The medication works as an acid blocker, and is currently on the market in South Korea and China. After discussions with the FDA, Sebela was approved to initiate a phase three tegoprazan trial in the U.S.
Sebela’s affiliate Braintree (Mass.) Laboratories will be responsible for clinical development, marketing, sales and registration of the medication.
“We are delighted to add tegoprazan to our product pipeline,” Alan Cooke, president and CEO of Sebela Pharmaceuticals, said in an Oct. 28 press release. “For over 35 years we have been committed to the gastroenterology space and to those affected by GI diseases. Tegoprazan expands our gastroenterology portfolio into an exciting new therapeutic class. Tegoprazan already has an established track record of safety and efficacy in multiple clinical studies and represents a potential new treatment option for people living with GERD.”
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