Skip to main content
Signal8
Launch Terminal

ARDELYX, INC. (ARDX)

Ardelyx, Inc. is a biopharmaceutical firm dedicated to the discovery, development, and commercialization of innovative medicines. The company primarily focuses on addressing gastrointestinal (GI) and cardiorenal conditions, serving patients both domestically in the United States and across international markets. Its flagship product candidate is tenapanor. This drug has successfully completed Phase III clinical trials for treating irritable bowel syndrome with constipation (IBS-C) and is also currently in Phase III development to manage hyperphosphatemia (high serum phosphorus) in adult patients with chronic kidney disease (CKD) who are undergoing dialysis. Ardelyx is also advancing other key pipeline assets, including RDX013, a potassium secretagogue designed to combat hyperkalemia (elevated serum potassium), a significant issue for individuals with compromised kidney and/or heart function. Furthermore, the company is in the early stages of developing RDX020, which targets metabolic acidosis, a serious electrolyte disorder frequently seen in CKD patients. To broaden the reach of tenapanor, Ardelyx has established strategic partnerships with Kyowa Kirin in Japan, Fosun Pharmaceutical Industrial Development Co. Ltd. in China, and Knight Therapeutics, Inc. in Canada, granting them rights for the drug's development and commercialization in their respective regions. Originally incorporated in 2007 as Nteryx, Inc., the company adopted its current name, Ardelyx, Inc., in June 2008. Its headquarters are located in Waltham, Massachusetts.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Ardelyx, Inc. logo

Ardelyx, Inc.

NASDAQ:ARDXHealthcare
-2.26%$3.03
AH$3.03+0.00%vs close
Mkt Cap$782.31M
Float243.16M
O/S258.19M
Vol
$ Vol
RVOL
Inst Own68.7%
SI12.4%
Earnings
Dilution
Ardelyx, Inc. logoNASDAQ:ARDX$3.03-2.26%
Phase Distribution
29 lead-sponsored trials·2 active·26 completed
Phase 110
Phase 27
Phase 2/32
Phase 38
Phase 42
(3 more as collaborator)
Status Overview
Recruiting2
Completed26
Stopped1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

    Tenapanor, Sevelamer Carbonate

    Hyperphosphatemia, End Stage Renal Disease

    Enrollment
    172
    Start
    Jun 2019
    Primary Completion
    Jun 2021
    Completion
    Jul 2021
    NCT03988920
  • Phase 4
    Completed

    Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

    Tenapanor

    Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia

    Enrollment
    333
    Start
    Nov 2020
    Primary Completion
    Oct 2021
    Completion
    Dec 2021
    NCT04549597
  • Phase 3
    Completed

    A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

    Tenapanor, Placebo

    Constipation Predominant Irritable Bowel Syndrome

    Enrollment
    606
    Start
    Oct 2015
    Primary Completion
    Mar 2017
    Completion
    Apr 2017
    NCT02621892
  • Phase 3
    Completed

    An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

    Tenapanor, Placebo

    Hyperphosphatemia

    Enrollment
    219
    Start
    Jan 2016
    Primary Completion
    Dec 2016
    Completion
    Jan 2018
    NCT02675998
  • Phase 3
    Completed

    A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

    Tenapanor, Placebo

    Constipation Predominant Irritable Bowel Syndrome

    Enrollment
    593
    Start
    Dec 2015
    Primary Completion
    Aug 2017
    Completion
    Oct 2017
    NCT02686138
  • Phase 3
    Completed

    A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

    Tenapanor

    Constipation Predominant Irritable Bowel Syndrome

    Enrollment
    312
    Start
    Mar 2016
    Primary Completion
    Oct 2017
    Completion
    Oct 2017
    NCT02727751
  • Phase 3
    Completed

    A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

    Tenapanor, Placebo

    Hyperphosphatemia

    Enrollment
    1,559
    Start
    Jan 2018
    Primary Completion
    Nov 2019
    Completion
    Feb 2020
    NCT03427125
  • Phase 3
    Completed

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

    Tenapanor 50 MG, Tenapanor 25 mg bid

    Irritable Bowel Syndrome With Constipation (IBS-C)

    Enrollment
    180
    Start
    Nov 2022
    Primary Completion
    Aug 2026
    Completion
    Aug 2026
    NCT05643534
  • Phase 3
    Enrolling by invitation

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

    Tenapanor

    Irritable Bowel Syndrome With Constipation (IBS-C)

