Linzess (linaclotide) / AstraZeneca, Astellas, Ironwood Pharma, AbbVie - LARVOL DELTA

The effects of combined use of linaclotide and oral sulfate solution in bowel preparation for chronic constipation patients undergoing colonoscopy (ChiCTR) - P4 | N=195 | Not yet recruiting | Sponsor: Beijing Shijitan Hospital, Capital Medical University; Beijing Shijitan Hospital, Capital Medical University

New P4 trial • Constipation • Gastroenterology • Gastrointestinal Disorder

A Study on the Application of Linaclotide Combined with Polyethylene Glycol for Bowel Preparation Before Colonoscopy in Patients with Risk Factors for Inadequate Bowel Preparation (ChiCTR) - P=N/A | N=320 | Not yet recruiting | Sponsor: Liaoning Provincial People's Hospital; Liaoning Provincial People's Hospital

New trial • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders

IBSC-VR: A Study of Virtual Reality and Linaclotide for IBS-C (clinicaltrials.gov) - P=N/A | N=65 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

Healthcare Utilization and Costs of Care in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation After Initiating Oral Therapies: Real-World Analysis in the US Medicare Population. (PubMed, Adv Ther) - "These findings suggest that linaclotide treatment may be associated with lower total healthcare costs compared to lubiprostone and plecanatide for patients initiating IBS-C/CIC-related drugs in Medicare populations."

HEOR • Journal • Medicare • Real-world evidence • Reimbursement • US reimbursement • Constipation • Gastroenterology • Gastrointestinal Disorder

Linaclotide As a SingleAgent Bowel Preparation Regimen Before Colonoscopy. (ASCRS 2025) - "The procedure was well tolerated without complications.Conclusion/ Our experience demonstrates the potential application of linaclotide as a well-tolerated, single-agent bowel preparation regimen prior to colonoscopy that warrants further study. A randomized, controlled trial is planned to further investigate a single-agent linaclotide versus traditional PEG-based bowel preparation regimen."

Constipation • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Obesity • Pain

Linaclotide for Bowel Preparation: Is "Afterload Reduction" Not Just for Heart Failure Anymore? (PubMed, Am J Gastroenterol) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial. (PubMed, J Gastroenterol Hepatol) - P4 | "Linaclotide shows better efficacy for functional dyspepsia and constipation-predominant irritable bowel syndrome overlap compared with lactulose."

Journal • Constipation • Dyspepsia • Gastroenterology • Gastrointestinal Disorder

EFFICACY OF LINACLOTIDE AS A BOWEL CLEANSING AGENT IN PATIENTS WITH CHRONIC CONSTIPATION: A SEVERITY-BASED ANALYSIS OF THE APPLE TRIAL (DDW 2025) - No abstract available

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

EFFICACY AND SAFETY OF LINACLOTIDE IN TREATING PEDIATRIC PATIENTS AGED 7–17 YEARS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C): RESULTS FROM A PHASE 3 STUDY (DDW 2025) - No abstract available

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

COMPARATIVE EFFICACY AND SAFETY OF LINACLOTIDE AND POLYETHYLENE GLYCOL COMBINATIONS FOR COLONOSCOPY BOWEL PREPARATION: A NETWORK META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. (DDW 2025) - No abstract available

Retrospective data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

LINACLOTIDE COMBINED WITH POLYETHYLENE GLYCOL FOR BOWEL PREPARATION IN OUTPATIENT COLONOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (DDW 2025) - No abstract available

Retrospective data • Review

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) - No abstract available

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

LONG-TERM SAFETY OF LINACLOTIDE IN TREATING PEDIATRIC PATIENTS AGED 7–17 YEARS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C): INTERIM RESULTS FROM A PHASE 3 STUDY (DDW 2025) - No abstract available

Clinical • P3 data • P3 data: top line • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

ADDING LINACLOTIDE TO 1-L PEG-ASC REGIMEN: EFFICACY ACROSS AGE GROUPS IN A SUBGROUP ANALYSIS OF THE APPLE TRIAL (DDW 2025) - No abstract available

Clinical

Efficacy of 1 L polyethylene glycol plus ascorbic acid with linaclotide versus senna for bowel preparation: A multicenter, endoscopist-blinded, randomized controlled trial (Apple trial). (PubMed, Am J Gastroenterol) - "The linaclotide regimen was superior to the senna regimen in terms of BP efficacy without reducing tolerability. It can be a promising new option for BP, especially in patients at a high-risk of inadequate BP."

Journal

The structural integrity of human TFF1 under reducing conditions. (PubMed, Redox Biol) - "Experiments revealed high resistance of the disulfide bonds within the TFF1 domain to reduction compared to two reference peptides with similar three-disulfide frameworks, namely the bovine pancreatic trypsin inhibitor (BPTI) and the peptide drug linaclotide...These molecular simulations explained why TFF1 could not be partially reduced and alkylated during the experiments despite titrating different TCEP concentrations in the presence of alkylating agents. Our findings provide the first insights into the remarkable stability of the human TFF domain under reducing conditions, supporting its functional resilience upon expression and secretion throughout the human body."

Journal • Gastrointestinal Disorder • TFF1 • TFF3

Partially differentiated enterocytes in ileal and distal-colonic human F508del-CF-enteroids secrete fluid in response to forskolin and linaclotide. (PubMed, bioRxiv) - "Also, linaclotide and a general PDE inhibitor independently enhanced combined CFTR-modulator-induced FIS response from partially differentiated F508del-CF enteroids. These findings demonstrate that partially differentiated ileal and distal colonic F508del-CFTR enteroids can be stimulated to secrete fluid by cAMP and cGMP."

Journal • Constipation • Cystic Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • CFTR

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database. (PubMed, Expert Opin Drug Saf) - "We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone."

Adverse events • Journal • P4 data • Real-world evidence • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Comparison chart: Safety of drugs for IBS in pregnancy and lactation. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastrointestinal Disorder

Drugs for irritable bowel syndrome. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Figure 1: Treatments for irritable bowel syndrome (IBS) in adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Comparison chart: Some drugs for irritable bowel syndrome with constipation (IBS-C). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Real-world safety of linaclotide in Chinese patients with irritable bowel syndrome with constipation: a multicenter, single-arm, prospective observational study. (PubMed, Therap Adv Gastroenterol) - "In the Chinese real-world setting, linaclotide was safe and well tolerated in patients with IBS-C. Numerically, there are trends toward improvement in PROs with linaclotide treatment."

Journal • Observational data • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Impact of Weight on the Efficacy, Time to Response, and Safety of Linaclotide in Adults With Chronic Idiopathic Constipation or Irritable Bowel Syndrome With Constipation: Post Hoc Descriptive Analysis by Body Mass Index. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (clinicaltrials.gov) - P3 | N=123 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics