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Ironwood Pharmaceuticals (IRWD) FDA Events

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FDA Events for Ironwood Pharmaceuticals (IRWD)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ironwood Pharmaceuticals (IRWD). Over the past two years, Ironwood Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as apraglutide, linaclotide, and SBS-IF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ironwood Pharmaceuticals' Drugs in FDA Review

apraglutide - FDA Regulatory Timeline and Events

apraglutide is a drug developed by Ironwood Pharmaceuticals for the following indication: For patients with short bowel syndrome (SBS) with intestinal failure (IF). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

linaclotide - FDA Regulatory Timeline and Events

linaclotide is a drug developed by Ironwood Pharmaceuticals for the following indication: For the treatment of functional constipation in this pediatric population. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SBS-IF - FDA Regulatory Timeline and Events

SBS-IF is a drug developed by Ironwood Pharmaceuticals for the following indication: Digestive Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Ironwood Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Ironwood Pharmaceuticals (IRWD) has reported FDA regulatory activity for the following drugs: linaclotide, SBS-IF and apraglutide.

The most recent FDA-related event for Ironwood Pharmaceuticals occurred on April 14, 2025, involving apraglutide. The update was categorized as "Provided Update," with the company reporting: "Ironwood Pharmaceuticals, Inc announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support."

Current therapies from Ironwood Pharmaceuticals in review with the FDA target conditions such as:

  • For the treatment of functional constipation in this pediatric population. - linaclotide
  • Digestive Disease - SBS-IF
  • For patients with short bowel syndrome (SBS) with intestinal failure (IF) - apraglutide

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:IRWD) was last updated on 7/11/2025 by MarketBeat.com Staff
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