Trulance (plecanatide) / Bausch Health - LARVOL DELTA

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

Outpatient Management of Partial Small Bowel Obstruction Using an Oral Palatable Elemental Diet (ACG 2025) - "Given her prior postoperative complications, she has been understandably hesitant to undergo surgical lysis of adhesions.Episodes of pSBO would occur despite multiple gut-directed treatments including lubiprostone, linaclotide, plecanatide, pyridostigmine, and rifaximin daily. Elemental diets provide complete nutrition with high absorptive efficiency in the proximal small bowel. Being fiber- and residue-free, they present an intriguing option for the conservative management of partial bowel obstruction.Figure: Figure 1) Serial abdominal radiographs demonstrating the progression and resolution of partial small bowel obstruction in response to outpatient exclusive elemental diet consumption in 2024.Figure: Figure 2) Serial abdominal radiographs demonstrating the progression and resolution of partial small bowel obstruction in response to outpatient elemental diet consumption in 2025."

Clinical

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

Efficacy and safety of pharmacological therapies for functional constipation in children: a systematic review and meta-analysis. (PubMed, Lancet Child Adolesc Health) - "Polyethylene glycol is probably more effective than placebo and key comparator therapies and should be considered the standard of first-line care. Future studies should consider polyethylene glycol as an index therapy, and clearly describe methods, patient characteristics, and previous therapeutics."

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

Based on the FDA Adverse Event Reporting System Database, a Study on Signal Mining of Adverse Events for Guanylate Cyclase-C Receptor Agonists. (PubMed, Hosp Pharm) - "To analyze and evaluate adverse drug event (ADE) signals for two GC-C receptor agonists, Linaclotide and Plecanatide, thereby enhancing understanding of their clinical safety. Clinical utilization of GC-C receptor agonists should take into account not only the prevalent gastrointestinal ADEs but also emerging signals associated with the urinary system, metabolic and nutritional disorders, and the nervous system. A comprehensive understanding of these signals is essential for evaluating medication risks and ensuring appropriate drug administration."

Adverse events • Journal • CNS Disorders • Pain • Sleep Disorder

Laxative logic: when lifestyle is not enough. (PubMed, Curr Opin Gastroenterol) - "Patients with constipation now have access to a wide range of medications, from over-the-counter osmotic and stimulant agents to prescription laxative combination strategies. This breadth allows clinicians to tailor therapy to diverse pathophysiology and symptom profiles. Yet despite this choice, real-world adherence remains poor and many patients are dissatisfied, reflecting the complexity of treating constipation and frequent mismatches between therapy and patients' most bothersome symptoms. Management should emphasize careful symptom assessment, shared decision-making, and clear expectation setting, while leveraging the available armamentarium."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C) (clinicaltrials.gov) - P2 | N=218 | Completed | Sponsor: Bausch Health Americas, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Nov 2024 | Trial primary completion date: Dec 2023 ➔ Oct 2024

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

A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on food and drug administration adverse event reporting system. (PubMed, Front Pharmacol) - "This study identifies a significant association between linaclotide/plecanatide and muscle spasms. The findings highlight the need for vigilance in high-risk populations and call for further investigation into the underlying mechanisms."

Adverse events • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Current Treatment Options for Children with Functional Constipation-What Is in the Pipeline? (PubMed, Children (Basel)) - "New agents such as lubiprostone, prucalopride, linaclotide, and plecanatide have demonstrated improved outcomes compared to placebo or conventional therapies, particularly in increasing spontaneous bowel movements. Therapy-resistant FC in children is a complex and impactful condition. An individualized, stepwise approach is essential, with surgical options such as colonic resection reserved as a last resort."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Adding a C-terminal amino acid prevents the conformational interconversion of plecanatide analogues. (PubMed, Chembiochem) - "The principle of structure dictating properties is illustrated by the direct correlation between cyclic peptide conformation and their biological efficacy. Plecanatide, a synthetic analogue of uroguanylin, has received FDA approval for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Nevertheless, our investigation has revealed that plecanatide undergoes slow conformational interconversion in slightly acidic conditions. In response, we strategically incorporated propargylglycine at the carboxyl terminal of plecanatide, a modification that not only facilitates additional functionalization and derivatization but also confers exceptional conformational stability. Remarkably, the resulting isomers not only maintained long-term conformational stability but also exhibited either preserved or slightly enhanced agonistic activity. This discovery represents a contribution to drug..."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and Safety of Plecanatide in Chinese Patients with Functional Constipation: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, Drugs) - "Plecanatide 3 mg was effective and well tolerated in the treatment of Chinese patients with FC. A weekly CSBM response at week 2 may serve as a predictor of 12-week durable overall efficacy. Patients who did not achieve the primary endpoint may still benefit from plecanatide treatment."

