Amitiza (lubiprostone) / Takeda, Mallinckrodt - LARVOL DELTA

Combined Efficacy of Methylnaltrexone and Naloxegol in Managing a Case of Neurogenic and Opioid-Induced Constipation (ACG 2025) - "His bowel regimen is polyethylene glycol 17g 3 times a day, lubiprostone 24mcg daily, 2 tablet of senna 8.6mg twice daily, and naloxegol 12.5mg daily. (2020), which show methylnaltrexone's efficacy in opioid-treated patients. While promising, further research is needed to assess the long-term safety and efficacy of this combined approach in similar patient populations."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Multiple Sclerosis

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

Rectal Bleeding as the Initial Presentation of Prostate Adenocarcinoma With Direct Rectal Invasion: A Case Report (ACG 2025) - "Current treatment includes both radiation therapy and hormonal therapy with lubiprostone. This case highlights the need to consider prostate cancer with rectal invasion as a potential cause in elderly male patients presenting with rectal bleeding and rectal masses that appear atypical for primary colorectal...A multidisciplinary approach is essential for effective management.Figure: Prostate mass directly invading the rectumFigure: A. Hematoxylin and Eosin, 400XB. Prostate specific antigen immunization (Ventana, Roche, Tucson, Arizona), 400X"

Case report • Clinical • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ACPP • CDX2 • PSAP

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

Chronic Constipation and Small Bowel Obstruction as a Complication of Uterine Fibroids (ACG 2025) - "Trials of lubiprostone and linaclotide did not provide relief. UAE was successfully performed, leading to symptomatic relief and resolution of the obstruction without the need for surgical resection. This case underscores the importance of considering pelvic pathology in the differential diagnosis of bowel obstruction and chronic constipation in women and demonstrates the utility of UAE as a minimally invasive, fertility-sparing therapeutic option in select patients.Figure: Uterine Fibroids Causing Sigmoid NarrowingFigure: CT Coronal View Uterine Fibroids"

Constipation • Gastroenterology • Gastrointestinal Disorder • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

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

Lubiprostone in chronic kidney disease: Insights into mitochondrial function and polyamines from a randomized phase 2 clinical trial. (PubMed, Sci Adv) - "Multiomics analysis revealed that lubiprostone modulated the gut microbial agmatine pathway and increased spermidine levels, thereby improving renal mitochondrial function. Lubiprostone is a previously unknown and safe therapeutic option to mitigate renal decline in CKD."

Clinical • Journal • P2 data • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Nephrology • Renal Disease

Effect of magnetically guided capsule endoscopy on gastrointestinal transit time and diagnostic yield: a systematic review and meta-analysis. (PubMed, BMC Gastroenterol) - "No single intervention optimizes all CE parameters. Erythromycin and magnetic control are effective for rapid gastric transit, while lubiprostone and PEG expedite small bowel transit. To maximize the likelihood of a complete examination, metoclopramide is a well-supported option. These findings allow clinicians to select a tailored pre-procedural strategy based on the specific goals of the CE examination."

Journal • Retrospective data

Regulatory effects of 2'-FL combined with Lactobacillus plantarum on the microbiome-gut-brain axis in constipation-type depression (ACS-Fall 2025) - "Currently,Veruquestra, Lubiprostone, and Linaclotide are commonly used to alleviate constipation, but prolonged use may cause dependence, resistance, and significant side effects...By assessing intestinal transit rate, time to first black stool, various behavioral tests, serum inflammatory factors, brain neurotransmitter levels, gut microbiota composition, and related protein expression in loperamide-induced constipated and depressed mice, the results indicated that the combined treatment with high-dose 2'-FL and Lactobacillus plantarum 1.0642 significantly reduced serum levels of TNF-α, IL-1β, and IL-6 compared to other groups (P < 0.05), increased 5-HT, NE, BDNF, 5-HIAA, and DA levels, and reduced GABA levels (P < 0.05). Analysis via 16S rDNA gene sequencing, this combined treatment promoted the abundance of SCFAs producing bacteria, including Bacteroides, Bifidobacterium, Murella and Roseburia. Western blot analysis demonstrated that 2'-FL and L...."

IO biomarker • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Mood Disorders • Psychiatry • BCL2 • IL1B • IL6 • TNFA

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

Seoul Consensus on Clinical Practice Guidelines for Functional Constipation (PubMed, Korean J Gastroenterol) - "The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding management. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding managing functional constipation."

Clinical guideline • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Comparative Effectiveness of Lubiprostone and Stool Softeners on Risk of Kidney Outcomes in Patients with Chronic Kidney Disease. (PubMed, Clin J Am Soc Nephrol) - "Incident lubiprostone (vs. stool softener) use was independently associated with lower risk of progressive kidney function decline in patients with CKD and constipation. Further studies are needed to refine the comparative effectiveness of different laxative types on kidney outcomes in clinical trials."

HEOR • Journal • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Nephrology • Renal Disease

Performance, Efficacy, and Safety of Lubiprostone in Bowel Preparation Regimens: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, J Clin Gastroenterol) - "Lubiprostone as an adjunct agent for bowel prep improves the odds of excellent quality prep while mitigating the odds of poor prep. Lubiprostone adjunct bowel prep is similar to control in adverse effects."

Journal • Retrospective data

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

Radical Hydro-Ethoxycarbonyldifluoromethylation of Alkenes with BrCF2CO2Et. (PubMed, Chemistry) - "The difluoromethylene (CF₂) group, valued for its unique electronic and steric properties, plays a critical role in pharmaceutical and agrochemical design, as exemplified by drugs like Lubiprostone, which requires ethyl 2,2-difluorohexanoate as a key intermediate for its synthesis...This process is applicable to both unactivated alkyl alkenes and active aryl alkenes. The protocol is characterized by mild reaction conditions, the absence of expensive reagents, and the elimination of transition metals."

Journal

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

Evaluation of post-market adverse events of lubiprostone: a real-world adverse event analysis from the FAERS database. (PubMed, BMC Gastroenterol) - "Our study comprehensively evaluated the safety of lubiprostone in the post-marketing setting. Despite its therapeutic advantages, there is a potential for various systemic adverse effects. In addition to adverse events consistent with information from existing clinical trials and the insert, we discovered several serious localized adverse reactions and previously unreported systemic adverse reactions. These may be potentially associated with lubiprostone, but are not confirmed adverse effects. This will provide valuable evidence for future studies and further prospective clinical trials to confirm these results and elucidate the relationship between them, thus better guiding the clinical practice of lubiprostone."

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

ANALYSES OF THE SOCIOECONOMIC VALUES OF TREATMENTS FOR CHRONIC CONSTIPATION IN JAPAN (DDW 2025) - "Methods Using data from clinical trials of Lubiprostone, Linaclotide, and Elobixibat conducted in Japan, changes in the number of spontaneous bowel movements (SBM) were synthesized using network meta-analysis (NMA), with placebo results set at zero for comparison. Sensitivity Analysis: The results were sensitive to the effectiveness of Elobixibat, but the trend remained consistent with the base case analysis for the other costs. Conclusions When selecting constipation treatment drugs, it is essential to consider not only their efficacy and cost but also their potential to reduce the socioeconomic burden associated with chronic constipation."

Constipation • Gastroenterology • 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

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

Assessment of Lubiprostone as an Adjunct Therapy for Bowel Preparation in Colonoscopy: A Meta-Analysis of Randomized Controlled Trials. (PubMed, JGH Open) - "It also did not affect procedure time [MD = -0.74, 95% CI: -2.91-1.43; p = 0.50], polyp detection rate [RR = 1.07, 95% CI: 0.90-1.26; p = 0.45], or adenoma detection rate [RR = 1.09, 95% CI: 0.75-1.57; p = 0.66]. Our meta-analysis found that LBP, explored as an adjunct to PEG-E solutions for bowel preparation, offers no significant additive effect on preparation quality before colonoscopy."

Journal • Retrospective data • Review • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation (PubMed, Korean J Gastroenterol) - "Guanylate cyclase-C agonists (linaclotide and plecanatide) enhance intestinal fluid secretion and motility, normalize bowel movements, and reduce abdominal pain. Na+/H+ exchanger inhibitors (e.g., tenapanor) decrease sodium absorption, increase fluid secretion, and alleviate visceral pain. Lubiprostone activates the chloride channels to facilitate bowel movements, while polyethylene glycol laxatives regulate osmotic pressure to improve stool consistency and ease defecation. Highly selective 5-HT4 agonists, such as prucalopride, accelerate gastrointestinal and colonic transit and improve stool frequency and consistency without increasing the cardiovascular risks raised in earlier agents such as tegaserod...These pharmacology agents have shown efficacy and safety in clinical studies, but drug availability, adverse effects, and variable patient responses are still challenging. Effective strategies to manage IBS-C require a personalized approach, considering the..."

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

Evaluation study on the effectiveness and safety of Lubiprostone combined with magnesium sulfate in bowel preparation for elderly patients with constipation (ChiCTR) - P=N/A | N=100 | Recruiting | Sponsor: Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center

New trial • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of a polyethylene glycol electrolyte solution combined with lubiprostone for bowel preparation in type 2 diabetes patients using GLP-1 receptor agonists: a prospective, multicenter, randomized, open-label, blinded endpoint trial (ChiCTR) - P=N/A | N=216 | Not yet recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus