FDA Approves First Drug for Pediatrics With Irritable Bowel Syndrome With Constipation

The FDA has approved linaclotide (Linzess; Ironwood Pharmaceuticals, AbbVie) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). This is the first treatment approved for IBS-C in this population, as announced in a news release from the FDA’s Center for Drug Evaluation and Research.¹

Is Linaclotide Effective?

The FDA cited efficacy and safety data from clinical trials as backing up linaclotide’s approval. Linaclotide’s effectiveness was established in pediatrics 7 years and older by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week, double-blind, randomized, parallel-group phase 3 trial (NCT04026113).^2,3

The trial was conducted across 64 clinic or hospital sites in 7 countries. Patients aged 6 through 17 years who met modified Rome III criteria for functional constipation were randomly assigned to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks. The primary efficacy end point was change from baseline in the 12-week frequency rate of spontaneous bowel movements (SBMs) per week.³

Patients treated with linaclotide demonstrated significant improvement in SBM frequency (2.22 SBMs per week [95% CI, 0.65-1.69]; P < .001) compared with placebo. Linaclotide meaningfully improved stool consistency over placebo (1.11 vs 0.69 [95% CI, 0.21-0.64]; P = .0001).³

Is Linaclotide Safe?

The FDA reports that linaclotide’s safety across these clinical studies is comparable to safety in adults. In the phase 3 trial, the most frequent treatment-emergent adverse event (TEAE) experienced by patients treated with linaclotide was diarrhea. There was one serious adverse event of special interest, which was treatment-related severe diarrhea that occurred in a 17-year-old female receiving linaclotide. The patient experienced severe dehydration and hospitalization; the case resolved following the administration of intravenous fluids.³

In its news release, the FDA cautions health care professionals to monitor patients for severe diarrhea, and that if it occurs, linaclotide should be discontinued and the patient should be rehydrated. Importantly, the FDA notes that patients younger than 2 years can be at risk of serious dehydration and should not take linaclotide for any indication. This also applies to patients with a known or suspected mechanical gastrointestinal obstruction.¹

Past Approvals and Pharmacist Considerations

Linaclotide has previously been approved by the FDA for the treatment of functional constipation in pediatric patients aged 6 through 17 years. This approval was based on the previous clinical trial data, which demonstrated improvements compared with placebo in SBM frequency rate. Linaclotide has been available since 2012 for the treatment of adults with IBS-C or chronic idiopathic constipation. The treatment is now available for pediatrics, who can face vast clinical and real-world complications when dealing with IBS-C.⁴

IBS-C commonly affects children and adolescents. It is characterized by chronic constipation, abdominal pain, and bloating. Although there are many types of IBS—and they all can cause bowel movement alterations and abdominal pain—the symptoms are more distinct if a patient is diagnosed with IBS-C. A feeling of a rock or blockage in the stomach, hard or lumpy stool, and feeling as though the bowel cannot pass stools completely are indications that a case of IBS may be something more.^1,5

Linaclotide differs from laxatives and is part of a class of drugs called guanylate cyclase-C (GC-C) agonists. Linaclotide activates the GC-C receptor in the intestine, which results in increased intestinal fluid secretion and accelerated transit, while decreasing the activity of pain-sensing nerves in the intestine. Pharmacists may find an option like linaclotide more palatable for patients—especially younger ones—compared with laxatives.⁴

Pharmacists can be assured of linaclotide’s clinical efficacy and safety and should educate themselves and prepare for counseling sessions with both the patient and their parent or guardian regarding the possible use of linaclotide. Patients with IBS-C should be informed about the availability of linaclotide and be given the opportunity to ask questions or express concerns with treatment. Linaclotide is poised to reduce the scourge of IBS-C on countless children, improving their quality of life in pivotal developmental years.

REFERENCES

1. FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation. FDA. November 5, 2025. Accessed November 5, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-1st-drug-children-7-years-and-older-irritable-bowel-syndrome-constipation

2. Linaclotide safety and efficacy in pediatric participants, 6 to 17 years of age, with irritable bowel syndrome with constipation (IBS-C) or functional constipation (FC). ClinicalTrials.gov. Updated November 26, 2024. Accessed November 5, 2025. https://clinicaltrials.gov/study/NCT04026113

3. Di Lorenzo C, Khlevner J, Rodriguez-Araujo G, et al. Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2024;9(3):238-250. doi:10.1016/S2468-1253(23)00398-9

4. Ironwood Pharmaceuticals announces FDA approval of new indication for Linzess (linaclotide) for the treatment of functional constipation in pediatric patients aged 7-17 years old. News release. Ironwood Pharmaceuticals. June 12, 2023. Accessed November 5, 2025. https://investor.ironwoodpharma.com/press-releases/press-release-details/2023/Ironwood-Pharmaceuticals-Announces-FDA-Approval-of-New-Indication-for-LINZESS-linaclotide-for-the-Treatment-of-Functional-Constipation-in-Pediatric-Patients-Ages-6-17-Years-Old/default.aspx

5. Cherney K. IBS-C: understanding and treating irritable bowel syndrome with constipation. Healthline. Updated April 11, 2023. Accessed November 5, 2025. https://www.healthline.com/health/ibs-constipation#symptoms