Ibsrela (tenapanor) / Ardelyx, Kyowa Kirin, Fosun Pharma, Knight Therap - LARVOL DELTA

Real-World Safety Analysis of the Constipation-Predominant IBS Treatment Options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk. (clinicaltrials.gov) - P4 | N=18 | Completed | Sponsor: University of Texas Southwestern Medical Center | Recruiting ➔ Completed

Trial completion • Nephrology • Renal Calculi

Tenapanor Improves Abdominal Bloating Symptoms in Patients With IBS-C Experiencing Moderate-to-Severe Bloating. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal

Efficacy and Safety of Tenapanor in IBS-C: A Systematic Review and Meta-Analysis. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • Retrospective data

Reduction in Gastrointestinal Visits and Portal Messaging Following Tenapanor Initiation in Patients in Community Gastrointestinal Practices. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults (clinicaltrials.gov) - P3 | N=692 | Recruiting | Sponsor: Ardelyx

New P3 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis. (PubMed, Therap Adv Gastroenterol) - P2/3, P3 | "This novel post hoc analysis demonstrates that, compared with placebo, tenapanor reduces the time to first response in CSBM frequency and abdominal symptoms and consistently increases the weekly response rate during 12 weeks of treatment. NCT01923428; NCT02621892; NCT02686138."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Treatment Satisfaction With Tenapanor: Real-World Survey of Patients With IBS-C. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • Real-world evidence

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Ardelyx | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Mechanism of reduced intestinal phosphate absorption by tenapanor: a hypothesis. (PubMed, Clin Kidney J) - "This hypothesis aligns with prior findings that tenapanor does not alter the expression of tight junction proteins, suggesting a physicochemical rather than a structural basis for reduced permeability. Further investigations are warranted to determine whether the electrostatic properties of the paracellular pathway contribute to the phosphate-lowering effect of tenapanor."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Renal Disease

Assessing the Efficacy and Safety of Multiple Drugs for IBS-C: A Systematic Review and Network Meta-Analysis. (PubMed, J Gastrointestin Liver Dis) - "For patients with IBS-C, higher doses of linaclotide and tenapanor may provide enhanced symptom relief, but caution is warranted regarding their safety profiles."

Clinical • Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Pharmacotherapy for Chronic Idiopathic Constipation and Constipation-Predominant Irritable Bowel Syndrome Beyond Conventional Laxatives: A Narrative Review. (PubMed, Cureus) - "Secretagogues like linaclotide improve both motility and sensory symptoms, which are often poorly managed by conventional laxatives...Future therapies are expected to better address the distinct yet overlapping features of these disorders, providing patient-specific treatment, improving symptom relief, and enhancing overall quality of life. The insights synthesized in this review may enhance our understanding of the mechanisms behind pharmacotherapy for chronic constipation and support their application in clinical practice to better patient outcomes."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation (clinicaltrials.gov) - P4 | N=30 | Active, not recruiting | Sponsor: Kyle Staller, MD, MPH | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of tenapanor in the management of irritable bowel syndrome with constipation: a systematic review and meta-analysis. (PubMed, Eur J Gastroenterol Hepatol) - "Tenapanor is effective in improving IBS-C symptoms but has a higher incidence of treatment-related AEs. Further studies are needed to evaluate its long-term safety."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Cost-Effectiveness Analysis of Tenapanor in Japanese Patients with Hyperphosphatemia on Hemodialysis (KIDNEY WEEK 2025) - "Group A included patients who were controlled with phosphate binders (PBs) and in whom Tenapanor was compared with ferric citrate. Table 1. Base-case analysis ICER: Incremental cost-effectiveness ratio, JPY: Japanese yen, PBs: Phosphate binders, QALY: Quality-adjusted life year."

Clinical • Cost effectiveness • HEOR • Metabolic Disorders • Nephrology • Renal Disease

Comparative Phosphate-Lowering Effects of Tenapanor in Combination with Different Phosphate Binders in Patients on Hemodialysis: A Prospective Pilot Study (KIDNEY WEEK 2025) - "Methods In this prospective study, 55 HD patients were stratified into five groups based on their baseline phosphate binder (PB) use: PB-naïve, calcium-based binders, iron-based binders (ferric citrate), lanthanum carbonate, and polymer-based binders. Although the exact mechanism remains unclear, it is hypothesized that iron-based binders such as ferric citrate may alter intestinal pH—potentially affecting the local action of tenapanor. These preliminary results highlight the importance of binder selection in maximizing tenapanor efficacy and warrant further mechanistic and clinical studies."

Clinical • Combination therapy • Cardiovascular • Metabolic Disorders • Nephrology • Renal Disease

Treatment Satisfaction with Tenapanor (XPHOZAH): Real-World Survey of Patients with ESRD and Hyperphosphatemia (KIDNEY WEEK 2025) - "Patient survey results. TEN, tenapanor."

