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.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Terminated
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
NCT02837783Enrollment20StartDec 2016Primary CompletionOct 2018CompletionOct 2018 - Phase 4Terminated
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)
NCT03226899Enrollment242StartJul 2017Primary CompletionFeb 2019CompletionFeb 2019 - Phase 3Completed
Trial of Linaclotide in Patients With Chronic Constipation
Matching Placebo, Linaclotide
Chronic Constipation
NCT00730015Enrollment643StartAug 2008Primary CompletionAug 2009CompletionOct 2009 - Phase 3Completed
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
NCT00730171Enrollment1,743StartSep 2008Primary CompletionMar 2012CompletionMar 2012 - Phase 3Completed
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Linaclotide or Matching Placebo
Irritable Bowel Syndrome With Constipation
NCT00938717Enrollment805StartJul 2009Primary CompletionSep 2010CompletionSep 2010 - Phase 3Completed
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Linaclotide, Matching Placebo
Chronic Idiopathic Constipation
NCT02291679Enrollment1,223StartOct 2014Primary CompletionAug 2015CompletionAug 2015 - Phase 3Terminated
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)
NCT03561090Enrollment495StartJun 2018Primary CompletionOct 2020CompletionNov 2020 - Phase 3Completed
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)
NCT03561883Enrollment609StartSep 2018Primary CompletionJul 2020CompletionNov 2020 - Phase 3Completed
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Linaclotide, Placebo
Irritable Bowel Syndrome Characterized by Constipation
NCT03573908Enrollment614StartJun 2018Primary CompletionMar 2019CompletionApr 2019 - Phase 2Completed
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
MD-1100 Acetate
Irritable Bowel Syndrome
NCT00258193Enrollment36StartJan 2006Primary Completion-CompletionSep 2006 - Phase 2Completed
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
MD-1100 Acetate
Constipation
NCT00306748Enrollment40StartMar 2006Primary Completion-CompletionAug 2006 - Phase 2Completed
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
linaclotide acetate, Matching placebo
Chronic Constipation
NCT00402337Enrollment310StartNov 2006Primary CompletionDec 2007CompletionFeb 2008 - Phase 2Completed
Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
MD-0727
Hypercholesterolemia
NCT00404001Enrollment150StartNov 2006Primary Completion-CompletionJul 2007 - Phase 2Completed
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
NCT00460811Enrollment420StartApr 2007Primary CompletionFeb 2008CompletionApr 2008 - Phase 2Completed
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
IW-6118, Matching Placebo
Healthy
NCT01107236Enrollment90StartJun 2010Primary CompletionAug 2010CompletionAug 2010 - Phase 2Terminated
Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
IW-9179, Placebo
Dyspepsia, Functional Gastrointestinal Disorders
NCT01712412Enrollment10StartOct 2012Primary CompletionFeb 2014CompletionMar 2014 - Phase 2Completed
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
IW-3718, Matching Placebo
Gastroesophageal Reflux
NCT02030925Enrollment93StartFeb 2014Primary CompletionDec 2014CompletionDec 2014 - Phase 2Completed
Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
IW-9179, Matching Placebo
Diabetic Gastroparesis
NCT02289846Enrollment90StartOct 2014Primary CompletionDec 2015CompletionDec 2015 - Phase 2Completed
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Linaclotide, Matching Placebo
Irritable Bowel Syndrome With Constipation
NCT02559206Enrollment759StartOct 2015Primary CompletionSep 2016CompletionSep 2016 - Phase 2Completed
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
IW-3718, Matching Placebo
Gastroesophageal Reflux Disease
NCT02637557Enrollment282StartMar 2016Primary CompletionApr 2017CompletionApr 2017 - Phase 2Completed
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)
NCT03931785Enrollment515StartMay 2019Primary CompletionFeb 2020CompletionMar 2020 - Phase 2Terminated
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
NCT05740007Enrollment98StartMar 2023Primary CompletionJan 2025CompletionFeb 2025 - Phase 1Completed
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
NCT03856970Enrollment87StartMar 2019Primary CompletionJun 2019CompletionJul 2019 - Phase 1Completed
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
IW-3300, Placebo
Healthy Volunteers
NCT05188261Enrollment32StartJan 2022Primary CompletionMar 2022CompletionMar 2022 - Phase 1Completed
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
IW-3300, Placebo
Healthy Volunteers
NCT05362695Enrollment18StartMay 2022Primary CompletionJun 2022CompletionJul 2022
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Terminated | Linaclotide, Placebo | NCT02837783 |
| Phase 4 | Terminated | Lesinurad, XOI | NCT03226899 |
| Phase 3 | Completed | Matching Placebo, Linaclotide | NCT00730015 |
| Phase 3 | Completed | Linaclotide | NCT00730171 |
| Phase 3 | Completed | Linaclotide or Matching Placebo | NCT00938717 |
| Phase 3 | Completed | Linaclotide, Matching Placebo | NCT02291679 |
| Phase 3 | Terminated | IW-3718, placebo | NCT03561090 |
| Phase 3 | Completed | IW-3718, placebo | NCT03561883 |
| Phase 3 | Completed | Linaclotide, Placebo | NCT03573908 |
| Phase 2 | Completed | MD-1100 Acetate | NCT00258193 |
| Phase 2 | Completed | MD-1100 Acetate | NCT00306748 |
| Phase 2 | Completed | linaclotide acetate, Matching placebo | NCT00402337 |
| Phase 2 | Completed | MD-0727 | NCT00404001 |
| Phase 2 | Completed | Linaclotide Acetate, Matching placebo | NCT00460811 |
| Phase 2 | Completed | IW-6118, Matching Placebo | NCT01107236 |
| Phase 2 | Terminated | IW-9179, Placebo | NCT01712412 |
| Phase 2 | Completed | IW-3718, Matching Placebo | NCT02030925 |
| Phase 2 | Completed | IW-9179, Matching Placebo | NCT02289846 |
| Phase 2 | Completed | Linaclotide, Matching Placebo | NCT02559206 |
| Phase 2 | Completed | IW-3718, Matching Placebo | NCT02637557 |
| Phase 2 | Completed | MD-7246, Placebo | NCT03931785 |
| Phase 2 | Terminated | IW-3300 rectal foam, Placebo | NCT05740007 |
| Phase 1 | Completed | Microgestin®, Levothyroxine | NCT03856970 |
| Phase 1 | Completed | IW-3300, Placebo | NCT05188261 |
| Phase 1 | Completed | IW-3300, Placebo | NCT05362695 |