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

Effect of linaclotide combined with polyethylene glycol on bowel preparation before colonoscopy in patients with constipation. (PubMed, Front Med (Lausanne)) - P4 | "http://www.chictr.org.cn (registration no. ChiCTR2400083515)."

Clinical • 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

Exploring the Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation and IBS-C: A Meta-Analysis of Randomized Control Trials. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

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

Linaclotide for Colonoscopy Bowel Prep (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: University of Florida | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Enrollment open • Trial completion date • Trial primary completion date

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 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

Identification and Quantification of Structurally Related Peptide Impurity in Linaclotide by Liquid Chromatography-High Resolution Mass Spectrometry. (PubMed, Rapid Commun Mass Spectrom) - "The developed LC-HRMS method successfully addresses the challenge of determining structurally related peptide impurities in linaclotide. Its ability to characterize specific impurities provides a valuable complement to existing quality control strategies for peptide therapeutics."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

What Good Can One Session Do? Exploring the Effectiveness of Family Systemic Constellation Therapy in Individual Sessions (ANZCTR) - P=N/A | N=35 | Recruiting | Sponsor: Diane Rogers, PhD, Core Insights Institute | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2025

Enrollment open • Trial initiation date • CNS Disorders • Depression • Mood Disorders • Psychiatry

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 Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study. (PubMed, Neurogastroenterol Motil) - "In healthy controls, acute administration of linaclotide increases the total number of long-distance propagating sequences and the pre-prandial pancolonic pressurizations."

Journal • Colorectal Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder

UNITY VCS Vitreoretinal Surgery (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Alcon Research | N=260 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cataract • Diabetic Retinopathy • Hematological Disorders • Retinal Disorders

Differential segment-specific signalling pathways for guanylate cyclase C-activated anion secretion in murine ileocolon. (PubMed, Br J Pharmacol) - "GC-C activation leads to CFTR-mediated ASR in all segments of the intestine. In the mid and distal colon ASR is strongly reduced by the low cGKII and high PDE9 expression, with the CFTR channel being activated via cAMP-mediated phosphorylation."

Journal • Preclinical • Colorectal Cancer • Oncology • Solid Tumor

Image-guided therapy of colorectal cancer using a zirconium coordinated nanosensitizer. (PubMed, J Nanobiotechnology) - "In this study, a tumor-targeting nanosonosensitizer, Zr-HMME-PEG-Linaclotide (HP-LNC), was designed by coordinating the sonosensitizer hematoporphyrin monomethyl ether (HMME) with zirconium (Zr) to form a Zr-HMME complex...PET and fluorescence imaging results revealed efficient accumulation of HP-LNC at the tumor site, excellent in vivo stability for HP-LNC, and effective monitoring of therapeutic progress. Overall, this nanoplatform successfully integrates dual-modal imaging with ROS-mediated therapy, highlighting its substantial potential in multimodal cancer treatment, particularly for colorectal cancer therapy."

Journal • Colorectal Cancer • Oncology • Solid Tumor • CALR • HMGB1

Bali Chronic Constipation Roundtable Report: Chronic Constipation Management in Asia. (PubMed, J Neurogastroenterol Motil) - "First line therapies such as dietary-fiber optimization and osmotic laxatives are widely available, but newer pharmacotherapies (prucalopride, linaclotide, lubiprostone, and elobixibat) remain costly and unevenly accessible. The Bali Chronic Constipation Roundtable highlighted Asia's need for region specific diagnostics and management. Addressing diagnostic and treatment gaps will improve outcomes, while ongoing researcher clinician policy collaboration must standardize guidelines, advance research, and ensure equitable care across Asia."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

CTV678-H003: Surgical Procedure Efficiency Evaluation stuDy (clinicaltrials.gov) - P=N/A | N=180 | Not yet recruiting | Sponsor: Alcon Research

New trial • Real-world evidence • Cataract • Hematological Disorders • Ophthalmology • Retinal Disorders

Oxalate nephropathy precipitated by linaclotide in a high-risk patient. (PubMed, Clin Nephrol Case Stud) - "Linaclotide can contribute to ON in predisposed patients. Clinicians should consider medication history and risk factors in unexplained AKI and pursuing kidney biopsy for diagnosis."

Journal • Acute Kidney Injury • Chronic Kidney Disease • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Nephrology • Pain • Renal Disease

The membrane excitability properties of GUCY2C-high neuropod cells in the gut-brain axis (Neuroscience 2025) - "Overall, these results demonstrate that GUCY2C-high NPCs display neuron-like excitability and the expected Na and K membrane conductance. Supporting the importance of GUCY2C-high NPCs' membrane excitability, preliminary experiments also showed the optogenetic hyperpolarization of the GUCY2C-high NPCs membrane potential with archaerhodopsin recapitulates the silencing effect of linaclotide on DRG neurons."

CNS Disorders • GUCY2C

Linaclotide in combination with compound polyethylene glycol powder enhances bowel preparation for colonoscopy in patients aged over 60 years: a multi-center, endoscopist-blind, randomized controlled trial. (PubMed, Scand J Gastroenterol) - "The bowel preparation efficacy of Lina + 2 L-PEG is comparable to that of 3 L-PEG, yet superior to that of 2 L-PEG. Moreover, Lina + 2 L-PEG is associated with fewer adverse reactions, a lower cost, and a higher willingness to repeat the colonoscopy among patients aged over 60 years."

Journal

Safety and efficacy of linaclotide as an adjuvant for bowel preparation: A systematic review and meta-analysis. (PubMed, Arab J Gastroenterol) - "Linaclotide demonstrates superior efficacy compared to the control group with equal PEG doses and shows no statistically significant difference when compared to the group with double the PEG dosage, all while resulting in fewer adverse events."

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

U.S. Food and Drug Administration (FDA) approved the company’s Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). (Investing.com) - "The FDA’s decision was supported by efficacy data extrapolated from adult studies and a 12-week clinical trial in pediatric patients aged 7 to 17 years."

FDA approval • Constipation • Gastrointestinal Disorder

Effect of linaclotide combined with Simethicone and polyethylene glycol electrolyte powder on cleansing effect of bowel in patients with constipation (ChiCTR) - P=N/A | N=390 | Completed | Sponsor: The People's Hospital of Jianyang City; The People's Hospital of Jianyang City

New trial • 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

Linaclotide's Time to Response for Chronic Idiopathic Constipation Symptom Relief: A Post Hoc Analysis of Randomized Controlled Studies (ACG 2025) - P3, P3b | "Overall, 2400 patients were included: LIN 72 µg, n = 411, mean age: 45.8 years, female: 75.9%; LIN 145 µg, n = 994, 47.5 years, 84.3%; PBO, n = 995, 46.7 years, 85.4%. Median (95% CI) time to achieving ≥ 3 CSBMs/week was 11 (8, 12) and 5 (4, 6) weeks for patients treated with LIN 72 µg and 145 µg, respectively (not reached [NR] for PBO; Figure). Median time to first SBM after initial dose of LIN (72 µg or 145 µg) was 2 days vs 3 days with PBO."

Clinical • 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

Comparing Safety and Efficacy of Different Bowel Preparation Regimens in Constipated Patients Undergoing Colonoscopy: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials (ACG 2025) - "Fifteen RCTs were included in this network meta-analysis. Compared to 4L PEG (polyethylene glycol), 3L PEG + 3d-Lin (3 days-Linaclotide) (RR=1.29; 95%CI:[1.12,1.47], p=0.0002), 4L PEG + 1d-Lin (RR=1.25; 95%CI:[1.04,1.51], p=0.02), NaP (sodium phosphate) + bisacodyl (RR=1.52; 95%CI:[1.09,2.10], p=0.01) and Probiotic 14d + NaP (RR= 3.59; 95%CI:[1.83,7.04], p=0.0002) arms significantly increased the adequate bowel preparation with Probiotic 14d + NaP group ranked highest and Senna + MgSO4 (Magnesium sulphate) ranked lowest regarding this outcome. The risk of all other adverse effects, including nausea, vomiting, and bloating, was comparable between different regimens, except abdominal pain, which was significantly reduced in the 3L PEG + 3d-Lin arm (RR=0.18; 95%CI:[0.04,0.88], p=0.03) compared to 4L PEG. In constipated patients, Probiotic 14d + NaP showed the highest efficacy for adequate bowel preparation, while Senna + MgSO4 was least effective."

Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder