What is a New Chemical entity?
A New Chemical Entity (NCE) is a compound that is not identical to any previously approved drug by regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These compounds have unique chemical structures that have not been previously studied for safety and efficacy in humans. NCEs are typically discovered through the process of drug discovery and development, which can involve screening large numbers of chemicals in the laboratory to identify those that have the desired properties.
NCEs are important in the pharmaceutical industry because they represent a new source of potential drugs, and can be developed into new treatments for various diseases. However, the process of developing an NCE into a drug is a long and costly endeavor, and not all NCEs will be successful in making it through the various stages of testing and clinical trials required for regulatory approval.
Examples of New Chemical entity molecule
Examples of New Chemical Entities (NCEs) include:
- Ibrutinib – a small molecule inhibitor used in the treatment of chronic lymphocytic leukemia and other blood cancers.
- Palbociclib – a cyclin-dependent kinase 4/6 inhibitor used in the treatment of breast cancer.
- Durvalumab – a monoclonal antibody used in the treatment of lung cancer and other solid tumors.
- Lenvatinib – a kinase inhibitor used in the treatment of thyroid cancer and other solid tumors.
- Guselkumab – a monoclonal antibody used in the treatment of psoriasis and psoriatic arthritis.
- Pembrolizumab – a monoclonal antibody used in the treatment of various types of cancer, including melanoma and lung cancer.
- Lasmiditan – a serotonin receptor agonist used in the treatment of migraines.
- Vemurafenib – a kinase inhibitor used in the treatment of melanoma.
These are just a few examples of NCEs that have been developed and approved by regulatory agencies. Many other NCEs are currently in various stages of the drug development process and may be approved in the future.