An analysis of FDA-approved drugs: natural products and their derivatives

Drug Discov Today. 2016 Feb;21(2):204-7. doi: 10.1016/j.drudis.2015.01.009. Epub 2015 Jan 21.


Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Bacteria
  • Biological Products*
  • Drug Approval*
  • Fungi
  • Humans
  • Plants
  • United States
  • United States Food and Drug Administration


  • Biological Products