Linaclotide

also known as ASP0456 · LINZESS · MD-1100 · Constella · lin · Linaclotida · linaclotide acetate · Lingzeshu · +3 more

Peptide targets GUCY2C via activation

Developed for: constipation disorder · irritable bowel syndrome · colorectal adenoma · colorectal cancer · colorectal carcinoma · dyspepsia · in situ carcinoma · opioid-induced constipation
+1 more
· type 2 diabetes mellitus
Investigated by: Ironwood Pharmaceuticals, Inc. · Forest Laboratories · Astellas Pharma Inc · AbbVie · National Cancer Institute (NCI) · 900th Hospital of PLA Joint Logistic Support Force
+43 more
· Affiliated Hospital of Qinghai University · Affiliated Hospital of Southwest Medical University · Affiliated Yueqing Hospital of Wenzhou Medical University · Allergan · Allergan Sales, LLC · AstraZeneca · Changhai Hospital · Daping Hospital of Army Medical University · Haifeng Lan · Huizhou Municipal Central Hospital · Jiangsu Hansoh Pharmaceutical Co., Ltd. · Jinling Hospital, China · Manchester University NHS Foundation Trust · Mayo Clinic · Md Mehedi Shahriar · Ningxia Medical University General Hospital · Qilu Hospital of Shandong University · RenJi Hospital · Ruijin Hospital · Second Affiliated Hospital of Xi'an Jiaotong University · Second Xiangya Hospital of Central South University · Seventh Medical Center of PLA Army General Hospital · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai Zhongshan Hospital · Shanxi Provincial People's Hospital · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · The Affiliated Hospital of Inner Mongolia Medical University · The Affiliated Hospital of Qingdao University · The First Affiliated Hospital of Nanchang University · The First Affiliated Hospital of Soochow University · The First Hospital of Jilin University · The First Hospital of Shihezi University · The First People's Hospital of Yunnan · The Second Affiliated Hospital of Air Force Military Medical University · The Second Affiliated Hospital of Dalian Medical University · The Second Hospital of Hebei Medical University · The Third Affiliated Hospital of Wenzhou Medical University · United States Department of Defense · University of Florida · University of Nottingham · University of Virginia · University of Wisconsin, Madison · Zunyi Medical College

Regulatory milestones approvals, filings & regulatory actions · 15 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed chronic duodenal ileus 1 milestone
Filed	US (FDA)	—	chronic duodenal ileus	2016-06-09	“FDA has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide” ironwoodpharma.com ↗
Filed irritable bowel syndrome 6 milestones
Filed	China (NMPA)	—	irritable bowel syndrome	2016-05-09	“filed for approval with the China Food and Drug Administration to market linaclotide in China for the treatment of adult patients with IBS-C” ironwoodpharma.com ↗
Filed	Japan (PMDA)	—	irritable bowel syndrome	2016-02-24	“NDA seeking approval of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) in Japan was filed” ironwoodpharma.com ↗
Filed	China (NMPA)	—	irritable bowel syndrome	2016-02-18	“Ironwood and AstraZeneca AB filed for approval with the China Food and Drug Administration to market linaclotide in China for IBS-C.” ironwoodpharma.com ↗
Filed	US (FDA)	—	irritable bowel syndrome	2012-02-08	“Ironwood and Forest submitted the NDA for linaclotide for the treatment of IBS-C and CC” ironwoodpharma.com ↗
Filed	EU (EMA)	—	irritable bowel syndrome	2011-09-29	“Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist” ironwoodpharma.com ↗ “submitted a Market Authorization Application (MAA) for linaclotide to the European Medicines Agency (EMA)” ironwoodpharma.com ↗ “as well as the MAA submission in Europe for the IBS-C indication.” ironwoodpharma.com ↗
Filed	US (FDA)	—	irritable bowel syndrome	2011-08-09	“recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linaclotide” ironwoodpharma.com ↗
Filed outlet dysfunction constipation 1 milestone
Filed	US (FDA)	LINZESS	outlet dysfunction constipation	2022-12-16	“FDA accepted and granted priority review of a supplemental New Drug Application (sNDA) for LINZESS for the treatment of functional constipation (FC)” ironwoodpharma.com ↗ “submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗
Approved Indication not stated 3 milestones
Label expansions (5)	US (FDA)	LINZESS	—	2017-01-25 – 2026-05-21	fda.gov ↗
Approved	EU (EMA)	Constella	—	2012-11-26	europa.eu ↗
Approved	US (FDA)	LINZESS	—	2012-08-30	fda.gov ↗

Trials 42

today

US approved 2012

EU approved 2012

NCT07569419 · Ph 0 NCT07431957 · Ph 4 NCT06692673 · Ph 1/2 NCT06748638 · Ph 4 NCT06091735 · not/applicable NCT05760313 · Ph 2 NCT05652205 · Ph 3 NCT05107219 · Ph 1 NCT05291325 · not/applicable NCT05137145 · not/applicable NCT04804267 · Ph 3 NCT05134584 · Ph 4 NCT03796884 · Ph 2 NCT04110145 · Ph 2 NCT04026113 · Ph 3 NCT03573908 · Ph 3 NCT02837783 · Ph 4 NCT02809105 · Ph 3 NCT02559570 · Ph 2 NCT02559817 · Ph 2 NCT02590432 · Ph 4 NCT02559206 · Ph 2 NCT02425722 · Ph 2 NCT02465385 · Ph 4 NCT02270983 · Ph 2 NCT02316899 · Ph 3 NCT02291679 · Ph 3 NCT02220348 · Ph 1 NCT01950403 · Ph 1 NCT01880424 · Ph 3 NCT01642914 · Ph 3 NCT01714843 · Ph 2 NCT01427387 · Ph 1 NCT01279915 · Ph 1 NCT00938717 · Ph 3 NCT00948818 · Ph 3 NCT00765999 · Ph 3 NCT00730171 · Ph 3 NCT00765882 · Ph 3 NCT00730015 · Ph 3 NCT00306748 · Ph 2 NCT00258193 · Ph 2

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT07569419	Mar → Aug 2026 overdue	cystic fibrosis	University of Nottingham	Recruiting	No outcome recorded
Phase 15 trials
Phase 1	NCT05107219	Nov 2022 → Feb 2026	Barrett esophagus, digestive system cancer, gastroesophageal reflux disease	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 1	NCT02220348	Jul 2014 → May 2019	constipation disorder, irritable bowel syndrome	Forest Laboratories	Completed	No outcome recorded
Phase 1	NCT01950403	Sep 2013 → Apr 2016	colorectal cancer	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT01427387	Jun → Sep 2011	—	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT01279915	Oct 2010 → Jan 2011	—	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06692673	Dec 2025 → Apr 2026 overdue	—	University of Florida	Recruiting	No outcome recorded
Phase 211 trials · 2 met primary · 1 missed
Phase 2	NCT05760313	Apr 2023 → Jun 2025	constipation disorder	AbbVie	Completed	No outcome recorded
Phase 2	NCT03796884	Oct 2019 → Nov 2026 expected	colorectal adenoma, colorectal carcinoma, in situ carcinoma	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	Active not recruiting	No outcome recorded
Phase 2	NCT04110145	Oct 2019 → Apr 2021	constipation disorder	Allergan	Completed	No outcome recorded
Phase 2	NCT02559570	Nov 2015 → Apr 2018	constipation disorder	Forest Laboratories	Completed	Missed primary
Phase 2	NCT02559817	Nov 2015 → Aug 2019	irritable bowel syndrome	Forest Laboratories	Terminated	No outcome recorded
Phase 2	NCT02559206	Oct 2015 → Sep 2016	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	Mixed
Phase 2	NCT02425722	Apr → Oct 2015	constipation disorder	Astellas Pharma Inc	Completed	Met primary
Phase 2	NCT02270983	Oct 2014 → Aug 2015	opioid-induced constipation	Forest Laboratories	Completed	Met primary
Phase 2	NCT01714843	Aug 2012 → Dec 2013	irritable bowel syndrome	Astellas Pharma Inc	Completed	No outcome recorded
Phase 2	NCT00306748	Mar → Aug 2006	constipation disorder	Ironwood Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2	NCT00258193	Jan → Sep 2006	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	No outcome recorded

Phase 315 trials · 10 met primary · 1 missed
Phase 3	NCT05652205	Dec 2022 → Sep 2025	constipation disorder	AbbVie	Completed	Missed primary
Phase 3	NCT04804267	Mar 2021 → Aug 2022	constipation disorder	Jiangsu Hansoh Pharmaceutical Co., Ltd.	Unknown	No outcome recorded
Phase 3	NCT04026113	Oct 2019 → May 2024	constipation disorder, irritable bowel syndrome	AbbVie	Completed	Met primary
Phase 3	NCT03573908	Jun 2018 → Mar 2019	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT02809105	Jun → Nov 2016	constipation disorder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 3	NCT02316899	Oct 2014 → Sep 2015	irritable bowel syndrome	Astellas Pharma Inc	Completed	Met primary
Phase 3	NCT02291679	Oct 2014 → Aug 2015	constipation disorder	Ironwood Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT01880424	Jul 2013 → May 2015	irritable bowel syndrome	AstraZeneca	Completed	Met primary
Phase 3	NCT01642914	Aug 2012 → May 2013	constipation disorder	Forest Laboratories	Completed	Met primary
Phase 3	NCT00938717	Jul 2009 → Sep 2010	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT00948818	Jul 2009 → Jul 2010	irritable bowel syndrome	Forest Laboratories	Completed	Met primary
Phase 3	NCT00765999	Oct 2008 → Jan 2012	constipation disorder, irritable bowel syndrome	Forest Laboratories	Completed	No outcome recorded
Phase 3	NCT00730171	Sep 2008 → Mar 2012	constipation disorder, irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT00765882	Sep 2008 → Jul 2009	constipation disorder	Forest Laboratories	Completed	Met primary
Phase 3	NCT00730015	Aug 2008 → Aug 2009	constipation disorder	Ironwood Pharmaceuticals, Inc.	Completed	Met primary

Phase 46 trials · 1 met primary · 1 missed
Phase 4	NCT07431957	Feb → Dec 2026 expected	constipation disorder, irritable bowel syndrome	Md Mehedi Shahriar	Not yet recruiting	No outcome recorded
Phase 4	NCT06748638	Sep 2024 → Oct 2025 overdue	—	Haifeng Lan	Enrolling by invitation	No outcome recorded
Phase 4	NCT05134584	Jan → Dec 2021	dyspepsia, irritable bowel syndrome	RenJi Hospital	Unknown	Met primary
Phase 4	NCT02837783	Dec 2016 → Oct 2018	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Terminated	Missed primary Stop: Enrollment
Phase 4	NCT02590432	Nov 2015 → Feb 2018	constipation disorder, irritable bowel syndrome	Forest Laboratories	Completed	No outcome recorded
Phase 4	NCT02465385	Feb 2015 → Jun 2016	Crohn disease, ulcerative colitis	University of Virginia	Completed	No outcome recorded
Phase not applicable3 trials · 2 met primary
—	NCT06091735	Aug 2023 → Feb 2024	—	Jinling Hospital, China	Completed	No outcome recorded
—	NCT05291325	May 2022 → Aug 2023	—	Changhai Hospital	Completed	Met primary
—	NCT05137145	Sep 2021 → Mar 2022	—	Second Affiliated Hospital of Xi'an Jiaotong University	Unknown	Met primary
Comparator or background therapy9 trials
Phase 2	NCT00460811 Comparator	Apr 2007 → Feb 2008	irritable bowel syndrome	Ironwood Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2	NCT00402337 Comparator	Nov 2006 → Dec 2007	constipation disorder	Ironwood Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT04166058 Comparator	Nov 2019 → Jun 2025	constipation disorder, irritable bowel syndrome	AbbVie	Completed	No outcome recorded
Phase 4	NCT03119584 Comparator	Sep 2015 → Oct 2026 expected	constipation disorder, type 2 diabetes mellitus	Texas Tech University Health Sciences Center, El Paso	Active not recruiting	No outcome recorded
Phase 4	NCT06989268 Comparator	Feb 2014 → Feb 2015	constipation disorder	Universitaire Ziekenhuizen KU Leuven	Completed	No outcome recorded
—	NCT05379491 Comparator	Aug 2022 → Jun 2023	—	Zhiguo Liu	Completed	No outcome recorded
—	NCT02360384 Comparator	Nov 2015 → Dec 2016	irritable bowel syndrome	Wingate Institute of Neurogastroenterology	Unknown	No outcome recorded
—	NCT02239510 Comparator	Sep 2014 → Jun 2016	constipation disorder	TriHealth Inc.	Terminated	No outcome recorded Stop: Enrollment
—	NCT02078323 Comparator	Feb 2014 → Oct 2017	irritable bowel syndrome	Augusta University	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 49

Date	Issuer	Release
2026-05-27	Ironwood Pharmaceuticals, Inc.	Regulatory FDA Approves Use of LINZESS® (linaclotide) in Pediatric Patients Two Years of Age and Older with Functional Constipation (FC) ironwoodpharma.com ↗ today announced that the U.S. Food and Drug Administration (FDA) has approved the use of LINZESS ® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC).
2024-05-21	Ironwood Pharmaceuticals, Inc.	Results Ironwood Late-Breaker Oral Presentation at Digestive Disease Week® Reinforces Potential of Once-Weekly Apraglutide for Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF) ironwoodpharma.com ↗ Treatment-emergent adverse events were similar in both age groups and were consistent with the known safety profile of linaclotide in patients with IBS-C.
2024-01-08	Ironwood Pharmaceuticals, Inc.	Results Ironwood Announces Publication in The Lancet Gastroenterology & Hepatology of New Linaclotide Phase III Data in Children and Adolescents Aged 6-17 Years with Functional Constipation ironwoodpharma.com ↗ A greater percentage of patients in the linaclotide treatment group were weekly SBM responders (patients who had an increase ≥2 in the SBM weekly rate from baseline for that week) compared with the placebo group at weeks 1, 3, 4, 6, 7, 11, and 12 (p < 0·05).
2023-10-23	Ironwood Pharmaceuticals, Inc.	Results Ironwood Releases New IBS-C and CIC Data at the American College of Gastroenterology 2023 Annual Scientific Meeting ironwoodpharma.com ↗ These data provide further insight into the impact of linaclotide on symptoms of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), as well as the burden of these disorders on patients.
2023-10-05	Ironwood Pharmaceuticals, Inc.	Results Ironwood to Present New Data at NASPGHAN Annual Meeting Reinforcing Impact of Linaclotide on Functional Constipation in Children and Adolescents Ages 6-17 Years-Old ironwoodpharma.com ↗ The post-hoc analysis demonstrated that in pediatric patients with functional constipation, diarrhea occurred in 7.4 percent of the linaclotide-treated population and 1.5 percent of those receiving placebo.
2023-06-12	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces FDA Approval of New Indication for LINZESS® (linaclotide) for the Treatment of Functional Constipation in Pediatric Patients Ages 6-17 Years-Old ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved LINZESS® (linaclotide) as a once-daily treatment for pediatric patients ages 6-17 years-old with functional constipation.
2023-05-08	Ironwood Pharmaceuticals, Inc.	Results Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week® 2023 ironwoodpharma.com ↗ Linaclotide was generally well-tolerated and exhibited a safety profile consistent with a prior pediatric Phase II study in functional constipation.
2023-02-13	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of Supplemental New Drug Application for LINZESS® (linaclotide) for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for LINZESS ® (linaclotide) for the treatment of children and adolescents ages 6-17 years-old with functional constipation (FC).
2022-12-16	AbbVie	Regulatory AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESS® (linaclotide) for Functional Constipation in Children and Adolescents 6 to 17 Years of Age abbvie.com ↗ AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC).
2022-09-06	Ironwood Pharmaceuticals, Inc.	Results Ironwood Pharmaceuticals Reports Positive Topline Data from Phase III Trial of LINZESS® (linaclotide) in Pediatric Patients Aged 6-17 with Functional Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), today announced positive topline data from a Phase III clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC).
2021-08-26	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces FDA Approval of Revised LINZESS® (linaclotide) Label ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for LINZESS ® (linaclotide) based on clinical safety data that has been generated thus far in pediatric studies.
2021-06-16	Ironwood Pharmaceuticals, Inc.	Results Ironwood Pharmaceuticals Announces That The American Journal of Gastroenterology Publishes Full Results from Positive LINZESS® (linaclotide) Phase IIIb Trial in Adults with Irritable Bowel Syndrome with Constipation (IBS-C) ironwoodpharma.com ↗ The results, which can be viewed here , demonstrated that linaclotide 290 mcg administered orally once daily to adult IBS-C patients was associated with a statistically significant and clinically meaningful improvement in overall change in abdominal score compared to placebo.
2021-05-24	Ironwood Pharmaceuticals, Inc.	Results More Than a Third of Surveyed IBS-C Patients Reported That Their Symptoms Worsened During COVID-19 According to New Survey Findings Presented by Ironwood Pharmaceuticals at Digestive Disease Week® (DDW) ironwoodpharma.com ↗
2019-06-18	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Allergan Report Positive Topline Data from Phase IIIb Trial of LINZESS® (linaclotide) in Adults with Irritable Bowel Syndrome with Constipation (IBS-C) ironwoodpharma.com ↗ The trial met its primary multi-component endpoint and demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients compared to placebo.
2019-01-18	AstraZeneca	Regulatory Linzess (linaclotide) approved in China for the treatment of irritable bowel syndrome with constipation astrazeneca.com ↗ Linzess is a first-in-class guanylate cyclase‐C (GC‐C) receptor agonist and the approval offers an important treatment option for adult patients in China.
2019-01-15	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces Approval of LINZESS® (linaclotide) in China for the Treatment of Adults with IBS-C ironwoodpharma.com ↗
2018-08-21	Astellas Pharma Inc	Regulatory Approval of Linzess® Tablets 0.25 mg in Japan for Additional Indication of Chronic Constipation astellas.com ↗ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD , “Ironwood”) today announced that approval has been obtained in Japan for the guanylate cyclase-C receptor agonist “Linzess® Tablets 0.25 mg (generic name: linaclotide)” for the additional indication of chronic constipation (other than constipation associated with organic disorders1) (“chronic constipation”).
2018-08-21	Ironwood Pharmaceuticals, Inc.	Regulatory Approval of Linzess® Tablets 0.25 mg in Japan for Additional Indication of Chronic Constipation ironwoodpharma.com ↗ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa , Ph.D., “Astellas” ) and Ironwood Pharmaceuticals, Inc (Nasdaq: IRWD , “Ironwood”) today announced that approval has been obtained in Japan for the guanylate cyclase-C receptor agonist “Linzess ® Tablets 0.25 mg (generic name: linaclotide)” for the additional indication of chronic constipation (other than constipation associated with organic disorders 1 ) (“chronic constipation”).
2017-09-11	Astellas Pharma Inc	Regulatory Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of “Linaclotide" for Patients with Chronic Constipation in Japan astellas.com ↗
2017-05-09	Ironwood Pharmaceuticals, Inc.	Results Ironwood Pharmaceuticals Presents Data Further Elucidating Linaclotide's Effect on Pain at Digestive Disease Week® 2017 ironwoodpharma.com ↗
2017-01-30	Astellas Pharma Inc	Results Astellas and Ironwood Report Positive Top-Line Results from Phase III Linaclotide Trial for Patients with Chronic Constipation Conducted in Japan astellas.com ↗ Astellas Pharma Inc. (TSE: 4503) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today top-line results indicating that the Phase III clinical trial of linaclotide conducted in Japan in adults with chronic constipation (CC) met its primary endpoint.
2017-01-29	Ironwood Pharmaceuticals, Inc.	Results Astellas and Ironwood Report Positive Top-Line Results from Phase III Linaclotide Trial for Patients with Chronic Constipation Conducted in Japan ironwoodpharma.com ↗ The top-line trial results indicate that linaclotide-treated patients showed statistically significant improvement compared to placebo-treated patients for the primary endpoint, change from baseline in mean spontaneous bowel movement frequency at Week 1.
2017-01-26	Ironwood Pharmaceuticals, Inc.	Regulatory U.S. Food and Drug Administration Approves 72 mcg Dose of LINZESS® (linaclotide) for Adults with Chronic Idiopathic Constipation ironwoodpharma.com ↗ LINZESS is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults with CIC.
2016-12-22	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Allergan Report Topline Phase IIb Data Supporting Further Investigation of Linaclotide Colonic Release-2 (CR2) for Abdominal Pain in Non-Constipation Subtypes of IBS ironwoodpharma.com ↗ The data showed that CR2, as intended, numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no apparent effect on bowel movement function.
2016-12-22	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Allergan Report Topline Phase IIb Data Supporting Advancement of Linaclotide Colonic Release-1 (CR1) in IBS-C ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Allergan plc (NYSE:AGN) announced today positive topline data from a Phase IIb clinical trial evaluating the investigational linaclotide colonic release-1 (CR1) formulation in adult patients with irritable bowel syndrome with constipation (IBS-C).
2016-12-19	Astellas Pharma Inc	Regulatory Marketing Approval of LINZESS®, Treatment for Irritable Bowel Syndrome with Constipation in Japan - Provides a new therapeutic option for adult patients suffering from irritable bowel syndrome with constipation (IBS-C) - astellas.com ↗ Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced that it obtained a marketing approval for a guanylate cyclase-C (GC-C) receptor agonist, LINZESS ® (generic name: linaclotide Development Code: ASP0456) for irritable bowel syndrome with constipation1) (IBS-C) in adults by the Ministry of Health, Labour and Welfare in Japan today.
2016-12-19	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces Approval of LINZESS® (linaclotide) in Japan for the Treatment of Adults with IBS-C ironwoodpharma.com ↗ Today's news is particularly significant for these patients who, until now, did not have a prescription medicine approved to treat the recurring symptoms associated with IBS-C.
2016-06-09	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood and Allergan Announce Supplemental New Drug Application for 72 mcg Linaclotide in Chronic Idiopathic Constipation Has Been Accepted for FDA Review ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. ( NASDAQ : IRWD) and Allergan plc ( NYSE : AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC).
2016-02-24	Astellas Pharma Inc	Regulatory Astellas Submits New Drug Application for Linaclotide, Treatment for Irritable Bowel Syndrome with Constipation, in Japan astellas.com ↗ Astellas Submits New Drug Application for Linaclotide, Treatment for Irritable Bowel Syndrome with Constipation, in Japan
2016-02-24	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Pharmaceuticals Announces Filing by Astellas of New Drug Application in Japan with Linaclotide for the Treatment of Adults with IBS-C ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. ( NASDAQ : IRWD) today announced that a new drug application (NDA) seeking approval of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) in Japan was filed with the Japanese Ministry of Health, Labor and Welfare by Astellas Pharma Inc., Ironwood's partner for linaclotide in Japan.
2015-11-30	Ironwood Pharmaceuticals, Inc.	Results Ironwood Reports Positive Top-Line Data from Phase II Trial of Linaclotide in Adult Patients With Opioid-Induced Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. ( NASDAQ : IRWD) announced today that the Phase II clinical trial of linaclotide conducted in adults with opioid-induced constipation (OIC) met its primary endpoint.
2015-11-30	Ironwood Pharmaceuticals, Inc.	Results Astellas and Ironwood Report Positive Top-Line Data from Phase III IBS-C Trial Conducted in Japan ironwoodpharma.com ↗
2015-10-13	Ironwood Pharmaceuticals, Inc.	Results Ironwood Reports Positive Top-Line Results from Phase III Trial of 72 mcg Linaclotide in Adults with Chronic Idiopathic Constipation ironwoodpharma.com ↗ Top-line data from the Phase III trial indicate that the 72 mcg dose of linaclotide demonstrated statistically significant improvement compared to placebo on the 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder endpoint, the primary endpoint for the trial.
2015-07-08	Ironwood Pharmaceuticals, Inc.	Results AstraZeneca and Ironwood Report Positive Top-Line Data from Phase III IBS-C Trial Designed to Support Linaclotide Approval in China ironwoodpharma.com ↗ Linaclotide has now met all primary and secondary endpoints in all six of its Phase III/IIIb trials.
2015-05-13	Ironwood Pharmaceuticals, Inc.	Results Ironwood Presents Gastrointestinal Disease Research at Digestive Disease Week® 2015 ironwoodpharma.com ↗ Chronic Activation of the GC-C/cGMP Pathway by Linaclotide Inhibits Ascending Nociceptive Pathways and Restores Aberrant Spinal Cord Signaling
2012-11-28	Ironwood Pharmaceuticals, Inc.	Regulatory Constella® (linaclotide) Approved in Europe for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults ironwoodpharma.com ↗ Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the European Commission has granted marketing authorization to Constella ® (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
2012-09-21	Ironwood Pharmaceuticals, Inc.	Regulatory Linaclotide Receives Positive CHMP Opinion for the Treatment of IBS-C ironwoodpharma.com ↗
2012-08-30	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood and Forest Announce FDA Approval of LINZESS™ (Linaclotide) for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™ (linaclotide) was approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
2012-04-23	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood and Forest Announce FDA Has Extended the Review Period for Linaclotide to September 2012 ironwoodpharma.com ↗ Since this analysis was submitted to the FDA within three months of the user fee goal date, the date has been extended by three months, in accordance with applicable regulation.
2012-02-08	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for Linaclotide ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an advisory committee meeting in connection with the its review of the New Drug Application (NDA) for linaclotide proposed for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
2011-10-24	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood and Forest Announce Linaclotide New Drug Application for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Constipation Accepted for FDA Review ironwoodpharma.com ↗
2011-09-29	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood Announces Linaclotide European Regulatory Submission for the Treatment of Irritable Bowel Syndrome with Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation (IBS-C).
2011-08-09	Ironwood Pharmaceuticals, Inc.	Regulatory Ironwood and Forest Announce Submission of New Drug Application for Linaclotide for the Treatment of Irritable Bowel Syndrome With Constipation and Chronic Constipation ironwoodpharma.com ↗
2010-11-01	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Forest Announce Positive Linaclotide Results from Second Phase 3 Trial in Patients with Irritable Bowel Syndrome with Constipation ironwoodpharma.com ↗ Additionally, at each of the 26 weeks in the treatment period, mean changes from baseline in abdominal pain and CSBMs showed statistically significant improvements (p < 0.0001) for linaclotide-treated patients compared to placebo-treated patients.
2010-11-01	Ironwood Pharmaceuticals, Inc.	Results Almirall and Ironwood Announce Positive Results from the Second Phase 3 Trial of Linaclotide in Patients with Irritable Bowel Syndrome with Constipation ironwoodpharma.com ↗ Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced positive top-line results from a 26-week pivotal Phase 3 clinical trial assessing the efficacy and safety of once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome with constipation (IBS-C).
2010-09-13	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Forest Announce Positive Linaclotide Results from Phase 3 Trial in Patients with Irritable Bowel Syndrome with Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).
2010-09-13	Ironwood Pharmaceuticals, Inc.	Results Almirall and Ironwood Announce Positive Results from a Phase 3 Trial with Linaclotide in Patients with Irritable Bowel Syndrome with Constipation ironwoodpharma.com ↗ Top-line results of the phase 3 study with linaclotide show that both primary and main secondary endpoints were met and was well tolerated.
2009-11-02	Ironwood Pharmaceuticals, Inc.	Results Ironwood and Forest Announce Positive Linaclotide Results from Two Pivotal Phase 3 Trials In Patients with Chronic Constipation ironwoodpharma.com ↗ Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC).
2009-05-31	Ironwood Pharmaceuticals, Inc.	Results Ironwood And Forest Present Additional Positive Phase 2b Study Results For Linaclotide In Patients With Irritable Bowel Syndrome With Constipation ironwoodpharma.com ↗ These additional analyses demonstrated that patients treated with linaclotide experienced a statistically significant improvement in abdominal symptoms, bowel habits, and global assessments within the first week of treatment.

