1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Ardelyx's Adjusted Trial Design May Expedite NDA Filing For Lead Candidate

The first-in-class NHE3 inhibitor tenapanor is in Phase III for IBS-C, as well as in Phase II for hyperphosphatemia in end-stage renal disease patients. Agreement with FDA may accelerate filing for the latter indication.

Ardelyx Inc. has agreed to a design change in a Phase IIb study for its lead candidate, the first-in-class NHE3 inhibitor tenapanor, in hyperphosphatemia in end-stage renal disease patients that may enable a quicker NDA filing in that indication than previously anticipated.

Following an end-of-Phase II meeting with FDA, Ardelyx will increase the size of the patient base in its ongoing Phase...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 
• By Francesca Bruce

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.