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Clinical trials
catalyst calendar across sponsors →Studies where IRWD is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
25 interventional · 16 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain SyndromeNCT05740007Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12Randomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business decision | Drug: IW-3300 rectal foam, Placebo | Interstitial Cystitis, Bladder Pain Syndrome | 98 | 2025-01-23actual | 2025-02-28 |
| A Study of Multiple-ascending Doses of IW-3300 in Healthy SubjectsNCT05362695results2024-02-02Incidence of Treatment-Emergent Adverse Events (TEAEs)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: IW-3300, Placebo | Healthy Volunteers | 18 | 2022-06-30actual | 2024-02-02 |
| A Study of Single Ascending Doses of IW-3300 in Healthy VolunteersNCT05188261results2023-12-08Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: IW-3300, Placebo | Healthy Volunteers | 32 | 2022-03-09actual | 2023-12-08 |
| A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)NCT03561090results2021-08-18Change From Baseline in WHSS at Week 8Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Parallel IW-3718 Phase III trial did not meet pre-specified criteria. | Drug: IW-3718, placebo, Standard-dose PPIs QD | Gastroesophageal Reflux Disease (GERD) | 495 | 2020-10-07actual | 2021-08-19 |
| Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)NCT03561883results2021-08-18Change From Baseline in WHSS at Week 8Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: IW-3718, placebo, Standard-dose PPIs QD | Gastroesophageal Reflux Disease (GERD) | 609 | 2020-07-28actual | 2021-08-18 |
| A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel SyndromeNCT03931785results2021-03-12Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment PeriodRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: MD-7246, Placebo | Irritable Bowel Syndrome With Diarrhea (IBS-D) | 515 | 2020-02-26actual | 2021-03-12 |
| Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult VolunteersNCT03856970PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Microgestin®, Levothyroxine, Glyburide, Digoxin, IW-3718 | Healthy Volunteers | 87 | 2019-06-25actual | 2019-07-29 |
| A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT03573908results2020-11-16Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment PeriodRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Linaclotide, Placebo | Irritable Bowel Syndrome Characterized by Constipation | 614 | 2019-03-13actual | 2020-12-01 |
| A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal ImpairmentNCT03226899results2021-11-04Percentage of Participants Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Terminatedsponsor's stated reason: This action was a business decision \& not related to any efficacy, safety or clinical concerns with lesinurad. | Drug: Lesinurad, XOI, Placebo, colchicine, corticosteroids | Gout, Chronic Kidney Disease (CKD) | 242 | 2019-02-25actual | 2021-11-04 |
| A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)NCT02837783results2021-12-06Change From Baseline in Abdominal Girth at Week 4Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Terminatedsponsor's stated reason: Insufficient enrollment | Drug: Linaclotide, Placebo | Irritable Bowel Syndrome Characterized by Constipation | 20 | 2018-10-31actual | 2021-12-06 |
| A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)NCT02637557results2019-10-15Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)Randomized · Double-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: IW-3718, Matching Placebo, PPI | Gastroesophageal Reflux Disease | 282 | 2017-04-26actual | 2019-10-15 |
| Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT02559206results2020-04-24Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. PlaceboRandomized · Quadruple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: Linaclotide, Matching Placebo | Irritable Bowel Syndrome With Constipation | 759 | 2016-09-30actual | 2020-04-24 |
| Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)NCT02289846Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis SymptomsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: IW-9179, Matching Placebo | Diabetic Gastroparesis | 90 | Dec 2015actual | 2016-12-05 |
| Trial of Linaclotide in Patients With Chronic Idiopathic ConstipationNCT02291679results2017-05-19Percentage of 12-Week CSBM Overall RespondersRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Linaclotide, Matching Placebo | Chronic Idiopathic Constipation | 1,223 | Aug 2015actual | 2017-06-15 |
| Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump InhibitorsNCT02030925Exploratory Endpoints - GERD SymptomsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: IW-3718, Matching Placebo | Gastroesophageal Reflux | 93 | Dec 2014actual | 2016-08-01 |
| Phase 2a Study of IW-9179 to Treat Functional DyspepsiaNCT01712412Rate of treatment-emergent adverse eventsRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Slow enrollment | Drug: IW-9179, Placebo | Dyspepsia, Functional Gastrointestinal Disorders | 10 | Feb 2014actual | 2014-03-19 |
| An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With ConstipationNCT00730171results2018-02-19Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)Open-label · Treatment | Phase 3 | Completed | Drug: Linaclotide | Irritable Bowel Syndrome With Constipation, Chronic Constipation | 1,743 | Mar 2012actual | 2018-02-19 |
| Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT00938717results2013-01-30Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 WeeksRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Linaclotide or Matching Placebo | Irritable Bowel Syndrome With Constipation | 805 | Sep 2010actual | 2013-11-05 |
| Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar ExtractionNCT01107236Safety AssessmentsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: IW-6118, Matching Placebo, Naproxen Sodium | Healthy | 90 | Aug 2010actual | 2022-08-11 |
| Trial of Linaclotide in Patients With Chronic ConstipationNCT00730015results2013-01-30Complete Spontaneous Bowel Movement (CSBM) Overall ResponderRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Matching Placebo, Linaclotide | Chronic Constipation | 643 | Aug 2009actual | 2013-01-30 |
| Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)NCT00460811results2013-01-30Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Linaclotide Acetate, Matching placebo | Irritable Bowel Syndrome With Constipation | 420 | Feb 2008actual | 2013-02-04 |
| Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic ConstipationNCT00402337results2013-03-05Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) FrequencyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: linaclotide acetate, Matching placebo | Chronic Constipation | 310 | Dec 2007actual | 2013-03-05 |
| Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBSNCT00258193(Safety) AEs to be collected beginning with patient's first administration of study medication through final study visitRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: MD-1100 Acetate | Irritable Bowel Syndrome | 36 | — | 2006-10-20 |
| Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic ConstipationNCT00306748Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: MD-1100 Acetate | Constipation | 40 | — | 2009-03-24 |
| Study of Oral MD-0727 Administered to Patients With Primary HypercholesterolemiaNCT00404001Low density lipoprotein cholesterol (LDL-C)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: MD-0727 | Hypercholesterolemia | 150 | — | 2007-10-01 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19