Trulance (plecanatide) / Bausch Health - LARVOL DELTA

First Reported Case of MRI Performed on a Patient With Multiple Vibrant Vibrating Capsules In Situ (ACG 2026) - "She experienced ineffective responses or side-effects to multiple pharmacologic therapies including polyethylene glycol, senna, bisacodyl (oral and rectal), glycerin suppositories, magnesium salts, linaclotide, plecanatide, lubiprostone, prucalopride, and tenapanor. This report also highlights the need for improved screening for ingestible electronic devices prior to MRI. Figure: X-ray Showing 5 Vibrant Vibrating Capsules In Situ 1 Day After MRI"

Clinical • Constipation • Endocrine Disorders • Fibromyalgia • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics

Comparative Real-World Safety of Linaclotide, Plecanatide, and Lubiprostone: Risks of AKI and Hemodynamic Events (ACG 2026) - "After matching, 40,131 linaclotide-plecanatide and 115,091 linaclotide-lubiprostone pairs were identified. Compared with plecanatide, linaclotide users had higher 30-day risks of AKI (0.47% vs 0.24%; RR 1.95, 95% CI 1.53-2.49, p< 0.0001), volume depletion (0.53% vs 0.40%; RR 1.32, 95% CI 1.07-1.61, p=0.008), hypotension (0.70% vs 0.59%; RR 1.20, 95% CI 1.01-1.42, p=0.04), and diarrhea (1.32% vs 1.04%; RR 1.27, 95% CI 1.11-1.44, p=0.0003). When compared with lubiprostone, linaclotide users experienced lower risks of AKI (0.59% vs 0.74%; RR 0.80, 95% CI 0.73-0.89, p< 0.0001), volume depletion (0.61% vs 0.76%; RR 0.81, 95% CI 0.73-0.89, p< 0.0001), and hypotension (0.83% vs 0.95%; RR 0.88, 95% CI 0.80-0.95, p=0.002), with similar rates of diarrhea (1.30% vs 1.30%; RR 1.00, 95% CI 0.93-1.07, p=0.94)."

Clinical • Real-world • Real-world evidence • Acute Kidney Injury • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatology • Hypotension • Nephrology • Renal Disease

Adjunctive Use of Vibrating Capsule for Refractory Constipation in Autosomal Dominant Polycystic Kidney Disease With Severe Organomegaly (ACG 2026) - "He had failed or inadequately responded to lactulose, polyethylene glycol, magnesium citrate, bisacodyl, senna, mineral oil, enemas, suppositories, lubiprostone, prucalopride, fiber, linaclotide alone, plecanatide alone, and pelvic floor physical therapy. Figure: Figure 1b. Sagittal T2-weighted MRI demonstrates renomegaly along with stool-filled colon."

Autism Spectrum Disorder • Autosomal Dominant Polycystic Kidney Disease • Chronic Kidney Disease • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy • Nephrology • Pancreatic Cancer • Polycystic Kidney Disease • Renal Disease

Pan-Enteric Dysmotility and Small Bowel Malabsorption: A Multidisciplinary Challenge in a Patient With LADA and Hashimoto's (ACG 2026) - "Despite extensive medical therapy which included prokinetics (prucalopride, erythromycin, azithromycin) , intestinal secretagogues (lubiprostone, plecanatide), antiemetics (ondansetron, prochlorperazine) and antispasmodics (dicyclomine), (proton pump inhibitors and H2 blockers), symptoms persisted . An integrated neuro-immuno-gastroenterological approach is essential in such complex presentations. Figure: Smallbowel Figure: Autoimmune"

Clinical • Constipation • Crohn's disease • Diabetes • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Secondary Hyperparathyroidism • IL13 • IL6

Early Physiologic Motility Testing Versus Empiric Medical Management in IBS-C: A Propensity-Matched Real-World Analysis (ACG 2026) - "Cohort 2 received empiric management (lubiprostone, linaclotide, plecanatide, tegaserod, lactulose, or PEG 3350) without motility testing. Cohorts were well-balanced post-matching (83.5% female each). Functional symptom persistence was similar (74.9% vs. 77.3%; RR 0.97, 95% CI 0.90â1.05; p=0.42; HR 0.88, 95% CI 0.76â1.03; log-rank p=0.12)."