Clinical • Real-world • Real-world evidence • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Tenapanor Improves Bowel Movements in Patients with ESKD and Mild to Severe Constipation (KIDNEY WEEK 2025) - P3 | "No unexpected safety signals were observed in this study. Conclusion Improved weekly stool frequency and stool consistency were observed in pts with ESKD who experienced constipation at baseline and were taking TEN to reduce serum phosphate."

Clinical • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Nephrology • Renal Disease

Role of Tenapanor in the Management of Hyperphosphatemia in Patients with Kidney Failure (KF) Undergoing Peritoneal Dialysis (PD): Real-World Experience from a Single Center (KIDNEY WEEK 2025) - "Over half of eligible patients were unable to initiate or continue therapy, mainly due to diarrhea. Larger, multicenter studies with longer follow-up are needed to further explore the safety and efficacy of tenapanor’s role in phosphate control for PD patients."

Clinical • Real-world • Real-world evidence • Cardiovascular • Metabolic Disorders • Nephrology • Renal Disease

Real-World Effectiveness of Tenapanor (XPHOZAH) for Treatment of Hyperphosphatemia in Patients on Dialysis in the United States (KIDNEY WEEK 2025) - "These findings support the real-world effectiveness of tenapanor for management of serum phosphate in patients with end stage kidney disease and hyperphosphatemia. P, phosphate."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

ALK5 Inhibition Improves Transport and Respiration in Primary Renal Proximal Tubule Cells at One Year in Culture (KIDNEY WEEK 2025) - "Methods Primary human renal proximal tubule cells (Lonza, Basel) were seeded at 10^5 cells per cm^2 on permeable supports and grown in 50:50 DMEM/F12 with ITS, hydrocortisone, T3, and ascorbic acid in humidified 5% CO2/Air...1 week after confluence, media was supplemented with metformin, SB431542, or both...Transport was inhibitable with tenapanor but not furosemide or hydrochlorothiazide...This suggests that prolonged function of a tubule cell bioreactor for cell therapy is feasible. Further investigation of the mechanisms by which ALK5 inhibition improves cell function are warranted."

Renal Disease • TGFB1 • TGFBR1

Real-World Safety Analysis of the Constipation-Predominant Irritable Bowel Syndrome Treatment Options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor (ACG 2025) - "Linaclotide was suspected of frequently inducing diarrhea (n=2,082, 24.1%), abdominal pain (n=815, 9.4%), abdominal bloating (n=795, 9.2%), and nausea/vomiting (n=266, 3.1%). Plecanatide was suspected of frequently inducing diarrhea (n=137, 20.4%), abdominal pain (n=76, 11.3%), abdominal bloating (n=62, 9.2%), and nausea/vomiting (n=34, 5.1%). Tenapanor was suspected of frequently inducing diarrhea (n=51, 32.9%), abdominal pain (n=13, 8.4%), and abdominal bloating and nausea/vomiting (n=11 each, 7.1%)."

Clinical • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Pulmonary Disease

Treatment Satisfaction with Tenapanor (IBSRELA): Real-World Survey of Patients With Irritable Bowel Syndrome With Constipation (ACG 2025) - "Of the 4252 invites sent, 537 patients completed the survey. As shown in the Figure, most patients reported treatment satisfaction with TEN (88%) as well as improved constipation (95%), bloating (75%), and abdominal pain (84%). All 3 symptoms improved in 69% of patients."

Clinical • Real-world • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and Safety of Tenapanor in Irritable Bowel Syndrome With Constipation (IBS-C): A Systematic Review and Meta-Analysis (ACG 2025) - "Three RCTs were included in the analysis. Tenapanor significantly improved several symptoms in patients with IBS-C compared to placebo. It demonstrated higher response rates for abdominal bloating (RR = 1.32, 95% CI: [1.15, 1.51], p < 0.01), cramping (RR = 1.27, 95% CI: [1.13, 1.44], p < 0.01), discomfort (RR = 1.37, 95% CI: [1.21, 1.56], p < 0.01), fullness (RR = 1.37, 95% CI: [1.20, 1.58], p < 0.01), pain (RR = 1.37, 95% CI: [1.17, 1.49], p < 0.01), and complete spontaneous bowel movements (CSBM) (RR = 1.54, 95% CI: [1.24, 1.91], p < 0.01)."

Retrospective data • Review • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder

New Kid on the Block: Could Suzetrigine's Promise of Pain Relief Improve Outcomes in Management of DGBI? (ACG 2025) - "He tried linaclotide, plecanatide, lubiprostone, prucalopride, and tenapanor...Adjunct pharmacological neuromodulators like nortriptyline, duloxetine and gabapentin were not helpful...She responded partially to duloxetine, buspirone, mirtazapine, and cognitive behavioral therapy...Studies have directly and indirectly established the importance of NaV1.8 to visceral pain perception (Table 1). Additional trials are needed to evaluate the impact of this medicine on visceral pain perception especially in conditions associated with acute and/or chronic abdominal pain, including DGBIs.Figure: Summary of Studies Supporting the Role of Nav1.8 in Visceral Pain Perception"

Cardiovascular • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Mood Disorders • Novel Coronavirus Disease • Pain • Psychiatry • NAV1