26. Ibsrela

Mike Raab - Ardelyx
Ardelyx CEO Mike Raab (Ardelyx)

Active ingredient: tenapanor
Disease: irritable bowel syndrome with constipation
Peak sales estimate: n/a
Approved: Sept. 12, 2019
Company: Ardelyx

The scoop: In an increasingly packed IBS-C market dominated by Allergan’s Linzess, Ardelyx is hoping to compete with the newest entry into the field, Ibsrela (tenapanor). The FDA approved Ibsrela in September on the heels of Alfasigma’s relaunch of Zelnorm, which was recalled from the U.S. market in 2009 on cardiovascular event worries. Back in 2018, Ibsrela posted phase 3 trial data showing the drug increased the percentage of patients who had at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements in the same week for at least six of the 12 weeks of the treatment period by 13% over placebo. Fortunately, Ibsrela came with a much cleaner label than Zelnorm, which includes a risk of major cardiovascular events as well as ischemic colitis and suicidal thoughts, among others. –– Kyle Blankenship


26. Ibsrela

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