September 25, 2019
Ardelyx received FDA approval for tenapanor for the treatment of IBS-C in adults. The approval was based on two phase 3 clinical trials, T3MPO 1 and T3MPO2. The brand name for the drug will be Ibsrela. The label contains a black box warning on the risk of serious dehydration in pediatric patients, which is due to a class effect of NHE3 sodium transport inhibitors.
Ardelyx has decided not to commercialize the drug for IBS-C indication themselves and is awaiting a commercial partner who would also be interested in developing the drug for CIC. The company did not disclose details of ongoing partnership conversations during the call following tenapanor’s approval. Read more