Mesalamine
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LIALDA | — | 2011-07-14 – 2020-06-26 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | CANASA | — | 2004-11-05 – 2016-09-02 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | DELZICOL | — | 2014-04-28 – 2015-09-09 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | ASACOL | — | 1997-08-19 – 2015-05-27 | fda.gov ↗ |
| Approved | US (FDA) | ROWASA | — | 1987-12-24 | fda.gov ↗ |
Trials 88 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT03327558 | May → Jun 2017 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02196662 | Jul 2014 → Apr 2015 | — | Holy Stone Healthcare Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02125292 | Jun 2014 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02306785 | Oct 2012 → Feb 2013 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 1 | NCT02306772 | Dec 2011 → Feb 2012 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 1 | NCT01469637 | Nov → Dec 2011 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01442688 | Oct → Nov 2011 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01418365 | Aug → Oct 2011 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01402947 | Jul → Aug 2011 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT01130844 | Oct 2010 → Jun 2013 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00622375 | Feb 2008 | — | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00751699 | Mar → Apr 2007 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 1 | NCT00254618 | Oct 2005 → Jun 2008 | ulcerative colitis | Warner Chilcott | Terminated | No outcome recorded |
| Phase 1 | NCT00840203 | May → Jun 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00069498 | Oct 1999 → ? | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05091775 | Jun → Aug 2020 | diarrheal disease, ulcer of anus and rectum | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT03399903 | May 2017 → Mar 2019 | HIV infectious disease, colitis | AIDS Healthcare Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT01841099 | Jun 2013 → May 2014 | protein-energy malnutrition | Kelsey Jones | Completed | No outcome recorded |
| Phase 1/2 | NCT01088243 | Mar 2010 → Mar 2015 | chronic beryllium disease | National Jewish Health | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT05663775 | Aug 2024 → Aug 2026 overdue | diarrheal disease, melanoma, rectal carcinoma | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT05488405 | Feb → Jun 2023 | eosinophilic esophagitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 2 | NCT04920149 | Mar 2022 → Sep 2032 expected | Lynch syndrome, colonic neoplasm | Ann-Sofie Backman | Recruiting | No outcome recorded |
| Phase 2 | NCT03070574 | Nov 2017 → Apr 2019 | colorectal cancer | Christoph Gasche | Terminated | No outcome recorded |
| Phase 2 | NCT02493712 | Jan 2016 → Jul 2018 | ulcerative colitis | Holy Stone Healthcare Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01966783 | Sep 2013 → Aug 2015 | proctitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 2 | NCT04032652 | Dec 2012 → Nov 2014 | ulcerative colitis | Endeavor Health | Terminated | No outcome recorded |
| Phase 2 | NCT02077777 | Oct 2012 → Jun 2016 | colorectal cancer | SOFAR S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01894685 | Jul 2012 → Jun 2015 | colorectal adenoma | UMC Utrecht | Completed | No outcome recorded |
| Phase 2 | NCT01699438 | Apr 2012 → Dec 2016 | irritable bowel syndrome | Hans Törnblom | Completed | No outcome recorded |
| Phase 2 | NCT01177410 | Jul 2010 → Aug 2011 | irritable bowel syndrome | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00514982 | Aug 2007 → Mar 2011 | Hermansky-Pudlak syndrome, colitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 2 | NCT00545389 | Feb 2003 → Oct 2004 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01627262 | May 2002 → Aug 2004 | large intestine disorder | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02044952 | Jan 2014 → May 2016 | Crohn disease | Zhu Weiming | Unknown | No outcome recorded |
| Phase 2/3 | NCT00952952 | Feb → Nov 2007 | diarrheal disease, microscopic colitis | Mayo Clinic | Completed | No outcome recorded |
| Phase 339 trials | ||||||
| Phase 3 | NCT05316220 | Sep 2025 → Jul 2026 | ulcerative colitis | AbbVie | Withdrawn | No outcome recorded |
| Phase 3 | NCT06176560 | Mar 2024 → Aug 2025 | ulcerative colitis | Faes Farma, S.A. | Unknown | No outcome recorded |
| Phase 3 | NCT02665845 | Jun 2016 → May 2021 | ulcerative colitis | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 3 | NCT02769494 | Mar → Dec 2016 | Crohn disease, ulcerative stomatitis | Xijing Hospital of Digestive Diseases | Withdrawn | No outcome recorded |
| Phase 3 | NCT02522780 | Feb 2016 → Sep 2018 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02522767 | Oct 2015 → Feb 2018 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02368717 | Mar 2015 → Jan 2017 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02093663 | Dec 2014 → Nov 2018 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01745770 | Jan 2013 → Mar 2015 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01257399 | Nov 2010 → Jan 2013 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 3 | NCT01172444 | Jun 2010 → Dec 2012 | proctitis | Sandoz | Terminated | No outcome recorded |
| Phase 3 | NCT01412372 | Jun 2010 → Apr 2019 | irritable bowel syndrome | University of Utah | Completed | No outcome recorded |
| Phase 3 | NCT01209208 | May 2010 → Jun 2017 | lymphocytic colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01038739 | Jan 2010 → Jan 2013 | diverticulitis | Dr. Falk Pharma GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT01016262 | Nov 2009 → Jul 2011 | proctitis | Forest Laboratories | Terminated | No outcome recorded |
| Phase 3 | NCT01059344 | Nov 2009 → Jul 2011 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 3 | NCT01004185 | Oct 2009 → Mar 2011 | ulcerative colitis | Warner Chilcott | Terminated | No outcome recorded |
| Phase 3 | NCT00862121 | Apr 2009 → Oct 2010 | Crohn disease | Ferring Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00245505 | Feb → Jun 2009 | Crohn disease | Ferring Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00713310 | Dec 2008 → Mar 2011 | ulcerative colitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00737789 | Nov 2008 → Jun 2010 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00695643 | Jan 2008 → Nov 2011 | diverticulitis | Dr. Falk Pharma GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT00545103 | Dec 2007 → Nov 2011 | diverticulitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00626288 | Dec 2007 → Mar 2012 | irritable bowel syndrome | SOFAR S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00545740 | Nov 2007 → Mar 2012 | diverticulitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00450086 | Mar 2007 → Jun 2011 | collagenous colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00708656 | Oct 2006 → Jul 2010 | ulcerative colitis | Cardiff and Vale University Health Board | Completed | No outcome recorded |
| Phase 3 | NCT00343850 | Sep 2006 → Mar 2007 | ulcerative colitis | University of Chicago | Completed | No outcome recorded |
| Phase 3 | NCT00350415 | Jun 2006 → May 2007 | ulcerative colitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00326209 | Dec 2005 → May 2008 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00449722 | Jul 2005 → Jun 2006 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00209300 | May 2005 → May 2007 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00151892 | Apr 2005 → Sep 2009 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00092508 | May 2004 → May 2007 | ulcerative colitis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00548574 | Dec 2003 → Oct 2004 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00151944 | Nov 2003 → Mar 2006 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00503243 | Sep 2003 → Jan 2005 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00577473 | Feb 2001 → Feb 2003 | ulcerative colitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00073021 | Sep 2000 → Sep 2003 | ulcerative colitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07248644 | May → Sep 2026 expected | ulcerative colitis | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05205603 | Jan 2022 → Jan 2024 | ulcerative colitis | Sixth Affiliated Hospital, Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT02190526 | Sep 2014 → Dec 2015 | irritable bowel syndrome | Tehran University of Medical Sciences | Withdrawn | No outcome recorded |
| Phase 4 | NCT01536535 | Jul 2012 → Apr 2018 | ulcerative colitis | Connecticut Children's Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01316718 | Mar 2011 → Sep 2013 | irritable bowel syndrome | University of Nottingham | Completed | No outcome recorded |
| Phase 4 | NCT01201122 | Sep 2010 → Dec 2015 | ulcerative colitis | Wolfson Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01124149 | Jun 2010 → Dec 2012 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase 4 | NCT01090102 | Jun 2010 → Dec 2012 | AIDS | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01789294 | Nov 2008 → Feb 2013 | — | Azienda Policlinico Umberto I | Unknown | No outcome recorded |
| Phase 4 | NCT00652145 | Sep 2008 → Jan 2013 | ulcerative colitis | James Lewis | Completed | No outcome recorded |
| Phase 4 | NCT00446849 | May 2007 → Aug 2009 | ulcerative colitis | Shire | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT03917095 | May → Jun 2019 | ulcerative colitis | The Second Hospital of Nanjing Medical University | Unknown | No outcome recorded |
| — | NCT01999400 | Apr 2012 → Sep 2015 | — | University of Michigan | Completed | No outcome recorded |
| — | NCT00349388 | Jul 2006 → Jan 2011 | ulcerative colitis | Annette Langseder | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 62 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06525974 Comparator | Sep 2024 → Sep 2026 expected | ulcerative colitis | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05912712 Comparator | Jul 2023 → Jun 2025 | solitary rectal ulcer syndrome, ulcerative colitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 1 | NCT01020708 Comparator | Nov 2009 → Sep 2010 | ulcerative colitis | Altheus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05119140 Background | Jun 2022 → May 2025 overdue | ulcerative colitis | Icahn School of Medicine at Mount Sinai | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03441893 Comparator | Jan 2015 → Jul 2025 | helminthiasis, protozoa infectious disease, ulcerative colitis | Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan | Unknown | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07333716 Comparator | Jan 2026 → Feb 2027 expected | ulcerative colitis | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT07349472 Comparator | Jan 2026 → Jan 2027 expected | inflammatory bowel disease | Ihab Elsayed Hassan | Recruiting | No outcome recorded |
| Phase 2 | NCT07064707 Comparator | Jul 2025 → Jul 2026 overdue | ulcerative colitis | Alexandria University | Recruiting | No outcome recorded |
| Phase 2 | NCT06993974 Comparator | May 2025 → Aug 2026 overdue | ulcerative colitis | Alexandria University | Recruiting | No outcome recorded |
| Phase 2 | NCT06213857 Background | Feb → May 2025 overdue | ulcerative colitis | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT06201793 Comparator | Jan 2024 → Jan 2025 | inflammatory bowel disease | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2 | NCT05781698 Comparator | Mar 2023 → Oct 2024 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT05567068 Background | Feb 2023 → Jun 2025 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT03104036 Comparator | Jun 2017 → Jan 2021 | ulcerative colitis | Institute for Clinical and Experimental Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02335281 Comparator | Jan 2015 → Oct 2017 | Crohn disease, ulcerative colitis | Yanling Wei | Unknown | No outcome recorded |
| Phase 2 | NCT01586533 Comparator | Jun 2012 → Apr 2014 | ulcerative colitis | Altheus Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01327300 Comparator | Mar 2010 → Mar 2012 | irritable bowel syndrome | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT00808977 Comparator | Dec 2008 → Jun 2010 | ulcerative colitis | Palau Pharma S.L.U. | Completed | No outcome recorded |
| Phase 2 | NCT00554099 Comparator | Nov 2007 → Mar 2010 | diverticulitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT05988528 Comparator | Aug 2023 → Feb 2025 | inflammatory bowel disease | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2/3 | NCT05986136 Comparator | Aug 2023 → Aug 2027 expected | inflammatory bowel disease | Mostafa Bahaa | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05753267 Comparator | Feb 2023 → Sep 2025 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2/3 | NCT03804931 Background | Jan 2019 → Dec 2028 expected | ulcerative colitis | Guangzhou First People's Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00774007 Comparator | Sep 2004 → Nov 2005 | irritable bowel syndrome | SOFAR S.p.A. | Completed | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT03716388 Comparator | Dec 2018 → Dec 2019 | ulcerative colitis | Dayanand Medical College and Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03412682 Comparator | Mar 2018 → May 2020 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02910245 Comparator | Nov 2016 → Apr 2022 | ulcerative colitis | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 3 | NCT02683733 Comparator | Feb 2016 → Feb 2017 | ulcerative colitis | Asian Institute of Gastroenterology, India | Unknown | No outcome recorded |
| Phase 3 | NCT02280629 Comparator | Oct 2014 → Oct 2018 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01514240 Comparator | Feb 2012 → Sep 2014 | Crohn disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01532648 Background | Jan 2012 → Oct 2013 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01320436 Comparator | Jul 2011 → Sep 2014 | ulcerative colitis | Sheba Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01257386 Comparator | Nov 2010 → Aug 2012 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 3 | NCT00984568 Comparator | Nov 2009 → Mar 2012 | ulcerative colitis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT00679432 Comparator | Jun 2008 → May 2010 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01045018 Comparator | Jan 2008 → Jun 2009 | ulcerative colitis | EMET Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00747110 Comparator | Oct 2007 → Aug 2008 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00603733 Comparator | Oct 2007 → May 2011 | ulcerative colitis | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00505778 Comparator | Jul 2007 → Jul 2009 | ulcerative colitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT01120340 Comparator | Oct 2005 → Nov 2011 | diverticulitis | SOFAR S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00746447 Comparator | May 2005 → Apr 2007 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00767728 Comparator | Dec 2004 → Aug 2007 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00744016 Comparator | Dec 2004 → May 2007 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00300118 Comparator | Sep 2004 → May 2008 | Crohn disease | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00976690 Comparator | Oct 2002 → Oct 2010 | Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Completed | No outcome recorded |
