Trial reportClinical drug investigation2018
Pharmacodynamics, Safety, and Tolerability of the NHE3 Inhibitor Tenapanor: Two Trials in Healthy Volunteers.
Trial report in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Different Multiple Dose Regimens of RDX5791 in Healthy Volunteers
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of RDX5791 in Healthy Volunteers
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Efficacy and safety of tenapanor vs placebo in treating CKD patients on dialysis and with hyperphosphatemia: a systematic review and meta-analysis of 2251 patients.International urology and nephrology · 2025Pooled it
- Tenapanor Improves Abdominal Symptoms Irrespective of Changes in Complete Spontaneous Bowel Movement Frequency in Adults with Irritable Bowel Syndrome with Constipation.Digestive diseases (Basel, Switzerland) · 2025Trial
- Pharmacokinetics, Safety, and Tolerability of Tenapanor in Healthy Chinese and Caucasian Volunteers: A Randomized, Open-Label, Single-Center, Placebo-Controlled Phase 1 Study.International journal of clinical practice · 2024Trial
- Safety and Efficacy of Tenapanor for Long-term Serum Phosphate Control in Maintenance Dialysis: A 52-Week Randomized Phase 3 Trial (PHREEDOM).Kidney360 · 2021Trial
- Therapeutic Effects of Add-On Tenapanor for Hemodialysis Patients with Refractory Hyperphosphatemia.American journal of nephrology · 2021Trial
- Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).The American journal of gastroenterology · 2020Trial
- Efficacy and Safety of Tenapanor in Patients with Hyperphosphatemia Receiving Maintenance Hemodialysis: A Randomized Phase 3 Trial.Journal of the American Society of Nephrology : JASN · 2019Trial
- Efficacy of Tenapanor in Patients With or Without Prior Use of IBS-C Prescription Medications: A Post-hoc Analysis of Phase 3 Clinical Trials.Digestive diseases and sciences · 2026Article
- Tenapanor Beyond Phosphate: Gut Sodium Transport, Stool Transit Time, and Volume Balance in Dialysis Patients.Hemodialysis international. International Symposium on Home Hemodialysis · 2026Review
- Personalized Sequential Nephron Blockade for Diuretic Resistance in Acute Decompensated Heart Failure: A Narrative Review for the Cardiorenal Clinician.Journal of personalized medicine · 2026Review
- Pharmacological management of childhood constipation: Bridging today's gaps with tomorrow's therapies.World journal of clinical pediatrics · 2026Review
- Treatment Satisfaction with Tenapanor: Real-World Survey of Patients with End-Stage Renal Disease and Hyperphosphatemia.Patient preference and adherence · 2026Article
- Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis.Therapeutic advances in gastroenterology · 2026Article
- Mechanism of reduced intestinal phosphate absorption by tenapanor: a hypothesis.Clinical kidney journal · 2026Review
- Hyperphosphatemia in Kidney Failure: Pathophysiology, Challenges, and Critical Role of Phosphorus Management.Nutrients · 2025Review
- NHE3 inhibitor tenapanor maintains intestinal barrier function, decreases visceral hypersensitivity, and attenuates TRPV1 signaling in colonic sensory neurons.American journal of physiology. Gastrointestinal and liver physiology · 2024Article
- Neurogastroenterology and Motility Disorders of the Gastrointestinal Tract in Cystic Fibrosis.Current gastroenterology reports · 2024Review
- An Overview of the Effects of Tenapanor on Visceral Hypersensitivity in the Treatment of Irritable Bowel Syndrome with Constipation.Clinical and experimental gastroenterology · 2024Review
- Intestinal Permeability, Irritable Bowel Syndrome with Constipation, and the Role of Sodium-Hydrogen Exchanger Isoform 3 (NHE3).Clinical and experimental gastroenterology · 2024Review
- Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome with Constipation in the United States.Clinical and experimental gastroenterology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTenapanor, a small molecule with minimal systemic availability, is a first-in-class sodium/hydrogen exchanger 3 (NHE3) inhibitor that acts in the gut. Here, we evaluate the pharmacodynamics and safety of tenapanor in healthy adults.
methodsTwo phase I, single-center, randomized, double-blind, placebo-controlled studies were performed. The first study assessed single-ascending oral tenapanor doses of 10, 50, 150, 450, and 900 mg (n = 8 per group; six tenapanor, two placebo) and multiple ascending doses over 7 days of 3, 10, 30, and 100 mg q.d. (n = 10 per group; eight tenapanor, two placebo). In the second study, different tenapanor regimens were evaluated over 7 days (n = 15 per group; 12 tenapanor, three placebo): 15 mg twice daily (b.i.d.), 30 mg once daily (q.d.), 30 mg b.i.d., 30 mg three times daily (t.i.d.), 60 mg b.i.d., escalating b.i.d. dose (daily total 30-90 mg), 30 mg b.i.d. with psyllium.
resultsTenapanor produced generally dose-dependent increases in stool sodium excretion and decreases in urinary sodium excretion versus placebo; in addition, twice-daily dosing appeared to have a greater effect on sodium absorption than once-daily dosing with an equivalent daily dose. Tenapanor softened stool consistency and increased stool frequency and weight from baseline versus placebo. Tenapanor concentrations were below the quantification limit (0.5 ng/ml) in 98.5% of 895 plasma samples. Adverse events were mild or moderate in severity, and were typically gastrointestinal in nature. There were no clinically relevant changes in serum electrolytes.
conclusionsTenapanor was well tolerated and resulted in reduced intestinal sodium absorption and softer stool consistency versus placebo. Systemic exposure to tenapanor was minimal. These results support potential use of tenapanor in patients who could benefit from modification of gastrointestinal sodium balance. CLINICALTRIALS. GOV IDENTIFIERS: NCT02819687, NCT02796131.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.