Julie Khlevner, MD, discusses the impact of FDA-approved LINZESS for functional constipation

On May 21, 2026, the FDA expanded approval of linaclotide (LINZESS) to include pediatric patients aged 2 to 5 years with functional constipation (FC), making it the only FDA-approved prescription therapy for pediatric FC across this age range. The decision was supported by phase 3 clinical trial data demonstrating improvements in spontaneous bowel movement frequency compared with placebo.¹

In an interview discussing the approval, Julie Khlevner, MD, pediatric gastroenterologist and associate professor at Columbia University Vagelos College of Physicians and Surgeons, emphasized the significance of the expanded indication for a condition commonly managed in primary care and pediatric gastroenterology settings.

“Functional constipation is one of the most common conditions treated by pediatricians and pediatric gastroenterologists,” Khlevner said. She noted that younger children often have limited evidence-based treatment options, particularly when dietary changes, behavioral interventions, and over-the-counter therapies fail to adequately control symptoms.

According to Khlevner, the expanded approval helps fill a longstanding treatment gap for preschool-aged children who may experience chronic symptoms affecting multiple aspects of daily life.

“The FDA expanded approval of linaclotide for children as young as 2 really provides clinicians with the first FDA-approved prescription therapy specifically indicated for functional constipation across a broader age group,” she said. “It helps address an important treatment gap, particularly for preschool children who can experience chronic symptoms that affect quality of life, toileting, feeding, school readiness, and overall family well-being.”

Quality-of-life outcomes remain a key treatment goal

Khlevner highlighted that treatment success extends beyond increasing bowel movement frequency. She said clinicians should focus on outcomes that meaningfully affect children and families.

Among the most important goals are resolution of painful defecation, reduction in stool-withholding behaviors, improvement in stool consistency, and fewer episodes of fecal incontinence or soiling. She noted that these symptoms can affect school attendance, social functioning, and caregiver burden.

“One of the most important ones that usually is overlooked is the quality of life improvement for both children and their families,” Khlevner said.

She also emphasized the importance of sustained symptom control rather than short-term improvements, noting that functional constipation frequently requires long-term management.

New option complements existing treatment approaches

Khlevner pointed to recently published joint guidelines from the European and North American pediatric gastroenterology societies that recommend education, lifestyle modifications, behavioral interventions, dietary counseling, and over-the-counter laxatives as foundational therapies.

However, she acknowledged that some children do not respond adequately to these measures or are unable to tolerate available treatments because of side effects or refusal to take medication.

The availability of linaclotide may provide an alternative in those situations. Khlevner noted that the capsule can be opened and mixed with applesauce or water, offering flexibility for younger children who may struggle with traditional medication formulations.

“In pediatric practice, ease of administration is a key determinant of adherence,” she said. “Even an effective therapy may have limited real-world benefit if families struggle to give it consistently.”

She added that alternative administration methods may help reduce treatment burden for caregivers, improve acceptance, and support reliable daily dosing, which is particularly important because therapeutic success often depends on treatment maintained over months.

Trial data support expanded indication

The FDA approval was based on findings from a 12-week phase 3 randomized, placebo-controlled trial in children aged 2 to 5 years with FC. Linaclotide 72 mcg improved spontaneous bowel movement frequency compared with placebo, and the safety findings were generally consistent with those observed in adult and older pediatric studies.

In the accompanying announcement, Khlevner said, “Managing functional constipation in young children is especially challenging, as this vulnerable patient population often continues to experience persistent symptoms despite treatment with over-the-counter therapies.”

She added, “The availability of an FDA-approved therapy with an established safety profile expands evidence-based treatment options and may support a more tailored therapeutic approach for children aged 2-5 years.”

Looking ahead, Khlevner said the greatest benefit will likely come from incorporating linaclotide into a comprehensive management strategy that includes education, behavioral interventions, toileting routines, and ongoing follow-up to support long-term treatment success.

Reference

1. Ironwood Pharmaceuticals. FDA Approves Use of LINZESS® (linaclotide) in Pediatric Patients Two Years of Age and Older with Functional Constipation (FC). BioSpace. May 27, 2026. Accessed June 3, 2026. https://www.biospace.com/press-releases/fda-approves-use-of-linzess-linaclotide-in-pediatric-patients-two-years-of-age-and-older-with-functional-constipation-fc