A Review of Selected Presentations From the ACG 2025 Annual Scientific Meeting
October 24-29, 2025 • Phoenix, Arizona
Tenapanor Improves Abdominal Bloating Symptoms in Patients With IBS-C Experiencing Moderate-to-Severe Bloating
Abdominal bloating is a key symptom of irritable bowel syndrome with constipation (IBS-C) that has a significant influence on patient-reported outcomes, but is not included in the Rome IV diagnostic criteria.1,2 In 3 randomized trials, including a phase 2b trial and the phase 3 T3MPO-1 and T3MPO-2 trials, tenapanor 50 mg twice daily demonstrated improvements in abdominal symptoms over placebo.3-5 However, the effects of tenapanor on bloating have not been well defined.
At the American College of Gastroenterology’s 2025 Annual Scientific Meeting & Postgraduate Course (henceforth referred to as the ACG 2025 Annual Scientific Meeting), Staller and colleagues presented results of a post hoc analysis from these 3 trials evaluating the effects of 12 weeks of tenapanor on abdominal bloating in 1253 patients with moderate-to-severe bloating at baseline.6 Daily abdominal bloating was assessed via phone diaries, with symptoms rates on a scale of 0 to 10 and categorized as mild (0-3), moderate (4-7), or severe (8-10). Average weekly bloating scores were calculated for each week, with at least 4 days of abdominal bloating reported.
In the cohort of patients with moderate-to-severe bloating at baseline, the mean age was 45 years, 83% were female, 64% were White, and 31% were Black/African American, and the mean duration of IBS-C symptoms before randomization was 11.4 years.
The analysis found a consistent, significantly greater reduction in average weekly bloating score with tenapanor compared with placebo over the first 12 weeks (Figure 1). At week 12, the least-squares (LS) mean change in average weekly abdominal bloating score was -2.66 in the tenapanor arm and -2.10 in the placebo arm, for a LS mean difference of -0.57 (P=.0003).
The analysis also reported a faster improvement in bloating with tenapanor compared with placebo. By week 1, the cumulative probability of achieving a 30% or greater reduction in weekly bloating score was 18.0% with tenapanor vs 8.1% with placebo. This increased to 51.3% and 41.3%, respectively, at week 5, and 61.1% and 51.3%, respectively, at week 8.
The median time to onset of achieving a 30% or greater reduction from baseline in average weekly bloating score was 5 weeks with tenapanor vs 8 weeks with placebo (P<.0001). At week 12, improvements in average weekly bloating score of 50% or greater were achieved by 49.3% of patients in the tenapanor arm and 40.8% of patients in the placebo arm (P=.0007).
In the safety analysis, the incidence of study drug-related treatment-emergent adverse events (TEAEs) was 19.7% with tenapanor and 8.6% with placebo, and the incidence of serious TEAEs was 1.3% and 1.1%, respectively. The most frequent study drug-related TEAE associated with tenapanor was diarrhea, reported in 13.1% of patients, compared with 1.6% of patients receiving placebo.
Investigators cautioned that there are limitations with their analysis, including a lack of standardization of bloating severity assessment and unclear generalizability of this clinical trial population to real-world practice. However, they concluded that tenapanor may provide clinically meaningful reductions in bloating in patients with IBS-C that can be observed as soon as 1 week after starting treatment.
References
1. Neri L, Iovino P; Laxative Inadequate Relief Survey (LIRS) Group. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. Neurogastroenterol Motil. 2016;28(4):581-591.
2. Lacy BE, Mearin F, Chang L, et al. Bowel disorders. Gastroenterology. 2016;150:1393-1407.
3. Chey WD, Lembo AJ, Rosenbaum DP. Tenapanor treatment of patients with constipation-predominant irritable bowel syndrome: a phase 2, randomized, placebo-controlled efficacy and safety trial. Am J Gastroenterol. 2017;112(5):763-774.
4. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293.
5. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303.
6. Staller K, Yang Y, Zhao S, Edelstein S. Tenapanor improves abdominal bloating symptoms in patients with IBS-C experiencing moderate-to-severe bloating. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P0809.
Plecanatide Is Efficacious in Women Aged 18 to 40 Years With IBS-C and Bloating: A Pooled Analysis of Two Phase 3, Randomized, Placebo-Controlled Trials
Plecanatide is a guanylate cyclase-C agonist that is approved by the US Food and Drug Administration (FDA) for use in adults with chronic idiopathic constipation (CIC) or IBS-C.1 In 2 randomized, phase 3, placebo-controlled trials, plecanatide 3 mg (the FDA-approved dose) was associated with significant improvements in bowel movement frequency and other gastrointestinal symptoms in patients with IBS-C.1,2 In a post hoc analysis, the benefits of plecanatide also demonstrated benefit in patients with moderate-to-severe bloating at baseline.3
At the ACG 2025 Annual Scientific Meeting, Brenner and colleagues presented a post hoc analysis from these trials, reporting on the efficacy and safety of plecanatide in the subset of women aged 18 to 40 years with IBS-C and bloating, defined as a baseline bloating score of 1 or greater on a scale from 0 (no bloating) to 10 (worst possible bloating), and with a BMI of 18 to 40.4
The trials were identically designed, enrolling a total of 2189 adults with IBS-C who were randomly assigned to plecanatide 3 mg, plecanatide 6 mg, or placebo once daily for 12 weeks.3
The current analysis included 651 female adults with IBS-C with a median age of 31 years and with bloating that was moderate or severe at baseline in 71.3% of patients.4 Plecanatide administered at either 3 mg or 6 mg was associated with a significant improvement over placebo in the proportion of patients attaining a 3-variable composite response incorporating abdominal pain, bloating, and complete spontaneous bowel movements (CSBMs) per week.
The efficacy benefit with plecanatide over placebo was observed whether the threshold for improvement in pain and bloating was at least 2 points, at least 30%, or at least 40%, and whether the threshold for completeness of bowel movements was at least 1 or at least 2 CSBMs per week, with all 3 symptoms improving in the same week for at least 6 of 12 weeks.
In subgroup analyses, most composite endpoints remained significantly improved with plecanatide over placebo at both doses, regardless of baseline bloating intensity (Table 1).
The rate of AEs of any grade was 27.7% with plecanatide 3 mg, 22.5% with plecanatide 6 mg, and 18.3% with placebo. The most common AE was diarrhea, reported in 3.6% of patients receiving plecanatide 3 mg, 3.7% of patients receiving plecanatide 6 mg, and no patient receiving placebo. Diarrhea appeared to be more frequent in patients with moderate-to-severe bloating (5.2% with plecanatide 3 mg and 3.4% with plecanatide 6 mg) than in patients with mild bloating at baseline (0% and 4.2%, respectively).
Investigators concluded that plecanatide demonstrated simultaneous and significant improvements in abdominal pain, bloating, and CSBM frequency in women aged 18 to 40 years with IBS-C and bloating, and these differences were observed regardless of baseline bloating intensity.
References
1. Trulance (plecanatide) [package insert]. Bridgewater, NJ: Salix Pharmaceuticals; 2024.
2. Brenner DM, Fogel R, Dorn SD, et al. Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials. Am J Gastroenterol. 2018;113(5):735-745.
3. Brenner DM, Sharma A, Rao SSC, et al. Plecanatide improves abdominal bloating and bowel symptoms of irritable bowel syndrome with constipation. Dig Dis Sci. 2024;69(5):1731-1738.
4. Brenner DM, Neshatian L, Shaya F, Laitman AP, Shahsavari D. Plecanatide is efficacious in women aged 18 to 40 years with IBS-C and bloating: a pooled analysis of two phase 3, randomized, placebo-controlled trials. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P5097.
Efficacy and Safety of Tenapanor in IBS-C: A Systematic Review and Meta-Analysis
Tenapanor is a locally acting inhibitor of sodium/hydrogen exchanger isoform 3 (NHE3) that received FDA approval in 2019 for the treatment of IBS-C.1 By inhibiting sodium and phosphate absorption into the gastrointestinal tract, tenapanor causes fluid retention and softening of stool. Tenapanor also reduces abdominal pain through its effects on visceral hypersensitivity and intestinal permeability.1
Tenapanor was compared with placebo in 3 randomized trials in patients with IBS-C aged 18 to 75 years.2-4 In a phase 2 trial, 365 patients were randomly assigned to tenapanor at 5 mg, 20 mg, or 50 mg, or placebo twice daily for 12 weeks.2 The randomized, phase 3 T3MPO-1 trial compared tenapanor 50 mg twice daily vs placebo for 12 weeks followed by a 4-week crossover period in 629 patients.3 The randomized, phase 3 T3MPO-2 trial compared tenapanor 50 mg vs placebo twice daily for 26 weeks.4 All 3 trials demonstrated a benefit in a composite primary endpoint incorporating abdominal pain and CSBM.2-4
At the ACG 2025 Annual Scientific Meeting, Aref and colleagues reported results of a meta-analysis evaluating the efficacy and safety of tenapanor across these 3 randomized trials that enrolled a total of 1378 patients.5 Tenapanor was associated with significant improvements over placebo in multiple symptoms, including abdominal bloating, cramping, discomfort, fullness, pain, and CSBM (Table 2).
In regard to safety, tenapanor was associated with a significant increase over placebo in the incidence of treatment-related adverse events (TRAEs) (risk ratio [RR], 2.3; 95% CI, 1.72-3.06; P<.01) and AEs leading to treatment discontinuation (RR, 9.08; 95% CI, 3.63-22.71; P<.01). The most common AE with tenapanor was diarrhea, with a frequency significantly higher than placebo (RR, 5.75; 95% CI, 3.44-9.6; P<.01). There was no significant increase in the rate of serious AEs with tenapanor vs placebo. Tenapanor was also associated with a significant reduction in the use of rescue medications compared with placebo (RR, 0.77; 95% CI, 0.68-0.88; P<.01).
The investigators concluded that tenapanor was significantly more effective than placebo across endpoints, particularly in regards to abdominal pain. They noted that, although all 3 trials were multicenter and included patients with similar baseline characteristics, the population was primarily White females. Moreover, the studies used the older Rome III criteria and relied on subjective patient-reported outcomes and diary entries. Additional research is warranted to compare tenapanor with other current therapies for IBS-C.
References
1. Herekar A, Shimoga D, Jehangir A, et al. Tenapanor in the treatment of irritable bowel syndrome with constipation: discovery, efficacy, and role in management. Clin Exp Gastroenterol. 2023;16:79-85.
2. Chey WD, Lembo AJ, Rosenbaum DP. Tenapanor treatment of patients with constipation-predominant irritable bowel syndrome: a phase 2, randomized, placebo-controlled efficacy and safety trial. Am J Gastroenterol. 2017;112(5):763-774.
3. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293.
4. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303.
5. Aref A, Aldermerdash MA, Mohamed I, Abdallfatah A, Abosheaishaa H. Efficacy and safety of tenapanor in IBS-C: a systematic review and meta-analysis. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P2933.
Reduction in Gastrointestinal Visits and Portal Messaging Following Tenapanor Initiation in Patients in Community Gastrointestinal Practices
IBS-C is associated with greater health care resource utilization (HCRU).1 This may increase the use of electronic health record (EHR) systems, including messaging portals, which can increase provider workload when used at high volumes.2 At the ACG 2025 Annual Scientific Meeting, Fossa and colleagues presented results of an observational study analyzing the effects of tenapanor on HCRU in patients with IBS-C based on EHR data.3
The analysis included 712 adults with IBS-C receiving care from one of 350 gastroenterology providers practicing in a larger medical group across 7 states. All patients had at least 1 visit within the past year before starting tenapanor and had initiated tenapanor at least 1 year prior to the EHR data cutoff. Researchers evaluated changes in clinical encounters, defined as the total number of visits and labs, and changes in portal message activity, defined as the total number of messages and patient words, before vs after initiating tenapanor. The portal messaging analysis was limited to patients with at least 1 portal message in the year before starting tenapanor. For both analyses, patients were grouped by tertile as high, moderate, or low users of clinical encounters and portal messaging.
Before starting tenapanor, the number of regular visits per 12 months ranged from 1 to 2 in the low-utilization tertile to 4 to 15 in the high-utilization tertile, and the number of lab visits ranged from 0 in the low-utilization tertile to 4 to 34 in the high-utilization tertile. In the full analysis set, the median change in within-patient gastrointestinal visits after tenapanor initiation was -1 (interquartile range [IQR], -2 to 0) and the median change in labs was 0 (interquartile range, -3 to 1). However, in the high-utilization tertile, the median number of regular visits and labs changed by -3 (IQR, -4 to -2) and -4 (-7 to -3), respectively (Figure 2).
Changes in patient portal messaging after initiating tenapanor were assessed for 140 eligible patients. Before starting tenapanor, the number of messages per 12 months ranged from 1 to 2 in the low-utilization tertile to 10 to 61 in the high-utilization tertile, and the number of message words per 12 months ranged from 4 to 133 and from 606 to 5270, respectively.
In the full analysis set, the median change in the number of portal messages was -1 (IQR, -3 to 3) and the median number of patient message words changed by -38 (IRQ, -257 to 227). In the high-message-utilization quartile, the median number of messages changed by -6 (IQR, -19 to 2) and the median number of patient message words changed by -531 (IQR, 1059 to 54) (Figure 2).
Investigators concluded that their preliminary findings indicate that in patients with IBS-C requiring high HCRU, gastrointestinal-related clinical encounters and patient portal message activity are both reduced after starting tenapanor. However, the investigators cautioned that they did not assess medication compliance, they lacked a comparator group, and the portal messaging cohort was small. However, if tenapanor does yield reductions in HCRU, this could benefit both patients and providers and may reduce costs.
References
1. DiBonaventura M, Sun SX, Bolge SC, Wagner JS, Mody R. Health-related quality of life, work productivity and health care resource use associated with constipation predominant irritable bowel syndrome. Curr Med Res Opin. 2011;27(11):2213-2222.
2. Benson M, Gopal D, Pfau P. Electronic health record work demands for gastroenterology and hepatology providers: a prospective use analysis and survey study. Dig Dis Sci. 2023;68(4):1218-1225.
3. Fossa A, Scott L, Khapra A, Viswanathan L, Staller K. Reduction in gastrointestinal visits and portal messaging following tenapanor initiation in patients in community gastrointestinal practices. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P0787.
Improvement in Health-Related Quality of Life in Adults With IBS-C Not Achieving Bowel Movement Frequency Criterion: Analysis of Two Phase 3 Plecanatide Trials
Plecanatide demonstrated a significant benefit over placebo in 2 randomized, phase 3 trials in patients with IBS-C.1 The trials used a composite efficacy endpoint that included changes in CSBMs during the treatment period. The threshold for stool frequency response included in the trial—an increase of at least 1 CSBM from baseline per week for at least one-half of the treatment—was recommended by the FDA.2 However, even patients not meeting this threshold may derive other benefits from plecanatide. At the ACG 2025 Annual Scientific Meeting, Brenner and colleagues presented results of a post hoc analysis evaluating changes in health-related QOL (HRQOL) in patients with IBS-C enrolled in the 2 randomized phase 3 trials of plecanatide who did not meet the FDA-recommended threshold for a CSBM response.3
The analysis included 928 patients from the trials who were randomly assigned to plecanatide 3 mg (n=428) or placebo (n=500) who did not attain an increase from baseline of at least 1 CSBM per week for at least 6 of 12 treatment weeks during the trials. HRQOL was assessed using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, which was administered at baseline and at weeks 4, 8, 12, and 14. A change of at least 14 points from baseline was considered a minimal clinically important difference in IBS-QOL, as previously validated.4
Overall, the percentage of patients with a clinically meaningful improvement in IBS-QOL total score at week 12 was significantly higher in the plecanatide group than the placebo group (36.9% vs 28.8%; P<.01) (Figure 3). Nonsignificant numerical improvements were observed with plecanatide vs placebo for 7 of the 8 IBS-QOL subdomains, including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, and relationship.
In the safety analysis, plecanatide was well tolerated and the most common AEs were diarrhea, reported in 4.9% of patients receiving plecanatide 3 mg and 1.0% of patients receiving placebo, and headache, reported in 2.3% and 2.2% of patients, respectively. In summary, plecanatide was associated with clinically meaningful improvements in IBS-QOL even in patients not meeting the stringent FDA definition for CSBM response. Investigators commented that patients with IBS may experience QOL improvements independent from changes in bowel habits.
References
1. Brenner DM, Fogel R, Dorn SD, et al. Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials. Am J Gastroenterol. 2018;113(5):735-745.
2. U.S. Food and Drug Administration. Guidance for Industry: irritable bowel syndrome – clinical evaluation of drugs for treatment. May 2012. Available at https://www.fda.gov/media/78622/download. Accessed November 5, 2025.
3. Brenner DM, George B, Laitman AP, Luo Y. Improvement in health-related quality of life in adults with IBS-C not achieving bowel movement frequency criterion: analysis of two phase 3 plecanatide trials. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P5098.
4. Drossman D, Morris CB, Hu Y, et al. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol. 2007;102(7):1442-1453.
Treatment Satisfaction With Tenapanor: Real-World Survey of Patients With IBS-C
Scott and colleagues presented results of a real-world survey assessing treatment satisfaction, changes in IBS-C symptoms, and changes in QOL in patients receiving tenapanor for IBS-C.1 The analysis included 537 patients who had initiated tenapanor at least 6.5 weeks prior to the survey start and had a prescription dispensed within the past 90 days. The survey included both objective and open-ended questions. For the open-ended questions, responses were analyzed by researchers and categorized manually on a scale from -2 (negative sentiment) to +2 (positive sentiment), with scores of 1 or 2 considered a positive sentiment. They also manually identified and quantified themes that arose across patient entries. Patient characteristics were not collected as part of the survey.
Approximately 88% of respondents said that they were either somewhat satisfied (23.1%) or extremely satisfied (64.4%) with their treatment experience with tenapanor. Approximately 11% were somewhat dissatisfied (4.7%) or extremely dissatisfied (6.0%). Most patients reported at least some improvement in constipation (95.1%), bloating (75.1%), and abdominal pain (83.9%) (Figure 4), and 69.1% of patients had improvement of all 3 symptoms.
The majority of respondents reported QOL improvements with tenapanor, indicating that the medication had significantly improved their ability to participate in work (74%) and social activities and exercise (74%). In a multivariate analysis, factors associated with QOL improvement with tenapanor included improvements in constipation (odds ratio [OR], 2.80; 95% CI, 1.10-7.18; P=.03), bloating (OR, 3.05; 95% CI, 1.94-4.79; P<.001), and abdominal pain (OR, 4.02; 95% CI, 2.33-6.92; P<.001). Improvement in constipation was significantly associated with treatment satisfaction (OR, 3.19; 95% CI, 1.23-8.23; P=.02).
In the open-ended questions, 93% of patients (n=298) expressed positive sentiments about their experience with tenapanor; 87% provided positive statements, including improvements in QOL and symptoms, superiority over other medications, and/or gratitude for the medication. A total of 30% expressed challenges, including side effects and incomplete symptom resolution. Fewer than 3% stated that potential side effects had negatively affected their QOL.
Comparing tenapanor with their experience with other IBS-C medications (n=328), 89% expressed positive sentiments about tenapanor and 76% said that tenapanor was better than other medications they had used, primarily because it worked better and/or had fewer side effects.
The investigators noted that the survey was limited to patients who had received tenapanor for at least 6.5 weeks and thus the findings do not reflect the experiences of patients who discontinue tenapanor earlier. The investigators added that there was a lack of placebo control. Moreover, patients were receiving free product at the time of the survey, which could introduce bias. With those caveats, the researchers concluded that the survey highlights the effectiveness of tenapanor in patients with IBS-C, with most patients reporting treatment satisfaction, improvements in symptoms and QOL, and superiority of tenapanor over other IBS-C medications.
Reference
1. Scott L, Ruddy J, Sibelli A, Gist B, Williams L, Gray TD, Chakraborty S. Treatment satisfaction with tenapanor: real-world survey of patients with IBS-C. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P5062.
Real-World Safety Analysis of the Constipation-Predominant IBS Treatment Options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor
At the ACG 2025 Annual Scientific Meeting, Andrews and Adler presented results of a real-world analysis of the safety of the 4 medications FDA-approved for IBS-C: linaclotide, lubiprostone, plecanatide, and tenapanor.1 The researchers obtained safety data from the FDA Adverse Event Reporting System (FAERS) database, an open, public-access database that allows submissions from any individual, including anonymous patients and providers. The database was queried for each drug from its date of FDA approval through the last available update on June 30, 2024. Reports with other suspected drugs and reports with reasons for use of the medication other than IBS and/or constipation were excluded from the analysis.
Among the 5787 reports for linaclotide, 65.4% of patients were female (median age, 66 years) and 30.8% were male (median age, 73 years). Most events (86.6%) were nonserious; 3.0% of patients were hospitalized, 0.8% were disabled, 0.2% had life-threatening events, and 0.8% died.
Among the 670 reports for lubiprostone, 73.6% of patients were female (median age, 51 years) and 18.4% were male (median age, 72 years). Approximately one-half of events (48.5%) were nonserious; 18.7% of patients were hospitalized, 2.2% had life-threatening events, 1.9% were disabled, and 1.9% died. Another 32.1% of events had outcomes classified as “other.”
Among the 368 reports for plecanatide, 60.3% of patients were female (median age, 66 years) and 19.3% were male (median age, 69 years). Most events (85.1%) were nonserious; 3.3% of patients were hospitalized, 1.6% died, and 0.5% had life-threatening events.
Among the 122 reports for tenapanor, 70.5% of patients were female (median age, 70 years) and 16.4% were male (median age, 60.5 years). Most events (76.2%) were nonserious; 12.3% of patients were hospitalized, and 3.3% died. Another 11.5% reported outcomes classified as “other.”
Across the 4 medications, the most frequent AEs reported were gastrointestinal, most frequently diarrhea, followed by abdominal pain, bloating, and nausea/vomiting. Several distinct, serious AEs were reported that Dr Andrews noted warrant further investigation, including clinically significant dehydration with linaclotide, and dyspnea and chest pain with lubiprostone.
Dr Andrews cautioned that the FAERS database cannot be used to determine causation or AE incidence rates and that results should be interpreted with caution. He added that prospective trials are needed to further evaluate AEs associated with these agents.
Reference
1. Andrews MB, Adler DG. Real-world safety analysis of the constipation-predominant irritable bowel syndrome treatment options linaclotide, lubiprostone, plecanatide, and tenapanor. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P5083.
Exploring the Efficacy and Safety of Linaclotide in Pediatric Patients of Functional Constipation and IBS-C: A Meta-Analysis of Randomized Control Trials
The guanylate cyclase-C agonist linaclotide was the first drug to receive FDA approval for the treatment of children aged 6 to 17 years with functional constipation.1 However, the optimal role of linaclotide in pediatric populations has not been well defined. At the ACG 2025 Annual Scientific Meeting, Khan and colleagues presented results of a meta-analysis evaluating clinical responses, dose-response patterns, and AEs associated with linaclotide in children with functional constipation and IBS-C.2
The analysis included 3 randomized clinical trials of linaclotide in 309 pediatric patients with functional constipation and IBS-C. Across these trials, linaclotide was associated with significant improvements over placebo in stool consistency and straining severity but not in CSBMs, abdominal pain, or bloating. The benefits observed with linaclotide were particularly evident at higher doses. Rates of TEAEs and TRAEs were not significantly different between groups.
With these findings, investigators concluded that linaclotide may have a benefit in improving stool consistency but has minimal effects on other symptoms.
References
1. U.S. Food & Drug Administration. FDA approves first treatment for pediatric functional constipation. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-pediatric-functional-constipation. Accessed November 3, 2025.
2. Khan MS, Khalid M, Siddiqui E, et al. Exploring the efficacy and safety of linaclotide in pediatric patients of functional constipation and IBS-C: a meta-analysis of randomized control trials. Presented at: American College of Gastroenterology 2025 Annual Scientific Meeting; October 24-29, 2025; Phoenix, Arizona, USA. Abstract P1891.