Viberzi (eluxadoline) / AbbVie - LARVOL DELTA

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children (clinicaltrials.gov) - P2 | N=272 | Completed | Sponsor: AbbVie | Recruiting ➔ Completed | N=95 ➔ 272 | Trial completion date: Dec 2026 ➔ Aug 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Pediatrics

Association Between Opioid Exposure and Adverse Disease-Related Outcomes in Inflammatory Bowel Disease (ACG 2026) - "Patients receiving loperamide or eluxadoline were excluded. After propensity score matching, cohorts included 255,291 patients per group at 30 days, 244,959 patients per group at 90 days, and 254,925 patients per group at 1 year. Opioid exposure was associated with increased adverse disease-related outcomes across all time points. At 1 year, patients with opioid exposure had increased risk of IBD-related surgery compared with patients without opioid exposure (HR 3.24, 95% CI 2.83â3.71, p< 0.001)."

Addiction (Opioid and Alcohol) • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Mental Retardation • Obesity • Substance Abuse • Ulcerative Colitis

Drug-Induced Pancreatitis Associated With Chronic Eluxadoline Use in a Patient With an Intact Gallbladder and Atrophic Pancreas (ACG 2026) - "The patient further disclosed use of pancrelipase for pancreatic exocrine insufficiency, losartan-hydrochlorothiazide for hypertension, and chronic eluxadoline use for IBS-D. Contrast-enhanced CT abdomen imaging showing (A) initial findings of a slightly atrophic pancreas with peripancreatic inflammatory changes and no cholecystitis, cholelithiasis, or adrenal or renal mass. Repeat imaging 6 days later shows (B) an atrophic pancreas with moderate peripancreatic fluid and inflammatory stranding extending to the gastric margin."

Clinical • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hepatology • Hypertension • Hypertriglyceridemia • Immunology • Pancreatitis

A Case of Post-Infectious Diarrhea Predominant Irritable Bowel Syndrome Lasting Over a Decade Following Ciguatera Poisoning (ACG 2026) - "Over multiple years, the patient was treated with methscopolamine, dicyclomine, rifaximin, metronidazole, and selective serotonin reuptake inhibitors with marginal improvement. Seven years ago, he started taking eluxadoline (Viberzi) with some relief...Prevalence, Risk Factors, and Outcomes of Irritable Bowel Syndrome After Infectious Enteritis: A Systematic Review and Meta-analysis. Gastroenterology 2017;152:1042-1054.e1."

Clinical • Dyspepsia • Gastrointestinal Disorder

Association of pharmacotherapy with all-cause mortality among patients with irritable bowel syndrome. (PubMed, Commun Med (Lond)) - "These findings raise concerns regarding the safety of antidepressants and mu receptor agonists in IBS treatment and underscore the need for cautious prescribing and further research."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Safety and Efficacy of Eluxadoline for Irritable Bowel Syndrome (Diarrhea Predominant): Systematic Review and Meta-Analysis (ACG 2025) - "The review includes a total of 7 articles that assessed the efficacy of eluxadoline for Irritable Bowel Syndrome compared with the placebo group. There are 2929 in the intervention group (eluxadoline) and 2934 in the placebo group. The primary outcome assessed was the odds ratio of efficacy of the drug eluxadoline vs placebo for the treatment of IBS."

Retrospective data • Review • Gastrointestinal Disorder

GLP-1 Receptor Agonist Use for Reducing Symptom Burden and Medication Utilization in Non-Obese Women With IBS-D: A Propensity Matched Retrospective Cohort Study (ACG 2025) - "Two cohorts were identified: those prescribed GLP-1 RAs and those prescribed non-GLP IBS medications such as alosetron, eluxadoline, or loperamide. GLP-1 RA users had a significantly lower risk for abdominal pain (RR 0.56, CI 0.34-0.91, p= 0.014), and IBS agent use (RR 0.55, CI 0.35-0.85, p= 0.005). GLP-1 users had a lower risk for diarrhea (22% vs. 38%, RR 0.58, CI 0.31-1.08, p=0.08)."

Retrospective data • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Obesity

EFFICACY AND SAFETY OF ELUXADOLINE IN IRRITABLE BOWEL SYNDROME: A SYSTEMATIC REVIEW AND META-ANALYSIS (UEGW 2025) - "Although treatments like loperamide exist, many patients have challenges with symptom relief. Eluxadoline 100 mg improved stool consistency but was not significantly helpful in lowering abdominal pain as a single endpoint. Composite responder analysis showed a clinically meaningful but not statistically meaningful benefit. The safety profile was consistent with anticipated μ-opioid agonist effects, making patient selection of particular importance, particularly in those prioritizing diarrhea control over pain reduction."

Retrospective data • Review • Constipation • Gastrointestinal Disorder

Eluxadoline in Indian Patients With Diarrhoea-Predominant Irritable Bowel Syndrome: A Phase 3, Multicentre, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study [WITHDRAWN] (ACG 2025) - "Composite responder rate at week 12 was 41% (68/166) in Eluxadoline arm and 29.2% (49/168) in Mebeverine arm (p= 0.0238). Treatment difference between arms was 11.8% (1.6%, 22.0%) with lower limit of CI (1.6%) meeting the predefined non-inferiority margin of -12%. The composite responder rate at Week 4 & 8 were 12.0% & 20.5% in Eluxadoline arm and 7.1% & 18.5% in Mebeverine arm respectively."

Clinical • P3 data • Gastrointestinal Disorder

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P3 | N=124 | Enrolling by invitation | Sponsor: AbbVie | Trial completion date: Mar 2027 ➔ Dec 2032 | Trial primary completion date: Mar 2027 ➔ Dec 2032

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Pediatrics

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

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

DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME TREATMENT OPTIONS ELUXADOLINE, RIFAXIMIN, AND ALOSETRON: ANALYSIS OF THE FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) DATABASE (DDW 2025) - "Conclusion : Our analysis of the FAERS database showed frequent reports of abdominal pain, constipation, and nausea/vomiting related to the three FDA approved medications for IBS-D. Each raised concerns for distinct and serious AEs including pancreatitis (eluxadoline), C. difficile infection (rifaximin), ischemic colitis (alosetron), and intestinal obstruction/perforation (alosetron)."

Adverse events • Constipation • Gastrointestinal Disorder • Immunology • Infectious Disease • Pain • Pancreatitis

Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database. (PubMed, Expert Opin Drug Saf) - "Our analysis of the FAERS database showed frequentreports of abdominal pain, constipation, and nausea/vomiting related to thethree FDA approved medications for IBS-D. Each raised concerns for distinct andserious AEs including pancreatitis (eluxadoline), C. difficileinfection (rifaximin), ischemic colitis (alosetron), and intestinalobstruction/perforation (alosetron)."

Adverse events • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain • Pancreatitis

Visceral analgesic effect of eluxadoline (Viberzi): A central action. (PubMed, J Pharmacol Exp Ther) - "SIGNIFICANCE STATEMENT: The bifunctional opioid ligand eluxadoline is an FDA-approved drug for the treatment of diarrhea-predominant irritable bowel syndrome to normalize bowel movement and to relieve abdominal pain. This study documents for the first time to our knowledge that unlike its peripheral action to normalize diarrhea, the drug alleviates colon and bladder pain centrally by modulating responses of lumbo-sacral (L6-S1) spinal neurons."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Interstitial Cystitis • Pain • Psychiatry

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

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

Journal • 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

An evidence-based update on the diagnosis and management of irritable bowel syndrome. (PubMed, Expert Rev Gastroenterol Hepatol) - "Anti-diarrheal drugs should be used first-line for diarrhea, with second-line drugs including 5-hydroxytryptamine-3 antagonists, eluxadoline, or rifaximin, where available...Low-dose tricyclic antidepressants, such as amitriptyline, are preferred...Despite substantial advances, there remains scope for improvement in terms of both the diagnosis and management of IBS. Reinforcement of positive diagnostic strategies for the condition and novel treatment paradigms are required."

Journal • Review • Celiac Disease • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain

A Review of Pharmacologic and Non-Pharmacologic Therapies in the Management of Irritable Bowel Syndrome: Current Recommendations and Evidence. (PubMed, J Clin Med) - "In contrast, therapies like secretagogues for IBS-C and eluxadoline or rifaximin for IBS-D are subtype-specific. This review compares the latest IBS management guidelines from the American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), British Society of Gastroenterology (BSG), and European Society for Neurogastroenterology and Motility (ESNM). Pharmacologic and non-pharmacologic therapies, including established and emerging interventions, will be explored to provide a comprehensive guide to management."

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

Long-Term Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome (ACG 2024) - "Patient had not responded to loperamide, bismuth subsalicylate, fiber and probiotics...He was placed on cholestyramine, rifaximin, diphenoxylate/atropine, dicylomine, and anti-depressants which were ineffective. Eluxadoline was not tried due to his status post cholecystectomy...There is no standardized protocol for FMT such as pre-op preparation, dosing, method of delivery, anatomical sites to instill the donor stool, and follow up. Clinical trials with standardization of the FMT protocol for treating IBS are needed to achieve optimal outcomes."

Clinical • Celiac Disease • CNS Disorders • Crohn's disease • Depression • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Mood Disorders • Oncology • Pain • Psychiatry • Transplantation • Ulcerative Colitis • ELANE • GAST

Rifaximin and alternative agents in the management of irritable bowel syndrome: A comprehensive review. (PubMed, Arch Pharm (Weinheim)) - "Despite its promising efficacy and sustained symptom relief, further research is essential to optimize long-term effectiveness and dosing regimens. Rifaximin stands as a vital treatment option for IBS due to its distinctive properties and clinical utility; yet, ongoing investigation is imperative for maximizing its therapeutic benefits."

Journal • Review • Gastrointestinal Disorder • Pain

DIFFERENTIAL PATTERNS AND BENEFIT OF IBS-D MEDICATION USE IN SURGICALLY NAIVE PATIENTS WITH CROHN'S DISEASE AND ULCERATIVE COLITIS (DDW 2024) - "Methods : We used a multiyear prospective IBD natural history registry to identify patients with intact gastrointestinal anatomy who were prescribed medications typically used to treat IBS-diarrhea (IBS-D) including tricyclic (TCA) antidepressants bile acid sequestrants (BAS) µ-opioid receptor agonists (loperamide diphenoxylate-atropine and eluxadoline) and antispasmodics. In our tertiary cohort of surgery naïve IBD patients 3 % of CD and 0% of UC patients benefited from IBS-D medications aligning with the estimated one-third IBS and IBD overlap. CD patients had a higher IBS-D medication use and persistence compared with UC patients. Remarkably less than 1% of these patients had any disorders of gut-brain interaction (DGBI) listed in their charts."

Clinical • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis • CD70 • CD9 • ICAM1 • TFRC

Pharmacokinetic considerations for drugs that treat diarrhea-predominant irritable bowel syndrome: what's new? (PubMed, Expert Opin Drug Metab Toxicol) - "PubMed, Google Scholar and the USFDA databases were searched up to November 2023 to identify and include all updated information on eluxadoline, alosetron, and rifaximin. Therefore, healthcare providers may need to reduce the dosage for female patients to address this gender-specific issue. Integrating IBS care into sustainable development efforts can indirectly contribute to achieving SDGs and promote health and well-being for all."

Journal • PK/PD data • Review • Gastrointestinal Disorder • Metabolic Disorders