Abstract

Of the 39 new drugs the Food & Drug Administration approved in 2012, six were peptidelike, the largest single drug group after small molecules. One member of this group stood out because of an unusual attribute: It is a pill. Almost all peptide drugs approved so far must be injected, otherwise a patient’s gastrointestinal tract would eat up these amino acid chains. But with linaclotide, Cambridge, Mass.-based Ironwood Pharmaceuticals succeeded in making an orally administered polypeptide drug, which it sells as Linzess in the U.S. and will be sold as Constella in Europe to treat bowel disease. And Ironwood didn’t have to modify the peptide chemically or use a special delivery method. Instead, it benefited from a fortuitous combination of its drug’s structure, behavior, and disease target. The 14-year-old firm was also fortunate to have the help of manufacturing, formulation, and commercial partners. The development of linaclotide occurred while Ironwood ...

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