Drugs / Colesevelam
Colesevelam
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | US (FDA) | WelChol | type 2 diabetes mellitus | 2007-01-02 | “filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for WelChol®” daiichisankyo.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | WELCHOL | — | 2006-09-06 – 2021-10-20 | fda.gov ↗ |
| Approved | EU (EMA) | Cholestagel | — | 2004-03-09 | europa.eu ↗ |
| Approved | US (FDA) | WELCHOL | — | 2000-05-26 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06925997 | May 2024 → Dec 2027 expected | glucose metabolism disease | Hvidovre University Hospital | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03856970 | Mar → Jun 2019 | — | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00692250 | Sep → Dec 2007 | — | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06197763 | Jun 2024 → Nov 2025 | congenital cardiovascular shunt | St. Boniface Hospital | Unknown | No outcome recorded |
| Phase 28 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07592858 | Jul 2026 → Apr 2029 expected | hyperlipidemia | University of Rhode Island | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05252988 | Aug 2022 → Oct 2024 overdue | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03767257 | Dec 2018 → Nov 2024 | diarrheal disease, plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02637557 | Mar 2016 → Apr 2017 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT02030925 | Feb → Dec 2014 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01066364 | Feb 2010 → Feb 2012 | metabolic dysfunction-associated steatohepatitis | University of California, San Diego | Completed | No outcome recorded |
| Phase 2 | NCT00911612 | Jan → May 2009 | diarrheal disease, irritable bowel syndrome | Mayo Clinic | Completed | Mixed |
| Phase 2 | NCT00147745 | Jun 2005 → Jan 2008 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Missed primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00756171 | Sep 2008 → May 2009 | liver disorder | Foundation for Liver Research | Completed | Missed primary |
| Phase 311 trials · 6 met primary · 2 missed | ||||||
| Phase 3 | NCT03561883 | Sep 2018 → Jul 2020 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 3 | NCT03561090 | Jun 2018 → Oct 2020 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT00990184 | Sep 2009 → Oct 2010 | prediabetes syndrome | Seattle Institute for Biomedical and Clinical Research | Completed | No outcome recorded |
| Phase 3 | NCT00789750 | Apr 2009 → Jul 2012 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00789737 | Jan 2009 → Dec 2011 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00570739 | Nov 2007 → Apr 2009 | hyperlipidemia, prediabetes syndrome, type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00484419 | May 2007 → Apr 2008 | hyperlipidemia, type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00151762 | Dec 2004 → Jul 2007 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00147719 | Jun 2004 → Jul 2006 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00147758 | Jun 2004 → Aug 2006 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00151749 | Jun 2004 → Dec 2005 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Met primary |
| Phase 418 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT03876717 | Oct 2018 → Jul 2021 | bile acid malabsorption, primary, 1, chronic diarrheal disease | Lars Kristian Munck | Completed | Met primary |
| Phase 4 | NCT02952963 | Oct 2016 → Dec 2017 | morbid obesity | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02876484 | Jun 2016 → Jun 2017 | morbid obesity | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03009916 | Mar 2016 → Aug 2017 | disorder of metabolite absorption and transport | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT02682680 | Jan 2016 → May 2017 | type 2 diabetes mellitus | LMC Diabetes & Endocrinology Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02111603 | Apr → Aug 2014 | irritable bowel syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02050074 | Jan → Sep 2014 | type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT01258075 | Feb 2011 → Nov 2019 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | Missed primary |
| Phase 4 | NCT01239004 | Nov 2010 → Aug 2011 | hyperglycemia, hyperlipidemia | Radiant Research | Completed | No outcome recorded |
| Phase 4 | NCT00951899 | Aug 2009 → Jul 2012 | type 2 diabetes mellitus | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00655265 | Aug 2007 → Dec 2008 | familial hypercholesterolemia | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00145574 | Nov 2005 → Dec 2007 | familial hypercholesterolemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00185107 | Mar → Oct 2005 | familial hypercholesterolemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00754039 | Feb → Sep 2003 | familial hyperlipidemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00754507 | Nov 2002 → Jun 2003 | hyperlipidemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00755352 | Nov 2002 → Jun 2003 | hyperlipidemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00753779 | Nov 2002 → Jun 2003 | hyperlipoproteinemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00715273 | May 2001 → Dec 2018 | atherosclerosis, carotid artery disorder, coronary artery disorder | University of Washington | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 met primary · 1 missed | ||||||
| — | NCT04003181 | Sep 2017 → May 2021 | colon adenocarcinoma, diarrheal disease | University of Aarhus | Completed | No outcome recorded |
| — | NCT01666223 | Nov 2012 → Jun 2013 | obesity disorder, type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT01656057 | Jul 2012 → Oct 2013 | — | Filip Krag Knop | Completed | Met primary |
| — | NCT00938405 | Jul → Dec 2009 | hyperlipidemia, type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00596427 | Nov 2007 → Apr 2009 | type 2 diabetes mellitus | Carine Beysen | Completed | Missed primary |
| Comparator or background therapy13 trials | ||||||
| Phase 1/2 | NCT07226440 Comparator | Mar 2026 → Dec 2028 expected | occupational disorder, poisoning | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT03270085 Comparator | Dec 2017 → May 2019 | chronic diarrheal disease, irritable bowel syndrome, malabsorption syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT02619812 Comparator | Apr → Dec 2016 | plasma cell myeloma | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00690937 Comparator | Feb → Dec 2008 | hyperlipidemia | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00361153 Comparator | May → Oct 2006 | type 2 diabetes mellitus | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2/3 | NCT00993824 Comparator | Sep 2009 → Sep 2011 | type 2 diabetes mellitus | HealthPartners Institute | Completed | No outcome recorded |
| Phase 3 | NCT02628626 Comparator | Nov 2015 → Apr 2022 | malabsorption syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03955575 Comparator | Mar 2019 → Mar 2021 | malabsorption syndrome | Filip Krag Knop | Completed | No outcome recorded |
| Phase 4 | NCT01203254 Comparator | Oct 2010 → Mar 2013 | Crohn disease, malabsorption syndrome | Florian Beigel | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01122108 Comparator | Apr → Jun 2010 | — | Louisville Metabolic and Atherosclerosis Research Center | Completed | No outcome recorded |
| Phase 4 | NCT00249938 Background | Mar 2005 → Aug 2006 | hyperlipidemia | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01948648 Comparator | Feb 2018 → Apr 2021 | sitosterolemia | University of Manitoba | Unknown | No outcome recorded |
| — | NCT01092663 Comparator | Mar 2010 → Jul 2011 | type 2 diabetes mellitus | KineMed | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2020-09-29 | Ironwood Pharmaceuticals, Inc. | Results Ironwood to Discontinue IW-3718 Development Program Following Results from Planned Efficacy Assessment ironwoodpharma.com ↗
Following the assessment from an independent data monitoring committee, Ironwood unblinded the data and confirmed that IW-3718-302 did not meet the criteria, including the study’s primary endpoint of achieving a statistically significant improvement in heartburn severity. |
| 2020-08-06 | Ironwood Pharmaceuticals, Inc. | Regulatory Ironwood Pharmaceuticals Reports Second Quarter 2020 Results; Delivered GAAP Net Income of $25 Million and Adjusted EBITDA of $33 Million ironwoodpharma.com ↗
FDA indicated that long-term safety study for IW-3718 is not required for an NDA submission |
| 2020-02-26 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology ironwoodpharma.com ↗
Additionally, more than 50 percent of patients treated with IW-3718 1500 mg BID plus a PPI reported a clinically meaningful reduction in heartburn severity. |
| 2019-10-09 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Colesevelam Hydrochloride Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Colesevelam Hydrochloride Tablets, (US RLD - Welchol), 625 mg. |
| 2018-07-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet |
| 2018-06-05 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Pharmaceuticals Presents IW-3718 Data Showing Improvements in Heartburn and Regurgitation Symptoms in Patients with Persistent GERD at Digestive Disease Week® 2018 ironwoodpharma.com ↗
The data demonstrated that, compared to placebo, IW-3718 1500 mg plus a once a day proton pump inhibitor (PPI) improved symptoms of heartburn severity in the overall population of GERD patients in the trial. |
| 2018-05-17 | Impax Laboratories, LLC | Regulatory Amneal Announces FDA Approval and Launch of Generic Welchol® (Colesevelam HCl) Tablets, 625 mg amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol ® (colesevelam HCI) tablets, 625 mg. |
| 2017-08-03 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Pharmaceuticals Provides Second Quarter 2017 Investor Update ironwoodpharma.com ↗