All press releases naming this drug 102 releases

Date	Issuer	Release
Show all 102 releases opens the full record — a long page

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 55 sources stand behind the page.

Field	Value	Cited text
Known as	Linaclotide	“The purpose of this study was to evaluate dose response of the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years.” NCT02559570 ↗ 44 “The observation group 1 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine” NCT05137145 ↗ “Magnesium sulfate sodium potassium solution + linaclotide group: 3L sodium magnesium sulfate potassium oral concentrated solution + linaclotide 290μg.” NCT06091735 ↗ “Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg.” NCT04166058 ↗ NCT04026113 ↗ NCT02837783 ↗ NCT05107219 ↗ NCT01714843 ↗ NCT05379491 ↗ NCT00730015 ↗ NCT01950403 ↗ Show 34 more sources
Known as	ASP0456	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01279915 ↗ 2 NCT01427387 ↗ NCT02425722 ↗
Known as	Constella	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301675 ↗
Known as	lin	“This study aimed to evaluate the bowel cleansing efficacy and safety of polyethylene glycol (PEG) combined with linaclotide (lin) for colonoscopy in patients with chronic...” PMID 38713137 ↗ Jun 2024
Known as	Linaclotida	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301675 ↗
Known as	linaclotide acetate	“To assess the pharmacodynamic effect (PD) of linaclotide (linaclotide acetate) (single daily dose x 7 days, stage I cohort dose= 0.870 mg/day) on cyclic guanosine monophosphate...” NCT01950403 ↗
Known as	Lingzeshu	“Lactulose+ linaclotide 290μg (linaclotide capsule, Lingzeshu, 290ug/ capsule, 7 capsules/box) :” NCT06748638 ↗
Known as	LINZESS	“LINZESS® Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily” NCT04804267 ↗ 1 NCT02239510 ↗
Known as	MD-1100	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00306748 ↗ 1 NCT00258193 ↗
Known as	MD-1100 ACETATE	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301675 ↗
Known as	MD-7246 (DELAYED RELEASE FORMULATION)	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301675 ↗
Known as	MM-416775	ChEMBL registry synonym — accepted as the source's own label CHEMBL3301675 ↗
Action	Activate	“Linaclotide is a minimally absorbed peptide agonist of the guanylate cyclase-C receptor that stimulates intestinal fluid secretion and transit and reduces pain in animal models.” PMID 20045700 ↗ Jan 2010 1 “Heat-stable enterotoxin receptor agonist” CHEMBL3301675 ↗
Modality	Peptide	“Linaclotide, a minimally absorbed, 14-amino acid peptide agonist of guanylate cyclase-C” PMID 20801122 ↗ Aug 2010
Route	Oral	“Oral MD-1100 Acetate Administered for 14 Days” NCT00306748 ↗
Target	GUCY2C	“Heat-stable enterotoxin receptor agonist” CHEMBL3301675 ↗