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

• Published in: Drug discovery today Vol. 21; no. 2; pp. 204 - 207
• Main Authors: Patridge, Eric, Gareiss, Peter, Kinch, Michael S., Hoyer, Denton
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.02.2016
• Subjects: Animals; Bacteria; Biological Products; Drug Approval; Fungi; Humans; Plants; United States; United States Food and Drug Administration
• ISSN: 1359-6446; 1878-5832
• DOI: 10.1016/j.drudis.2015.01.009

•Natural products contribute more than one-third of all FDA-approved NMEs.•The absolute number of natural product approvals peaked in the 1990s and has since declined.•Half of all natural products were derived from mammalian sources, followed by microbes and plants. 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.