    Enrollment
    150
    Start
    Feb 2023
    Primary Completion
    Jul 2031est.
    Completion
    Oct 2031est.
    NCT05905926
  • Phase 3
    Recruiting

    A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

    Tenapanor 5 mg BID, Tenapanor 25 mg BID

    Chronic Idiopathic Constipation (CIC)

    Enrollment
    692
    Start
    Jan 2026
    Primary Completion
    Feb 2027est.
    Completion
    Jun 2027est.
    NCT07382167
  • Phase 2/3
    Completed

    The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)

    AZD1722, Placebo

    Constipation Predominant Irritable Bowel Syndrome

    Enrollment
    356
    Start
    Aug 2013
    Primary Completion
    Oct 2014
    Completion
    Oct 2014
    NCT01923428
  • Phase 2/3
    Completed

    Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

    Tenapanor, Placebo

    Hyperphosphatemia

    Enrollment
    236
    Start
    Feb 2019
    Primary Completion
    Jul 2019
    Completion
    Jul 2019
    NCT03824587
  • Phase 2
    Completed

    A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

    RDX5791

    Constipation Predominant Irritable Bowel Syndrome

    Enrollment
    186
    Start
    May 2011
    Primary Completion
    Dec 2011
    Completion
    Feb 2012
    NCT01340053
  • Phase 2
    Completed

    Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis

    AZD1722 (in-patient), Placebo (in-patient)

    End Stage Renal Disease, Chronic Kidney Disease Stage 5 +1

    Enrollment
    88
    Start
    Jan 2013
    Primary Completion
    Oct 2013
    Completion
    Oct 2013
    NCT01764854
  • Phase 2
    Completed

    A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

    AZD1722, Placebo

    Chronic Kidney Disease, Type 2 Diabetes Mellitus

    Enrollment
    154
    Start
    May 2013
    Primary Completion
    Mar 2015
    Completion
    Apr 2015
    NCT01847092
  • Phase 2
    Completed

    Dose Finding Study to Treat High Phosphate Levels in the Blood.

    AZD1722, Placebo

    Hyperphosphatemia

    Enrollment
    162
    Start
    Mar 2014
    Primary Completion
    Nov 2014
    Completion
    Nov 2014
    NCT02081534
  • Phase 2
    Terminated

    A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia

    RDX227675, Placebo

    Hyperkalemia

    Enrollment
    60
    Start
    Jan 2017
    Primary Completion
    May 2017
    Completion
    May 2017
    NCT03018067
  • Phase 2
    Completed

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

    RDX013, Placebo

    Hyperkalemia

    Enrollment
    109
    Start
    Jan 2021
    Primary Completion
    Dec 2021
    Completion
    Mar 2022
    NCT04780841
  • Phase 2
    Completed

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

    Tenapanor, Placebo

    Irritable Bowel Syndrome With Constipation (IBS-C)

    Enrollment
    72
    Start
    Jul 2024
    Primary Completion
    Jul 2026
    Completion
    Jul 2026
    NCT06553547
  • Phase 1
    Completed

    AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

    AZD1722

    Healthy Volunteers

    Enrollment
    26
    Start
    Apr 2014
    Primary Completion
    May 2014
    Completion
    May 2014
    NCT02063386
  • Phase 1
    Completed

    To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

    Midazolam, AZD1722

    Healthy Volunteers

    Enrollment
    65
    Start
    May 2014
    Primary Completion
    Aug 2014
    Completion
    Aug 2014
    NCT02140268
  • Phase 1
    Completed

    To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers

    Treatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil

    Healthy Volunteers

    Enrollment
    71
    Start
    May 2014
    Primary Completion
    Aug 2014
    Completion
    Aug 2014
    NCT02140281
  • Phase 1
    Completed

    Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

    AZD1722, Placebo

    Healthy Volunteer

    Enrollment
    83
    Start
    Jul 2013
    Primary Completion
    Dec 2013
    Completion
    Dec 2013
    NCT02176252
  • Phase 1
    Completed

    D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects

    AZD1722 salt tablet, AZD1722 free base tablet

    Healthy Volunteers Food Interaction Study

    Enrollment
    37
    Start
    Mar 2013
    Primary Completion
    Oct 2013
    Completion
    Oct 2013
    NCT02226783
  • Phase 1
    Completed

    A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations

    AZD1722, Omeprazole

    Healthy

    Enrollment
    18
    Start
    Feb 2013
    Primary Completion
    Feb 2013
    Completion
    Feb 2013
    NCT02249936

1-25 of 29

Search ClinicalTrials.gov for “Ardelyx”