Drugs / Linaclotide
Linaclotide
also known as
ASP0456 · LINZESS · MD-1100 · Constella · lin · Linaclotida · linaclotide acetate · Lingzeshu · +3 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2 | NCT05760313 | Apr 2023 → Jun 2025 | constipation disorder | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT03796884 | Oct 2019 → Jun 2026 overdue | 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT02425722 | Apr → Oct 2015 | constipation disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT02270983 | Oct 2014 → Aug 2015 | opioid-induced constipation | Forest Laboratories | Completed | No outcome recorded |
| 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 | ||||||
| Phase 3 | NCT05652205 | Dec 2022 → Sep 2025 | constipation disorder | AbbVie | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03573908 | Jun 2018 → Mar 2019 | irritable bowel syndrome | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02291679 | Oct 2014 → Aug 2015 | constipation disorder | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01880424 | Jul 2013 → May 2015 | irritable bowel syndrome | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01642914 | Aug 2012 → May 2013 | constipation disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00948818 | Jul 2009 → Jul 2010 | irritable bowel syndrome | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00938717 | Jul 2009 → Sep 2010 | irritable bowel syndrome | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00765999 | Oct 2008 → Jan 2012 | constipation disorder, irritable bowel syndrome | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00765882 | Sep 2008 → Jul 2009 | constipation disorder | 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 | NCT00730015 | Aug 2008 → Aug 2009 | constipation disorder | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT02837783 | Dec 2016 → Oct 2018 | irritable bowel syndrome | Ironwood Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| 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 | ||||||
| — | NCT06091735 | Aug 2023 → Feb 2024 | — | Jinling Hospital, China | Completed | No outcome recorded |
| — | NCT05291325 | May 2022 → Aug 2023 | — | Changhai Hospital | Completed | No outcome recorded |
| — | NCT05137145 | Sep 2021 → Mar 2022 | — | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 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 31 trial | ||||||
| Phase 3 | NCT04166058 Comparator | Nov 2019 → Jun 2025 | constipation disorder, irritable bowel syndrome | AbbVie | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| 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 |
| Phase not applicable4 trials | ||||||
| — | 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 |
| — | NCT02078323 Comparator | Feb 2014 → Oct 2017 | irritable bowel syndrome | Augusta University | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-12-16 | AbbVie | 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 ↗ |
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 ↗ |
| Known as | ASP0456 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01279915 ↗ |
| 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 ↗ |
| Known as | MD-1100 | ClinicalTrials.gov intervention name — accepted as the source's own label 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 20101“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 ↗ |