Clinical • Real-world • Real-world evidence • CNS Disorders • Colorectal Cancer • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Mood Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Plecanatide for Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation: A Systematic Review and Network Meta-Analysis (ACG 2026) - "Our review included six clinical trials and seven post-hoc studies with 8841 patients, with 6652 (75.24%) CIC patients and 2189 (24.76%) IBS-C patients. Only clinical trials were included in our network meta-analysis. Our analysis showed that compared with placebo, plecanatide 3 mg/day could significantly relieve continuous spontaneous bowel movement (CSBM) per week (MD 0.99, 95% CI 0.61 to 1.37; p < 0.0001), stool consistenecy (MD 0.61, 95% CI 0.49 to 0.74; p < 0.0001) and constipation severity (MD â0.30, 95% CI â0.41 to â0.20; p < 0.0001; P-score = 0.86)."

Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder

Pharmacotherapy of Irritable Bowel Syndrome with Constipation in Children: An Update on Clinical Progress and Successes. (PubMed, Drugs) - "Particular attention is given to newer agents approved for adults with irritable bowel syndrome with constipation, including secretagogues (linaclotide, plecanatide, and lubiprostone) and the retainagogue tenapanor, with a detailed discussion of their pharmacological properties and clinical trial data. While other novel agents have shown promise in adults, pediatric data remain limited or unavailable. Overall, although pharmacological treatment options for pediatric irritable bowel syndrome with constipation are expanding, high-quality, pediatric specific clinical trials are still needed to guide safe and effective management."

Journal • Review • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain • Pediatrics

Patients' Real-World Experiences With Pharmacologic Therapies for Irritable Bowel Syndrome With Constipation: A Mixed-Methods Analysis and Classification of Social Media and E-Forum Posts. (PubMed, Neurogastroenterol Motil) - "Social media provides unique insights into IBS-C patients' real-world experiences with FDA-approved therapies. Findings highlight variability in efficacy, biopsychosocial impacts, and adherence challenges, underscoring the need for shared decision making and proactive management of barriers to optimize outcomes."

Journal • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Mood Disorders • Psychiatry

Trulance: This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Bausch Health Americas, Inc.

New P2 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

Constipation with bloating: a clinical approach to evaluation and management. (PubMed, Ann Med) - "Management approaches discussed include dietary modification, biofeedback, and pharmacologic therapy, including over-the-counter treatments, plecanatide, linaclotide, lubiprostone, tenapanor, neuromodulators, and antibiotics. There is a need for additional research to further understand the physiology of bloating. In an era when personalized medicine is becoming increasingly emphasized, understanding the pathophysiology of bloating for an individual patient, be it alongside constipation or other GI and non-GI symptoms, will be paramount to improve treatment outcomes."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder

Irritable Bowel Syndrome with Constipation: Diagnosis and Multisymptom Management Beyond Abdominal Pain and Bowel Movement Frequency: A Review. (PubMed, Adv Ther) - "Several medications are indicated for IBS-C, including secretagogues such as guanylate cyclase C agonists (plecanatide, linaclotide) and chloride channel activators (lubiprostone [women only]), as well as sodium/hydrogen exchanger 3 (NHE3) inhibitors (tenapanor). An integrated approach to treatment of IBS-C, particularly in patients with persistent symptoms after treatment with first-line secretagogues or NHE3 inhibitors, may include neuromodulators, appropriate antibiotic regimens in those with intestinal methanogen overgrowth (IMO), and/or nonpharmacologic approaches including dietary interventions and brain-gut behavioral therapies. Effective treatment plans for IBS-C should target the most bothersome symptoms, including a collaborative discussion of risks/benefits of various treatments, culminating in an agreement on a path forward between the patient and healthcare provider."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

A targeted partial reduction Cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in Disulfide rich cyclic peptides. (PubMed, J Chromatogr A) - "Notably, it enables reliable differentiation of disulfide isomers that are otherwise indistinguishable using routine analytical techniques. Overall, this study establishes a practical and robust method for disulfide bond mapping in cyclic peptides, with broad applicability for structural characterization and quality assessment and don't require enzymatic digestion or specialized instrumentation.The methodology was successfully validated using Linaclotide, Plecanatide, and Ziconotide, which contain three, two, and three disulfide bridges, respectively."

