Knight Therapeutics' Ibsrela Receives Health Canada Review for IBS-C Treatment
Knight Therapeutics Inc. announced Health Canada has accepted its New Drug Submission (NDS) for Ibsrela™ (tenapanor), a treatment for irritable bowel syndrome with constipation (IBS-C).
Montreal, Canada – Knight Therapeutics Inc. has announced that Health Canada has accepted its New Drug Submission (NDS) for Ibsrela™ (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C). The acceptance for review marks a step toward potential market availability in Canada.
The submission follows a license agreement in March 2018 between Knight Therapeutics and Ardelyx Inc., granting Knight exclusive rights to commercialize tenapanor in Canada. Tenapanor is a first-in-class small molecule treatment, currently under FDA review for IBS-C, and is also being evaluated for hyperphosphatemia in end-stage renal disease patients undergoing dialysis.
"We look forward to bringing Ibsrela, a product with established efficacy and safety, to Canadian patients," stated Jonathan Ross Goodman, CEO of Knight Therapeutics. He added that the drug's unique mechanism of action is expected to provide a new therapeutic option for IBS-C and enhance the company's gastroenterology portfolio.
Knight Therapeutics, headquartered in Montreal, is a specialty pharmaceutical company focused on acquiring and commercializing innovative pharmaceutical products for the Canadian and select international markets. The company's shares trade on the TSX under the symbol GUD.