experience, the regulatory review process is comprehensive, ensuring the novel agent's risks are understood before introduction to clinical practice.

New Molecular Entity (NME) ∞ Area

New Molecular Entity (NME)

Meaning

A New Molecular Entity (NME) is a specific designation used by drug regulatory authorities to identify a drug substance whose active ingredient has never before been approved or marketed for use in that jurisdiction. This classification signifies that the compound possesses a unique chemical structure or a novel mechanism of action.