Trial Profile
An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 19 Oct 2023
Price :
$35
*
At a glance
- Drugs Tenapanor (Primary)
- Indications Hyperphosphataemia
- Focus Registrational; Therapeutic Use
- Acronyms BLOCK
- Sponsors Ardelyx
Most Recent Events
- 17 Oct 2023 According to an Ardelyx media release, company announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH, based on three Phase 3 clinical trials PHREEDOM, BLOCK and AMPLIFY.
- 17 May 2023 According to an Ardelyx media release, The FDA has set a user fee goal date of October 17, 2023 and the company expects XPHOZAH to be commercially available in the fourth quarter of 2023, following an approval from the FDA.
- 17 May 2023 According to an Ardelyx media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted its six-month review resubmission of a New Drug Application (NDA) for XPHOZAH (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.