Being evaluated for treatment of refractory GERD (gastroesophageal reflux disease)

About IW-3718

IW-3718 is being evaluated as a potential treatment, as an adjunct to proton pump inhibitors (PPIs), for patients suffering from refractory gastroesophageal reflux disease (GERD). IW-3718 is currently enrolling refractory GERD patients in two pivotal Phase III studies.

  • Compound
  • Indication
  • Approval

Represents ongoing phase of development; does not correspond to completion of a particular phase.

About Refractory GERD
  • There are an estimated eight to 10 million adults suffering from refractory GERD in the U.S. and more than 60 million adults estimated to suffer globally.

  • Patients with refractory GERD suffer from heartburn at least four days per week and problematic regurgitation despite treatment with proton pump inhibitors (PPIs), the current standard of care.

  • While PPIs suppress acid production in the stomach, scientific evidence suggests that reflux of bile from the intestine into the stomach and esophagus may play a role in the ongoing symptoms experienced by patients with refractory GERD.

  • There are a limited number of FDA-approved treatment options for these patients.

How IW-3718 is Thought to Work

  • IW-3718 is a gastric retentive formulation of colesevelam, a bile acid sequestrant. Ironwood developed this formulation using the proprietary Acuform® drug delivery formulation technology licensed from Assertio.

  • PPIs block gastric acid from refluxing into the esophagus, but do not suppress reflux of bile.

  • IW-3718, in combination with PPIs, is designed to sequester bile acids in the stomach for an extended period of time to reduce bile exposure in the esophagus.

IW-3718 Recruiting Clinical Trials Phase III
Study C3718-301
Study C3718-302

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