New chemical entity
A New Chemical Entity (NCE) is a chemical compound that has not been previously approved for human use by regulatory authorities, such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). In other words, an NCE is a novel molecule that has not been marketed or sold as a pharmaceutical product before.
The term "New Chemical Entity" is often used in the pharmaceutical industry to describe a new drug candidate that is being developed for the first time. This can include small molecules, biologics, or other types of therapeutic agents.
To be considered an NCE, a compound must meet certain criteria, such as:
- It must not have been previously approved for human use by regulatory authorities.
- It must not have been marketed or sold as a pharmaceutical product before.
- It must have a unique chemical structure or mechanism of action that distinguishes it from existing drugs.
The development of an NCE typically involves a lengthy and costly process, including:
- Discovery: Identifying a potential lead compound through high-throughput screening, medicinal chemistry, or other methods.
- Lead optimization: Optimizing the lead compound's properties, such as potency, selectivity, and pharmacokinetics.
- Preclinical testing: Conducting animal studies to evaluate the compound's safety and efficacy.
- Clinical trials: Conducting human clinical trials to evaluate the compound's safety and efficacy in humans.
- Regulatory approval: Submitting the compound to regulatory authorities for approval, which involves demonstrating its safety and efficacy through clinical trials and other data.
Once an NCE is approved, it can be marketed and sold as a pharmaceutical product, and it may be used to treat a specific disease or condition.