What is New Chemical Entity (NCE) ?

According to the US Food and Drug Administration (FDA), a new chemical entity (NCE) is a treatment that comprises no active entities that have been authorised by the FDA. An NCE is a molecule developed by a pioneer company in the initial stage of drug discovery. After undertaking clinical studies, the NCE could convert into a drug used for the treatment for an indication.

The synthesis of an NCE is the primary phase in the drug development process. After completing the synthesis, the companies have two possibilities: They can either move into clinical trials on their own or license the new chemical entity to any other company.

When the companies opt to license NCE to another organisation, the expensive and lengthy clinical trials process is avoided. This is because the licensee company would conduct the clinical trials and manage the subsequent launch of the drug.


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