In the study, IW-3718 1500 mg plus a PPI also showed a 55.4% reduction in regurgitation frequency compared to 37.9% in patients treated with a PPI alone. |
| 2017-07-20 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Pharmaceuticals Reports Positive Top-line Results from IW-3718 Phase IIb Trial in Uncontrolled Gastroesophageal Reflux Disease ironwoodpharma.com ↗
The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor (PPI) significantly reduced heartburn severity in patients with uncontrolled GERD compared to patients treated with a PPI alone. |
| 2015-10-19 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Highlights Refractory GERD and Constipation Research at the American College of Gastroenterology 2015 Annual Scientific Meeting ironwoodpharma.com ↗
The oral presentations include data from a Phase IIa study of IW-3718 indicating that this investigational drug improved heartburn and certain other symptoms associated with refractory gastroesophageal reflux disease (GERD). |
| 2015-02-04 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Reports Positive Top-Line Data from Exploratory Phase IIa Trial Of IW-3718 in Refractory Gastroesophageal Reflux Disease ironwoodpharma.com ↗
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that top-line data from an exploratory Phase IIa clinical study indicate IW-3718 improved heartburn and certain other symptoms associated with refractory gastroesophageal reflux disease (GERD). |
| 2010-01-15 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to WELCHOL(R) 625 mg Tablets amneal.com ↗
Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of WELCHOL(R) with the U.S. Food & Drug Administration ("FDA"). |
| 2008-01-21 | Daiichi Sankyo | Regulatory Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes daiichisankyo.com ↗
Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C). |
| 2007-01-05 | Daiichi Sankyo | Regulatory DAIICHI SANKYO, INC. ANNOUNCES FILING OF SUPPLEMENTAL NEW DRUG APPLICATION FOR WELCHOL IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS daiichisankyo.com ↗
Daiichi Sankyo, Inc. announced today that ithas filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for WelChol® (colesevelam HCl) to improve glycemic control in patients with type 2 diabetes mellitus. |
All press releases naming this drug 25 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | colesevelam | “Colesevelam has shown efficacy in adults with type 2 diabetes mellitus (T2DM) in combination with metformin-, sulfonylurea-, or insulin-based therapy, lowering hemoglobin A1c...” PMID 24356792 ↗ Dec 201348“This study tested the LDL cholesterol-lowering agent colesevelam HCl (colesevelam) as a potential novel treatment for improving glycemic control in patients with type 2...” PMID 18458145 ↗ May 2008 “Cholestyramine or Colesevelam lifelong.” NCT04003181 ↗ |
| Known as | cholestagel | “Colesevelam hydrochloride film-coated tablets (Cholestagel)” NCT00692250 ↗ |
| Known as | Colesevelam (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068331 ↗ |
| Known as | colesevelam HCl | “Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of...” NCT00570739 ↗5“This study tested the LDL cholesterol-lowering agent colesevelam HCl (colesevelam) as a potential novel treatment for improving glycemic control in patients with type 2...” PMID 18458145 ↗ May 2008 “3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.” NCT00993824 ↗ “colesevelam HCl tablets and fenofibrate tablets” NCT00754039 ↗ “Drug: Colesevelam HCl” NCT00484419 ↗ |
| Known as | Colesevelam hydrochloride | “Subjects had type 2 diabetes mellitus that was not adequately controlled (glycated hemoglobin level, 7.5%-9.5%, inclusive) receiving insulin therapy alone or in combination...” PMID 18663165 ↗ Jul 20087“Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects.” PMID 18852398 ↗ Oct 2008 “Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes: a randomized, prospective study.” PMID 20634176 ↗ Jul 2010 “Colesevelam hydrochloride film-coated tablets (Cholestagel)” NCT00692250 ↗ |
| Known as | Colesevelam hydrochloride film-coated tablets | “Drug: Colesevelam hydrochloride film-coated tablets” NCT00655265 ↗ |
| Known as | GT-31-104HB | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068331 ↗ |
| Known as | IW-3718 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02030925 ↗ |
| Known as | NSC-760126 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068331 ↗ |
| Known as | Welchol | “Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam...” NCT03270085 ↗3“This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes” NCT00147745 ↗ |
| Known as | WELCHOL (colesevelam hydrochloride) | “WELCHOL (colesevelam hydrochloride)” NCT00938405 ↗ |
| Action | Inhibit | “colesevelam, a medication that inhibits fat absorption” NCT00715273 ↗ |
| Modality | Other / unclassified | “is a non-absorbed polymer” NCT00596427 ↗ |
| Route | Oral | “Colesevelam is an oral, non-absorbable bile-acid sequestrant” NCT00756171 ↗ |