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IRWD's Linzess Wins FDA Nod for Expanded Pediatric Constipation Use
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Key Takeaways
IRWD won FDA approval to expand the use of Linzess in pediatric FC patients aged two years and older.
IRWD's expanded pediatric label is backed by phase III data showing higher bowel movement frequency.
AbbVie, Astellas and AstraZeneca support Linzess commercialization across key global markets.
Ironwood Pharmaceuticals (IRWD - Free Report) announced that the FDA has approved the expanded use of its sole marketed drug, Linzess (linaclotide), for the treatment of functional constipation (FC) in pediatric patients aged two years and older. The therapy was approved for FC in children and adolescents aged six to 17 years in 2023. Linzess is the only FDA-approved daily treatment for pediatric FC.
Although the FDA decision was expected on May 24, 2026, the approval came after a brief three-day delay.
Linzess is already approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients aged seven years and older. The drug is also approved for chronic idiopathic constipation (CIC) in adults.
Year to date, shares of Ironwood have risen 10.1% against the industry’s 6.5% fall.
Image Source: Zacks Investment Research
The FDA approval for the label expansion of Linzess in children aged two to five years with FC was based on data from a phase III study which demonstrated that treatment with Linzess led to a significant increase in spontaneous bowel movement frequency compared with placebo. The safety profile remained consistent with previous studies in adults with CIC and older pediatric FC patients.
FC in children is a chronic condition marked by hard, infrequent and often painful bowel movements.
Global Partnerships Expand IRWD’s Linzess Commercial Reach
Ironwood has a partnership with AbbVie (ABBV - Free Report) to jointly develop and commercialize Linzess in the United States for IBS-C, CIC and FC. AbbVie markets the drug as Constella in Europe and Canada for the treatment of adults with moderate to severe IBS-C.
The global partnerships with Astellas Pharma and AstraZeneca (AZN - Free Report) support Linzess’ development and commercialization in Japan and China, respectively. Both companies are liable to pay royalties to Ironwood on net Linzess revenues generated in the regions.
Linzess delivered strong growth in the first quarter of 2026, with U.S. net sales reported by AbbVie rising 97% year over year to $272.5 million. Ironwood recorded $104.2 million as its share of net profit from U.S. sales, up 169% from the prior year, while total prescription demand grew 5%. AbbVie expects full-year 2026 U.S. sales of Linzess to reach between $1.13 billion and $1.18 billion, supporting Ironwood’s outlook for continued strong profit growth from the drug.
IRWD’s Zacks Rank
Ironwood currently carries a Zacks Rank #4 (Sell).
View the Zacks #1 Rank List
Image: Bigstock
IRWD's Linzess Wins FDA Nod for Expanded Pediatric Constipation Use
Key Takeaways
Ironwood Pharmaceuticals (IRWD - Free Report) announced that the FDA has approved the expanded use of its sole marketed drug, Linzess (linaclotide), for the treatment of functional constipation (FC) in pediatric patients aged two years and older. The therapy was approved for FC in children and adolescents aged six to 17 years in 2023. Linzess is the only FDA-approved daily treatment for pediatric FC.
Although the FDA decision was expected on May 24, 2026, the approval came after a brief three-day delay.
Linzess is already approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients aged seven years and older. The drug is also approved for chronic idiopathic constipation (CIC) in adults.
Year to date, shares of Ironwood have risen 10.1% against the industry’s 6.5% fall.
Image Source: Zacks Investment Research
The FDA approval for the label expansion of Linzess in children aged two to five years with FC was based on data from a phase III study which demonstrated that treatment with Linzess led to a significant increase in spontaneous bowel movement frequency compared with placebo. The safety profile remained consistent with previous studies in adults with CIC and older pediatric FC patients.
FC in children is a chronic condition marked by hard, infrequent and often painful bowel movements.
Global Partnerships Expand IRWD’s Linzess Commercial Reach
Ironwood has a partnership with AbbVie (ABBV - Free Report) to jointly develop and commercialize Linzess in the United States for IBS-C, CIC and FC. AbbVie markets the drug as Constella in Europe and Canada for the treatment of adults with moderate to severe IBS-C.
The global partnerships with Astellas Pharma and AstraZeneca (AZN - Free Report) support Linzess’ development and commercialization in Japan and China, respectively. Both companies are liable to pay royalties to Ironwood on net Linzess revenues generated in the regions.
Linzess delivered strong growth in the first quarter of 2026, with U.S. net sales reported by AbbVie rising 97% year over year to $272.5 million. Ironwood recorded $104.2 million as its share of net profit from U.S. sales, up 169% from the prior year, while total prescription demand grew 5%. AbbVie expects full-year 2026 U.S. sales of Linzess to reach between $1.13 billion and $1.18 billion, supporting Ironwood’s outlook for continued strong profit growth from the drug.
IRWD’s Zacks Rank
Ironwood currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.