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IRONWOOD PHARMACEUTICALS INC (IRWD)

Ironwood Pharmaceuticals, Inc. operates as a healthcare enterprise primarily dedicated to discovering, developing, and commercializing therapeutic solutions for gastrointestinal (GI) conditions. Its flagship commercial product is linaclotide, a guanylate cyclase type-C (GC-C) agonist. This medication is prescribed for adult patients managing irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), sold as LINZESS in the United States and Mexico, and under the CONSTELLA brand throughout Canada and the European Union. Beyond its marketed offerings, Ironwood's development pipeline includes IW-3300, another GC-C agonist targeting various visceral pain conditions, such as interstitial cystitis/bladder pain syndrome and endometriosis. Additionally, the company is advancing CNP-104, an immune nanoparticle being investigated for biliary cholangitis. Ironwood maintains key strategic alliances with AbbVie Inc., AstraZeneca AB, and Astellas Pharma Inc. to support the ongoing development and market introduction of linaclotide. Established in 1998, the Boston, Massachusetts-based firm initially operated as Microbia, Inc. before officially rebranding to Ironwood Pharmaceuticals, Inc. in April 2008.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Ironwood Pharmaceuticals, Inc. logo

Ironwood Pharmaceuticals, Inc.

NASDAQ:IRWDHealthcare
-3.31%$3.50
AH$3.51+0.29%vs close
Mkt Cap$578.34M
Float150.04M
O/S165.24M
Vol
$ Vol
RVOL
Inst Own97.0%
SI10.6%
Earnings
Dilution
Phase Distribution
25 lead-sponsored trials·0 active·20 completed
Phase 13
Phase 213
Phase 37
Phase 42
(17 more as collaborator)
Status Overview
Completed20
Stopped5

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Terminated

    A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

    Linaclotide, Placebo

    Irritable Bowel Syndrome Characterized by Constipation

    Enrollment
    20
    Start
    Dec 2016
    Primary Completion
    Oct 2018
    Completion
    Oct 2018
    NCT02837783
  • Phase 4
    Terminated

    A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

    Lesinurad, XOI

    Gout, Chronic Kidney Disease (CKD)

    Enrollment
    242
    Start
    Jul 2017
    Primary Completion
    Feb 2019
    Completion
    Feb 2019
    NCT03226899
  • Phase 3
    Completed

    Trial of Linaclotide in Patients With Chronic Constipation

    Matching Placebo, Linaclotide

    Chronic Constipation

    Enrollment
    643
    Start
    Aug 2008
    Primary Completion
    Aug 2009
    Completion
    Oct 2009
    NCT00730015
  • Phase 3
    Completed

    An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

    Linaclotide

    Irritable Bowel Syndrome With Constipation, Chronic Constipation

    Enrollment
    1,743
    Start
    Sep 2008
    Primary Completion
    Mar 2012
    Completion
    Mar 2012
    NCT00730171
  • Phase 3
    Completed

    Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    Linaclotide or Matching Placebo

    Irritable Bowel Syndrome With Constipation

    Enrollment
    805
    Start
    Jul 2009
    Primary Completion
    Sep 2010
    Completion
    Sep 2010
    NCT00938717
  • Phase 3
    Completed

    Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

    Linaclotide, Matching Placebo

    Chronic Idiopathic Constipation

    Enrollment
    1,223
    Start
    Oct 2014
    Primary Completion
    Aug 2015
    Completion
    Aug 2015
    NCT02291679
  • Phase 3
    Terminated

    A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

    IW-3718, placebo

    Gastroesophageal Reflux Disease (GERD)

    Enrollment
    495
    Start
    Jun 2018
    Primary Completion
    Oct 2020
    Completion
    Nov 2020
    NCT03561090
  • Phase 3
    Completed

    Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

    IW-3718, placebo

    Gastroesophageal Reflux Disease (GERD)

    Enrollment
    609
    Start
    Sep 2018
    Primary Completion
    Jul 2020
    Completion
    Nov 2020
    NCT03561883
  • Phase 3
    Completed

    A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    Linaclotide, Placebo

    Irritable Bowel Syndrome Characterized by Constipation

    Enrollment
    614
    Start
    Jun 2018
    Primary Completion
    Mar 2019
    Completion
    Apr 2019
    NCT03573908
  • Phase 2
    Completed

    Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS

    MD-1100 Acetate

    Irritable Bowel Syndrome

    Enrollment
    36
    Start
    Jan 2006
    Primary Completion
    -
    Completion
    Sep 2006
    NCT00258193
  • Phase 2
    Completed

    Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

    MD-1100 Acetate

    Constipation

    Enrollment
    40
    Start
    Mar 2006
    Primary Completion
    -
    Completion
    Aug 2006
    NCT00306748
  • Phase 2
    Completed

    Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

    linaclotide acetate, Matching placebo

    Chronic Constipation

    Enrollment
    310
    Start
    Nov 2006
    Primary Completion
    Dec 2007
    Completion
    Feb 2008
    NCT00402337
  • Phase 2
    Completed

    Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia

    MD-0727

    Hypercholesterolemia

    Enrollment
    150
    Start
    Nov 2006
    Primary Completion
    -
    Completion
    Jul 2007
    NCT00404001
  • Phase 2
    Completed

    Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    Linaclotide Acetate, Matching placebo

    Irritable Bowel Syndrome With Constipation

    Enrollment
    420
    Start
    Apr 2007
    Primary Completion
    Feb 2008
    Completion
    Apr 2008
    NCT00460811
  • Phase 2
    Completed

    Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

    IW-6118, Matching Placebo

    Healthy

    Enrollment
    90
    Start
    Jun 2010
    Primary Completion
    Aug 2010
    Completion
    Aug 2010
    NCT01107236
  • Phase 2
    Terminated

    Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

    IW-9179, Placebo

    Dyspepsia, Functional Gastrointestinal Disorders

    Enrollment
    10
    Start
    Oct 2012
    Primary Completion
    Feb 2014
    Completion
    Mar 2014
    NCT01712412
  • Phase 2
    Completed

    Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors

    IW-3718, Matching Placebo

    Gastroesophageal Reflux

    Enrollment
    93
    Start
    Feb 2014
    Primary Completion
    Dec 2014
    Completion
    Dec 2014
    NCT02030925
  • Phase 2
    Completed

    Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)

    IW-9179, Matching Placebo

    Diabetic Gastroparesis

    Enrollment
    90
    Start
    Oct 2014
    Primary Completion
    Dec 2015
    Completion
    Dec 2015
    NCT02289846
  • Phase 2
    Completed

    Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    Linaclotide, Matching Placebo

    Irritable Bowel Syndrome With Constipation

    Enrollment
    759
    Start
    Oct 2015
    Primary Completion
    Sep 2016
    Completion
    Sep 2016
    NCT02559206
  • Phase 2
    Completed

    A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

    IW-3718, Matching Placebo

    Gastroesophageal Reflux Disease

    Enrollment
    282
    Start
    Mar 2016
    Primary Completion
    Apr 2017
    Completion
    Apr 2017
    NCT02637557
  • Phase 2
    Completed

    A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

    MD-7246, Placebo

    Irritable Bowel Syndrome With Diarrhea (IBS-D)

    Enrollment
    515
    Start
    May 2019
    Primary Completion
    Feb 2020
    Completion
    Mar 2020
    NCT03931785
  • Phase 2
    Terminated

    A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

    IW-3300 rectal foam, Placebo

    Interstitial Cystitis, Bladder Pain Syndrome

    Enrollment
    98
    Start
    Mar 2023
    Primary Completion
    Jan 2025
    Completion
    Feb 2025
    NCT05740007
  • Phase 1
    Completed

    Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

    Microgestin®, Levothyroxine

    Healthy Volunteers

    Enrollment
    87
    Start
    Mar 2019
    Primary Completion
    Jun 2019
    Completion
    Jul 2019
    NCT03856970
  • Phase 1
    Completed

    A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers

    IW-3300, Placebo

    Healthy Volunteers

    Enrollment
    32
    Start
    Jan 2022
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT05188261
  • Phase 1
    Completed

    A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects

    IW-3300, Placebo

    Healthy Volunteers

    Enrollment
    18
    Start
    May 2022
    Primary Completion
    Jun 2022
    Completion
    Jul 2022
    NCT05362695