Journal

Efficacy and safety of Guanylyl cyclase C agonists (linaclotide and plecanatide) in patients with irritable bowel syndrome with constipation: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Front Pharmacol) - "Their efficacy and safety should be carefully weighed when used clinically. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251168079, Identifier CRD420251168079."

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

GCC Agonist Signal in the Small Intestine (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: University of Wisconsin, Madison | Active, not recruiting ➔ Completed

Trial completion • Barrett Esophagus • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology

Reconsidering Bloating as a Core Endpoint in IBS-C: Commentary on Brenner et al. (2025). (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

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

Reconsidering Multisymptom Composite Endpoints in IBS-C Trials. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal

Improvement in Health-Related Quality of Life in Adults With IBS-C Not Achieving Bowel Movement Frequency Criterion: Analysis of Two Phase 3 Plecanatide Trials. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

HEOR • Journal • P3 data

Plecanatide Is Efficacious in Women Aged 18 to 40 Years With IBS-C and Bloating: A Pooled Analysis of Two Phase 3, Randomized, Placebo-Controlled Trials. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • P3 data • Retrospective data

Efficacy and tolerability of plecanatide for irritable bowel syndrome with constipation and chronic idiopathic constipation: a systematic review and meta-analysis. (PubMed, Eur J Gastroenterol Hepatol) - "In conclusion, plecanatide significantly improves bowel symptoms in CIC and IBS-C patients. None of the adverse events showed significant treatment differences except diarrhea, which showed a fourfold higher risk in the plecanatide group."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. (PubMed, J Gastroenterol Hepatol) - P3 | "Plecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Improvement in Health-Related Quality of Life (HR-QOL) in Adults With Irritable Bowel Syndrome With Constipation (IBS-C) Not Achieving Bowel Movement Frequency Criterion: Analysis of Two Phase 3 Plecanatide Trials (ACG 2025) - "928 patients (plecanatide [n = 428; 72.0% female]; placebo [n = 500; 74.0% female]) were included. Mean (SD) age in the plecanatide vs placebo groups was 43.4 (14.0) vs 43.3 (14.2), and mean IBS-QOL score was 47.4 (25.6) vs 45.8 (24.7). Baseline mean score was 6.5 vs 6.4 for abdominal pain, and mean number of CSBMs/week was 0.2 for both groups."

Clinical • HEOR • P3 data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder

Sustained Efficacy and Tolerability of Vibrant Capsule Therapy in a 77-Year-Old Female With Chronic Constipation: A 24-Month Case Study (ACG 2025) - "Previous treatments included linaclotide, plecanatide, and magnesium-based products, which provided only partial relief and were associated with adverse effects including bloating and diarrhea. The patient reported sustained symptom relief, reduced treatment burden, and high satisfaction over 24 months of use. Vibrant may offer a well-tolerated, non-pharmacologic alternative in elderly patients with refractory constipation.Figure: Patient Assessment (Table 1)Figure: The Vibrant System (Fig 1)"

Case study • Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

Plecanatide Is Efficacious in Women With Irritable Bowel Syndrome with Constipation (IBS-C) and Bloating: A Pooled Analysis of Two Phase 3, Randomized, Placebo-Controlled Trials (ACG 2025) - "651 females (median age, 31.0 y) with IBS-C and bloating (71.3% moderate/severe) were included (plecanatide 3 mg [n = 220]; 6 mg [n = 218]; placebo [n = 213]). Plecanatide 3 mg, 6 mg, and placebo group baseline mean symptom scores were 6.2, 6.3, and 6.4 for abdominal pain and 6.4, 6.5, and 6.7 for bloating, and the mean number of CSBMs/wk were 0.2, 0.3, and 0.2. Overall, a statistically significantly greater percentage of patients treated with plecanatide 3 mg or 6 mg vs placebo were trisymptom composite responders, defined using several stringent thresholds (Figure)."

P3 data • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

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