MedPath

Ardelyx

Ardelyx logo
🇺🇸United States
Ownership
Public
Established
2007-01-01
Employees
267
Market Cap
$1.4B
Website
http://www.ardelyx.com
Introduction

Ardelyx, Inc. is a biopharmaceutical company, which engages in the business of developing and commercializing biopharmaceutical products. The firm is also involved in developing a unique and innovative platform that enables the discovery of new biological mechanisms and pathways to develop potent and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines. The company was founded by Dominique Charmot, Peter G. Schultz, and Jean M. Frechet in October 2007 and is headquartered in Waltham, MA.

Clinical Trials

29

Active:1
Completed:24

Trial Phases

4 Phases

Phase 1:11
Phase 2:9
Phase 3:7
+1 more phases

Drug Approvals

5

NMPA:3
FDA:2

Drug Approvals

Tenapanor Hydrochloride Tablets

Product Name
万缇乐
Approval Number
国药准字HJ20250022
Approval Date
Feb 20, 2025
NMPA

Tenapanor Hydrochloride Tablets

Product Name
万缇乐
Approval Number
国药准字HJ20250020
Approval Date
Feb 20, 2025
NMPA

Tenapanor Hydrochloride Tablets

Product Name
万缇乐
Approval Number
国药准字HJ20250021
Approval Date
Feb 20, 2025
NMPA

Clinical Trials

Distribution across different clinical trial phases (29 trials with phase data)• Click on a phase to view related trials

Phase 1
11 (37.9%)
Phase 2
9 (31.0%)
Phase 3
7 (24.1%)
Phase 4
2 (6.9%)

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Phase 2
Recruiting
Conditions
Irritable Bowel Syndrome with Constipation (IBS-C)
Interventions
Drug: Placebo
First Posted Date
2024-08-14
Last Posted Date
2025-01-17
Lead Sponsor
Ardelyx
Target Recruit Count
72
Registration Number
NCT06553547
Locations
🇺🇸

Texas Digestive Specialists, Harlingen, Texas, United States

🇺🇸

Florida Pharmaceutical Research and Associates, Inc., South Miami, Florida, United States

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Phase 1
Completed
Conditions
Lactation
Interventions
First Posted Date
2024-01-12
Last Posted Date
2024-07-11
Lead Sponsor
Ardelyx
Target Recruit Count
7
Registration Number
NCT06203444
Locations
🇺🇸

DDSI, Oklahoma City, Oklahoma, United States

🇺🇸

Fortrea Clinical Research Unit, Madison, Wisconsin, United States

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Phase 3
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
First Posted Date
2023-06-15
Last Posted Date
2025-06-10
Lead Sponsor
Ardelyx
Target Recruit Count
150
Registration Number
NCT05905926
Locations
🇺🇸

OSF Saint Francis Medical Center, Peoria, Illinois, United States

🇺🇸

Maspons Pediatric Gastro, El Paso, Texas, United States

🇺🇸

G & L Research, LLC, Foley, Alabama, United States

and more 16 locations

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Phase 3
Recruiting
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
First Posted Date
2022-12-08
Last Posted Date
2024-12-17
Lead Sponsor
Ardelyx
Target Recruit Count
180
Registration Number
NCT05643534
Locations
🇺🇸

Orlando Health, Inc.- APH Center for Digestive Health and Nutrition, Orlando, Florida, United States

🇺🇸

OSF Saint Francis Medical Center, Peoria, Illinois, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

and more 29 locations

A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

Phase 2
Completed
Conditions
Hyperkalemia
Interventions
Drug: Placebo
First Posted Date
2021-03-04
Last Posted Date
2022-05-04
Lead Sponsor
Ardelyx
Target Recruit Count
109
Registration Number
NCT04780841
Locations
🇺🇸

Horizon Research Group LLC, Coral Gables, Florida, United States

🇺🇸

Panax Clinical Research LLC, Miami Lakes, Florida, United States

🇺🇸

South Florida Research Phase I-IV; Inc., Miami Springs, Florida, United States

and more 3 locations
  • Prev
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • Next

News

Avadel Pharmaceuticals Appoints Susan Rodriguez as Chief Operating Officer to Drive LUMRYZ Commercial Expansion

Avadel Pharmaceuticals has appointed Susan Rodriguez as Chief Operating Officer to lead commercial strategy and operations for LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy.

China Approves First-in-Class Tenapanor for Hyperphosphatemia in Dialysis Patients

Fosun Pharma's Wan Ti Le (tenapanor hydrochloride tablets) has received NMPA approval for controlling serum phosphorus in dialysis patients with chronic kidney disease who have inadequate response to phosphate binders.

© Copyright 2025. All Rights Reserved by MedPath