A Phase 3, Open-label, Single-arm Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
Latest Information Update: 03 Oct 2023
At a glance
- Drugs Tenapanor (Primary)
- Indications Hyperphosphataemia
- Focus Registrational; Therapeutic Use
- Sponsors Kyowa Kirin
- 25 Sep 2023 According to a Kyowa Kirin media release, company announced that it has received an approval for manufacturing and marketing PHOZEVEL for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis based on the results of four Phase 3 clinical trials, conducted by Kyowa Kirin in Japan, in patients with hyperphosphatemia on maintenance dialysis.
- 31 Oct 2022 According to an Ardelyx media release,this submission triggers an aggregate of $35 million to Ardelyx in milestone payments and payments under the recent amendment to the license agreement between Ardelyx and Kyowa Kirin.
- 31 Oct 2022 According to an Ardelyx media release, based on the data from four phase 3 studies in Japan, Kyowa Kirin has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis.