AbbVie’s Linaclotide Study: A Potential Breakthrough for Pediatric Constipation

Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.

Study Overview: AbbVie, in collaboration with Ironwood Pharmaceuticals, has completed a Phase 2 study titled ‘A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC).’ The study aimed to assess adverse events and changes in disease activity in pediatric participants treated with linaclotide, addressing a significant gap as no pharmacological therapies are currently approved for FC in this age group.

Intervention/Treatment: The study tested linaclotide, an oral drug, to treat functional constipation in young children. Participants received different doses of linaclotide or a placebo to evaluate its safety and efficacy.

Study Design: This interventional study was randomized and sequential, with a quadruple masking approach involving participants, care providers, investigators, and outcomes assessors. The primary purpose was treatment-focused, with participants receiving daily doses of linaclotide or placebo for four weeks.

Study Timeline: The study began on April 27, 2023, and was completed with the last update submitted on June 23, 2025. These dates are crucial as they mark the progression and conclusion of the study, providing a timeline for potential market entry.

Market Implications: The completion of this study may positively influence AbbVie’s stock performance by potentially leading to the first approved treatment for pediatric functional constipation, a significant unmet medical need. This development could enhance investor sentiment and position AbbVie favorably against competitors in the pediatric pharmaceutical market.

The study is completed, and further details are available on the ClinicalTrials portal.