Linzess FDA Approval History
FDA Approved: Yes (First approved August 30, 2012)
Brand name: Linzess
Generic name: linaclotide
Dosage form: Capsules
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Irritable Bowel Syndrome with Constipation, Chronic Idiopathic Constipation, Functional Constipation
Linzess (linaclotide) is a guanylate cyclase-C agonist used for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients 6 to 17 years of age.
- Linzess is an agonist of the guanylate cyclase type-C receptor located on the luminal surface of the intestine. It works to treat constipation by increasing fluid secretion, and accelerating intestinal transit.
- Linzess is administered orally once daily at least 30 minutes prior to a meal.
- The product label for Linzess carries a Boxed Warning for the risk of serious dehydration in pediatric patients less than two years of age. Warnings and precautions associated with Linzess include severe diarrhea.
- Common adverse reactions in adult patients with IBS-C or CIC include diarrhea, abdominal pain, flatulence and abdominal distension.
Common adverse reactions in pediatric patients 6 to 17 years of age with FC include diarrhea.
Development timeline for Linzess
Further information
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