Clinical • Journal • P3 data • Constipation • Gastroenterology • Gastrointestinal Disorder

PROVISIONAL EXPERT RECOMMENDATIONS FOR THE MANAGEMENT OF FECAL INCONTINENCE IN SYSTEMIC SCLEROSIS: A REPORT FROM WORLD SCLERODERMA FOUNDATION (WSF) GASTROINTESTINAL "AD HOC COMMITTEE" (EULAR 2025) - "(100%) Consider and prioritize pelvic physical therapy upfront for SSc-FI attributable to pelvic floor weakness before testing, as patients often improve and risk is minimal (if any) (100%) If overflow diarrhea is the issue and slow colonic transit is present, consider a trial of prokinetics (e.g., prucalopride or pyridostigmine). (83.3%) If slow colonic transit is not an issue, consider a trial of other medications (e.g., secretagogues, such as linaclotide, lubiprostone, plecanatide) to help alleviate stool burden... We present provisional recommendations for the evaluation and management of fecal incontinence in SSc. Only minimal refinement and voting is required to finalize these practical recommendations. Our collegiate approach will provide guidance for clinical practice and also inform a future research agenda."

Gastroenterology • Immunology • Rheumatology • Scleroderma • Systemic Sclerosis

Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, plecanatide, and Tenapanor: analysis of the FDA adverse event reporting system (FAERS) database. (PubMed, Expert Opin Drug Saf) - "This post-marketing analysis of the FAERS database revealed diarrhea, abdominal pain, bloating, and nausea/vomiting were the most frequently reported AEs across all medications. Novel findings include the potential for clinically significant dehydration from Linaclotide-induced diarrhea and Lubiprostone-associated dyspnea and chest pain."

Adverse events • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain • Pulmonary Disease

The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. (PubMed, Am J Gastroenterol) - "Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation due to an AE when compared to rifaximin, the safest pharmacotherapy studied."

Journal • Retrospective data • Gastrointestinal Disorder

THE CLINICAL EFFICACY OF LINACLOTIDE AND PLECANATIDE IN IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C) AND CHRONIC IDIOPATHIC CONSTIPATION (CIC): A POTENTIAL BENEFIT TO SWITCHING GUANYLATE CYCLASE C (GCC) AGONISTS? (DDW 2025) - "GCC agonist switch strategies in the setting of patients' non-response or intolerance to initial regimens may yield improvements in global CIC/IBS-C symptoms. This observation does not appear to be associated with DGBI diagnosis or baseline symptom severity. Further prospective study in larger, more diverse populations is needed to better understand the potential benefits of GCC switch approaches to bowel disorders."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Mood Disorders • Pain • Psychiatry

GCC Agonist Signal in the Small Intestine (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2025

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

EVALUATING THE SAFETY OF PHARMACOTHERAPY FOR IRRITABLE BOWEL SYNDROME: A META-ANALYSIS (DDW 2025) - "AEs were more varied for tricyclics (indicated for IBS global symptoms); for example, compared to placebo the three most common AEs with associated risk increases were drowsiness (14%), dry mouth (12%), and weight gain (9%) for amitriptyline, dry mouth (22%), flushing (18%), and constipation (17%) for desipramine, and fatigue (15%), dry mouth (3%) and blurry vision (1.5%) for doxepin...The NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor (indicated for IBS-C) was 27 (p < 0.01), 53 (p = 0.59), 58 (p < 0.01), 59 (p = 0.03), and 17 (p <0.01) respectively. The NNH for alosetron and eluxadoline (indicated for IBS-D) was 16 (p < 0.01) and 32 (p < 0.01). Ramosetron and rifaximin (indicated for IBS-D) had a negative risk difference, with the rate of withdrawal due to AEs higher in the placebo arm, so NNH was a negative, although statistically insignificant, value... Tricyclics, alosetron, and tenapanor are associated with a higher..."

Retrospective data • Constipation • Fatigue • Gastrointestinal Disorder • Xerostomia

IBS-C PATIENT EXPERIENCES WITH PHARMACOLOGIC THERAPIES: QUALITATIVE ANALYSIS OF ONLINE POSTS FROM (TWITTER) AND E-HEALTH FORUMS (DDW 2025) - "To find relevant posts from IBS-specific subforums, we applied filters targeting FDA-approved IBS-C medications (linaclotide, lubiprostone, plecanatide, tegaserod, tenapanor). Discussions : Our study highlights the diverse real-world experiences of IBS-C patients with FDA-approved therapies, revealing variability in both efficacy and the biopsychosocial impacts associated with each medication. These findings highlight the importance of shared decision making in selecting an IBS-C treatment, including evaluating the need to switch medications or classes, as well as addressing barriers such as cost and side effects to improve adherence and patient outcomes."

Clinical • CNS Disorders • Constipation • Gastrointestinal Disorder • Mood Disorders • Psychiatry

GCC Agonist Signal in the Small Intestine (clinicaltrials.gov) - P1 | N=43 | Active, not recruiting | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Barrett Esophagus • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology

Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology. (PubMed, Therapie) - "Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment."

Adverse events • Journal • Dermatology

EFFICACY AND SAFETY OF PLECANATIDE IN CHINESE PATIENTS WITH FUNCTIONAL CONSTIPATION: A PHASE 3 RANDOMIZED DOUBLW-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL (DDW 2025) - "Plecanatide 3 mg was effective and safety for treating Chinese patients with FC. Weekly CSBM response at week 2 may predict 12-week durable overall efficacy. Patients did not reach primary endpoints can still benefit from plecanatide treatment."

Clinical • P3 data • Constipation • Gastroenterology • Gastrointestinal Disorder