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New Molecular Entities | The Cost of Drug Development 2022

February 15, 2022
Est. Reading: 3 minutes

New Molecular Entities | Define new molecular entity (NME)

A new molecular entity (NME) is a drug that contains no active moiety that has been approved by the US Food and Drug Administration (FDA). It has not yet been assigned a therapeutic equivalence rating. The official FDA definition states: "The term "new molecular entity" means an active ingredient with no active moiety that has been approved by the FDA in any other NDA (new drug application)".

A new molecular entity is biologically active and bears no relation to existing drugs. However, it may contain a common element or group of elements that are found together in various other known substances. The main feature of NMEs is that they show pharmacological properties under investigation, but have not yet been approved.


Define new molecular entity

Examples of "New Molecular Entity" include:

  • Anas Barbariae Hepatis et Cordis Extractum – A Chinese herbal medicine containing the plastids and nuclei of embryonic quail heart and liver.
  • Sanguinarine – An alkaloid derived from the root of "Sanguinaria canadensis" (bloodroot) that is used as a bittering agent in some medicines.
  • Urapidil – A drug used for hypertension, angina pectoralis, and anxiety that was originally developed by Parke-Davis.


New Molecular Entity vs New Chemical Entity

A drug can be defined as a product that is administered to humans and other animals for the treatment, prevention, and diagnosis of disease. The aim of producing such drugs is to improve their therapeutic value for patients. A new chemical entity (NCE) is a substance whose composition differs from those previously approved by the FDA in any way.

It may be a drug that contains no active moiety, but whose composition is different from those already approved. A new chemical entity must be biologically active and have pharmacological properties under investigation, but has not yet been approved. This category is further divided into two groups: Group I includes compounds found in the environment or derived from natural sources, while group II poisons and compounds produced by metabolism.


A chemical entity example is Tegaserod – An orally administered drug used for irritable bowel syndrome and constipation that was approved in 2002.

new molecular entity vs new chemical entity

Cost of Drug Development 2021

The cost of drug development varies depending on which phase the research is in, and whether it is a brand-new compound or an existing one that has been reformulated.

Why does it cost so much to develop a new drug?

There are many cost drivers involved in the development of a new drug, some of which include:

  • Preclinical studies: Conducted to determine whether the drug is likely to be safe for humans and its therapeutic value. This stage alone can take up to three years
  • Clinical trials: Involves testing on human subjects conducted through different phases, in order to gain enough evidence, data, and results that support the drug's safety and therapeutic value. On average, this stage takes about seven years
  • Time in the market: The time taken for a new drug to be approved by the FDA.
  • Post-approval requirements: Additional research is required after the drug has been approved to generate safety and efficacy data, which can take up to seven more years.
  • why does it cost so much to develop a new drug

Taken together, the total cost of bringing a new drug to market is approximately $1 billion.

NCE costs are likely influenced by the complexity of the drug. For instance, NCEs that are developed to target multiple receptors or enzymes can cost more than $1 billion; this is estimated by the Tufts Center for the Study of Drug Development (CSDD). In May 2019, gave an estimated cost of $2.6 billion. That study broke down the number to include approximate average out-of-pocket costs of $1.4 billion and time costs of $1.2 billion.

We hope this information is helpful in understanding a little more about the cost of developing a new drug. If you have any questions or concerns, please do not hesitate to contact us. Follow us on social media, so you can stay up to date with the latest information in cancer care. Visit Cancer Cell Treatment.



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