| 2026-08-21 | Trial | New trial registered: MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) | Trial register ClinicalTrials.gov |
| 2026-05-21 | Label | FDA label revised: Linzess (NDA202811) | Regulator FDA drug label register |
| 2026-05-14 | Results | Results posted: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipa | Trial register ClinicalTrials.gov |
| 2026-05-06 | Trial | New trial registered: Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis | Trial register ClinicalTrials.gov |
| 2026-02-25 | Trial | New trial registered: "Efficacy and Safety of Linaclotide in Chronic Constipation" | Trial register ClinicalTrials.gov |
| 2026-01-06 | Results | Results posted: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C | Trial register ClinicalTrials.gov |
| 2026-01-06 | Results | Results posted: A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are | Trial register ClinicalTrials.gov |
| 2025-10-02 | Federal Register | Federal Register notice: Pediatric Advisory Committee (PAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments | Regulator Federal Register |
| 2025-05-25 | Trial | New trial registered: Effect to Linaclotide on Colonic Motility | Trial register ClinicalTrials.gov |
| 2024-12-27 | Trial | New trial registered: Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy | Trial register ClinicalTrials.gov |
| 2024-11-26 | Results | Results posted: Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Con | Trial register ClinicalTrials.gov |
| 2024-11-18 | Trial | New trial registered: Linaclotide for Colonoscopy Bowel Prep | Trial register ClinicalTrials.gov |
| 2023-10-16 | Trial | New trial registered: Clinical Study of Bowel Preparation Before Colonoscopy | Trial register ClinicalTrials.gov |
| 2023-04-03 | Trial | New trial registered: A Study of Virtual Reality and Linaclotide for IBS-C | Trial register ClinicalTrials.gov |
| 2023-03-08 | Trial | New trial registered: A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Wh | Trial register ClinicalTrials.gov |
| 2022-12-15 | Trial | New trial registered: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Co | Trial register ClinicalTrials.gov |
| 2022-05-20 | Federal Register | Federal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Regulator Federal Register |
| 2022-05-18 | Trial | New trial registered: Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation | Trial register ClinicalTrials.gov |
| 2022-04-26 | Results | Results posted: Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation | Trial register ClinicalTrials.gov |
| 2022-03-22 | Trial | New trial registered: Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy | Trial register ClinicalTrials.gov |
| 2021-12-06 | Results | Results posted: A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2021-11-30 | Trial | New trial registered: Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2021-11-26 | Trial | New trial registered: Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders | Trial register ClinicalTrials.gov |
| 2021-11-04 | Trial | New trial registered: GCC Agonist Signal in the Small Intestine | Trial register ClinicalTrials.gov |
| 2021-06-02 | Recall | FDA recall, Class II: Cardinal Health Inc.. CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Regulator FDA enforcement reports |
| 2021-03-18 | Trial | New trial registered: Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation | Trial register ClinicalTrials.gov |
| 2020-12-28 | Results | Results posted: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipati | Trial register ClinicalTrials.gov |
| 2020-11-16 | Results | Results posted: A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2020-08-20 | Trial | New trial registered: HygiRelief Procedure and HygiSample Evaluation for Functional Constipation | Trial register ClinicalTrials.gov |
| 2020-07-08 | Trial | New trial registered: Evaluate the Safety of Linaclotide in IBS-C Patients in China | Trial register ClinicalTrials.gov |
| 2020-04-24 | Results | Results posted: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2019-11-18 | Trial | New trial registered: Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C | Trial register ClinicalTrials.gov |
| 2019-10-01 | Trial | New trial registered: Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation | Trial register ClinicalTrials.gov |
| 2019-08-22 | Results | Results posted: An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndr | Trial register ClinicalTrials.gov |
| 2019-07-19 | Trial | New trial registered: Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Function | Trial register ClinicalTrials.gov |
| 2019-07-02 | Results | Results posted: Efficacy of Linaclotide to Senna for CIC | Trial register ClinicalTrials.gov |
| 2019-05-14 | Results | Results posted: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Chi | Trial register ClinicalTrials.gov |
| 2019-04-08 | Results | Results posted: Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiv | Trial register ClinicalTrials.gov |
| 2019-02-15 | Results | Results posted: An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2019-01-08 | Trial | New trial registered: Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | Trial register ClinicalTrials.gov |
| 2018-12-28 | Federal Register | Federal Register notice: Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability | Regulator Federal Register |
| 2018-06-29 | Trial | New trial registered: A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2018-03-21 | Trial | New trial registered: Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Con | Trial register ClinicalTrials.gov |
| 2018-02-19 | Results | Results posted: An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2017-11-14 | Trial | New trial registered: Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation | Trial register ClinicalTrials.gov |
| 2017-10-25 | Trial | New trial registered: Assessment of Responsiveness to Treatment by Experience Sampling Method | Trial register ClinicalTrials.gov |
| 2017-05-19 | Results | Results posted: Trial of Linaclotide in Patients With Chronic Idiopathic Constipation | Trial register ClinicalTrials.gov |
| 2017-04-18 | Trial | New trial registered: Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2016-11-18 | Trial | New trial registered: A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome | Trial register ClinicalTrials.gov |
| 2016-09-27 | Results | Results posted: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered | Trial register ClinicalTrials.gov |
| 2016-07-20 | Trial | New trial registered: A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2016-06-22 | Trial | New trial registered: A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2016-05-21 | Trial | New trial registered: Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy | Trial register ClinicalTrials.gov |
| 2016-04-26 | Results | Results posted: Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating | Trial register ClinicalTrials.gov |
| 2015-10-29 | Trial | New trial registered: An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel | Trial register ClinicalTrials.gov |
| 2015-09-24 | Trial | New trial registered: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Cons | Trial register ClinicalTrials.gov |
| 2015-09-24 | Trial | New trial registered: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2015-09-24 | Trial | New trial registered: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria f | Trial register ClinicalTrials.gov |
| 2015-06-08 | Trial | New trial registered: Single-dose Linaclotide for Capsule Endoscopy Preparation | Trial register ClinicalTrials.gov |
| 2015-04-07 | Trial | New trial registered: A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2015-02-10 | Trial | New trial registered: Caecal pH as a Biomarker for Irritable Bowel Syndrome | Trial register ClinicalTrials.gov |
| 2014-12-15 | Trial | New trial registered: Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome | Trial register ClinicalTrials.gov |
| 2014-11-14 | Trial | New trial registered: Trial of Linaclotide in Patients With Chronic Idiopathic Constipation | Trial register ClinicalTrials.gov |
| 2014-10-22 | Trial | New trial registered: Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation | Trial register ClinicalTrials.gov |
| 2014-09-12 | Trial | New trial registered: Efficacy of Linaclotide to Senna for CIC | Trial register ClinicalTrials.gov |
| 2014-08-19 | Trial | New trial registered: A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically | Trial register ClinicalTrials.gov |
| 2014-05-23 | Federal Register | Federal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; LINZESS | Regulator Federal Register |
| 2014-03-05 | Trial | New trial registered: Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients | Trial register ClinicalTrials.gov |
| 2013-09-25 | Trial | New trial registered: Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers | Trial register ClinicalTrials.gov |
| 2013-06-19 | Trial | New trial registered: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Adminis | Trial register ClinicalTrials.gov |
| 2013-03-05 | Results | Results posted: Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2013-01-30 | Results | Results posted: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2013-01-30 | Results | Results posted: Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C | Trial register ClinicalTrials.gov |
| 2013-01-30 | Results | Results posted: Trial of Linaclotide in Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2013-01-30 | Results | Results posted: Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2013-01-30 | Results | Results posted: Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2012-10-26 | Trial | New trial registered: A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome | Trial register ClinicalTrials.gov |
| 2012-07-17 | Trial | New trial registered: Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating | Trial register ClinicalTrials.gov |
| 2011-08-31 | Trial | New trial registered: A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects | Trial register ClinicalTrials.gov |
| 2011-01-18 | Trial | New trial registered: A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects | Trial register ClinicalTrials.gov |
| 2009-07-29 | Trial | New trial registered: Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2009-07-14 | Trial | New trial registered: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) | Trial register ClinicalTrials.gov |
| 2008-10-03 | Trial | New trial registered: An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2008-10-03 | Trial | New trial registered: Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2008-08-08 | Trial | New trial registered: An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2008-08-08 | Trial | New trial registered: Trial of Linaclotide in Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2007-04-16 | Trial | New trial registered: Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation | Trial register ClinicalTrials.gov |
| 2006-11-22 | Trial | New trial registered: Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation | Trial register ClinicalTrials.gov |
| 2006-03-20 | Trial | New trial registered: Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation | Trial register ClinicalTrials.gov |
| 2005-11-22 | Trial | New trial registered: Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS | Trial register ClinicalTrials.gov |