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Linaclotide - Ironwood Pharmaceuticals

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Drug Profile

Linaclotide - Ironwood Pharmaceuticals

Alternative Names: ASP-0456; ASP-456; Constella; Linaclotide acetate; Linzess; MD-1100; MD-7246; MM-416775

Latest Information Update: 29 May 2026

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At a glance

  • Originator Microbia
  • Developer AbbVie; Astellas Pharma; AstraZeneca; Ironwood Pharmaceuticals
  • Class Gastrokinetics; Irritable bowel syndrome therapies; Laxatives; Non-opioid analgesics; Oligopeptides
  • Mechanism of Action Enterotoxin receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Constipation; Irritable bowel syndrome
  • Discontinued Visceral pain

Most Recent Events

  • 27 May 2026 US FDA approves linaclotide for Constipation (In adolescents, In children) in USA (PO)
  • 07 May 2026 FDA assigns PDUFA action date of 24/05/2026 for linaclotide for functional Constipation (In children)
  • 02 May 2026 Adverse events data from a phase II trial in Constipation presented at the Digestive Disease Week 2026 (DDW-2026)

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