Ibsrela

(Tenapanor)

ApprovedSmall molecule

AArdelyx

Ibsrela is one of 83 small molecule programs targeting Constipation. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cystic FibrosisActive, not recruiting

Irritable Bowel SyndromeCompleted

Pediatric PatientsEnrolling by invitation

HyperoxaluriaCompleted

Cystic FibrosisPhase 3

Active, not recruiting

Irritable Bowel SyndromeApproved

Completed

Pediatric PatientsPhase 3

Enrolling by invitation

HyperoxaluriaApproved

Completed

Competition

Competitive Landscape

105 competitors in Cystic Fibrosis

#DrugCompanyPhaseTrials

Ibsrela

AArdelyx

Approved

1 2

Biaxin

AbbVie

Phase 2

2 3

Mycobutin

Pfizer

Phase 2

1 4

HSK31858

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

2 5

Tygacil

PPrism Pharmaceuticals

Phase 2

1 6

Amoxil

GGlobal Antibiotics Research and Development Partnership

Phase 2

1 7

ELX/TEZ/IVA

Vertex Pharmaceuticals

Phase 3

19 8

Trikafta

NNottingham University Hospitals NHS Trust

Phase 3

4 9

VNZ/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

1 10

VX-121/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Constipation

NCT06460038

Q2 2027

Phase 3Recruiting

Constipation

NCT07382167

Phase 3Active, not recruiting

Cystic Fibrosis

NCT06810167

Q4 2027

Not yet recruiting

Hyperphosphatemia

NCT07882017

Clinical

Trials by Indication[1]

Hyperphosphatemia4 trials

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

Completed·AArdelyx·Phase 3·NCT02675998·219 enrolled

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

Completed·AArdelyx·Phase 3·NCT03427125·1,559 enrolled

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

Completed·AArdelyx·Phase 4·NCT04549597·333 enrolled

Show 1 more trial

Evaluation of the Real-World Efficacy of Tenapanor and Its Effects on Intestinal Metabolism in Patients Undergoing Maintenance Hemodialysis

Not yet recruiting·HHuashan Hospital··NCT07882017·70 enrolled

Efficacy and Safety2 trials

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

Completed·AArdelyx·Phase 3·NCT02621892·606 enrolled

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

Completed·AArdelyx·Phase 3·NCT02686138·593 enrolled

Constipation2 trials

Tenapanor in Synucleinopathy-Related Constipation

Recruiting·—·Phase 2·NCT06460038·30 enrolled

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

Recruiting·AArdelyx·Phase 3·NCT07382167·692 enrolled

Irritable Bowel Syndrome With Constipation (IBS-C)2 trials

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old

Completed·AArdelyx·Phase 3·NCT05643534·180 enrolled

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

Completed·AArdelyx·Phase 2·NCT06553547·72 enrolled

Dialysis1 trial

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

Completed·AArdelyx·Phase 4·NCT03988920·172 enrolled

7 more indications

Treatment1 trial

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

Completed·AArdelyx·Phase 3·NCT02727751·312 enrolled

Efficacy1 trial

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

Completed·AArdelyx·Phase 2/3·NCT03824587·236 enrolled

Irritable Bowel Syndrome1 trial

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Completed·—·Phase 4·NCT05995899·36 enrolled

Breast1 trial

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

Completed·AArdelyx·Phase 1·NCT06203444·7 enrolled

Pediatric Patients1 trial

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

Enrolling by invitation·AArdelyx·Phase 3·NCT05905926·150 enrolled

Hyperoxaluria1 trial

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Completed·UUniversity of Texas Southwestern Medical Center·Approved·NCT06481150·18 enrolled

Cystic Fibrosis1 trial

An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.

Active, not recruiting·MMassachusetts General Hospital·Phase 3·NCT06810167·25 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 12, 2019

IBSRELA

NDA NDA211801

Sep 12, 2019

IBSRELA

NDA NDA211801

Mar 5, 2021

IBSRELA

NDA NDA211801

May 19, 2021

IBSRELA

NDA NDA211801

Apr 5, 2022

IBSRELA

NDA NDA211801

Oct 17, 2023

XPHOZAH

NDA NDA213931

Jan 10, 2025

IBSRELA

NDA NDA211801

May 20, 2025

IBSRELA

NDA NDA211801

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Tenapanor. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tenapanor compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tenapanor. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211801). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ibsrela. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Ardelyx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AArdelyx

Patent Landscape[5]

Patent Cliff

Dec 30, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8969377Dec 30, 2029

9408840Dec 30, 2029

12016856Dec 30, 2029

9006281May 2, 2030

8541448Aug 1, 2033

3 more patents

10272079Apr 10, 2034

10940146Apr 10, 2034

12539299Nov 26, 2042

Ibsrela

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Hyperphosphatemia4 trials

Efficacy and Safety2 trials

Constipation2 trials

Irritable Bowel Syndrome With Constipation (IBS-C)2 trials

Dialysis1 trial

Treatment1 trial

Efficacy1 trial

Irritable Bowel Syndrome1 trial

Breast1 trial

Pediatric Patients1 trial

Hyperoxaluria1 trial

Cystic Fibrosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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