| Phase 3 | NCT00946946 Comparator | Feb 2002 → May 2007 | Crohn disease | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07546097 Comparator | Mar 2026 → Mar 2027 expected | ulcerative colitis | Yongquan Shi | Recruiting | No outcome recorded |
| Phase 4 | NCT06625450 Comparator | Oct 2024 → Dec 2025 overdue | ulcerative colitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04133194 Comparator | Nov 2019 → Dec 2024 | ulcerative colitis | Flemming Bendtsen | Unknown | No outcome recorded |
| Phase 4 | NCT03110198 Comparator | May 2017 → Jan 2018 | ulcerative colitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 4 | NCT01941589 Comparator | Sep 2013 → Apr 2021 | ulcerative colitis | Sheba Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01696942 Comparator | Feb 2013 → Jun 2016 | Crohn disease | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01534754 Comparator | Jan 2009 → Oct 2011 | colonic disorder | Hospital Cristo Re | Completed | No outcome recorded |
| Phase 4 | NCT00194818 Comparator | Jun 2003 → Aug 2007 | ulcerative colitis | University of Washington | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07389824 Background | Feb 2026 → Sep 2027 expected | ulcerative colitis | Qin Yu | Not yet recruiting | No outcome recorded |
| — | NCT06067698 Comparator | Oct 2023 → Apr 2025 overdue | ulcerative colitis | Tanta University | Recruiting | No outcome recorded |
| — | NCT05780723 Comparator | Apr 2023 → Oct 2024 | ulcerative colitis | Beijing Hospital of Traditional Chinese Medicine | Completed | No outcome recorded |
| — | NCT05538026 Comparator | Sep 2020 → Jan 2022 | ulcerative colitis | Bogomolets National Medical University | Completed | No outcome recorded |
| — | NCT03415711 Background | Apr 2017 → Apr 2019 | ulcerative colitis | VSL Pharmaceuticals | Terminated | No outcome recorded |
| — | NCT02537210 Comparator | Sep 2015 → Sep 2021 | ulcerative colitis | Chinese University of Hong Kong | Completed | No outcome recorded |
| — | NCT01534312 Comparator | Jan 2012 → Sep 2014 | ulcerative colitis | University of Aarhus | Completed | No outcome recorded |
| — | NCT00802451 Comparator | Feb → Mar 2003 | — | Padagis LLC | Completed | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-04-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of its Generic Version of Canasa® (mesalamine) Suppositories To Treat Adults with Active Ulcerative Proctitis (ulcerative rectal colitis), in the United States tevapharm.com ↗ |
| 2019-05-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces the Launch of a Generic Version of Delzicol® (mesalamine) Delayed-Release Capsules in the United States tevapharm.com ↗ |
| 2018-03-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces the Launch of a Generic Version of Lialda® in the United States tevapharm.com ↗ |
| 2016-10-05 | Takeda | Patent Trial and Appeal Board Upholds the Validity of LIALDA® Patent takeda.com ↗ |
| 2016-09-16 | Takeda | District Court Issues Ruling in Hatch Waxman Case Regarding Shire’s LIALDA® takeda.com ↗ |
| 2016-03-29 | Takeda | Shire Wins Patent Trial against Watson Concerning LIALDA® takeda.com ↗ |
| 2015-04-06 | Takeda | Shire Comments on USPTO Petitions Related to LIALDA and GATTEX takeda.com ↗ |
| 2013-05-09 | Takeda | Shire Wins Patent Trial Against Watson Concerning LIALDA® takeda.com ↗ |
| 2004-10-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Mesalamine Rectal Suspension Usp tevapharm.com ↗ |
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 166 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mesalamine | “SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a...” PMID 17241860 ↗ Oct 200683“The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule...” NCT03327558 ↗ “After the screening visits, eligible patients will be randomized to 1 of 3 study groups: (1) IBD98 M 0.8 g/day (mesalamine 0.8 g with sodium hyaluronate 92 mg), (2) IBD98 M 1.2...” NCT02493712 ↗ “A randomised, open-label, parallel-group study of mesalamine pharmacokinetics following Lialda 2 × 1.2 g once daily (QD) (dose A), Asacol 6 × 400 mg QD (dose B), or Asacol 2 ×...” PMID 32671846 ↗ Aug 2020 “compare the rate and extent of absorption of mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus Delzicol 400 mg delayed-release...” NCT02196662 ↗ “Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission.” PMID 35272029 ↗ Mar 2022 “MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.” NCT01442688 ↗ “Patients were randomly assigned to groups that were given budesonide MMX (9 mg or 6 mg), mesalamine (2.4 g, as reference), or placebo for 8 weeks.” PMID 22892337 ↗ Aug 2012 “Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC” NCT02665845 ↗ “Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis.” PMID 17234558 ↗ Jan 2007 “This study evaluated the pharmacokinetics of mesalamine and its major metabolite of mesalamine known as N-acetyl-mesalamine in plasma.” NCT01999400 ↗ “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06201793 ↗ “Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)” NCT01532648 ↗ “Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet)” NCT00350415 ↗ “new mesalamine suppositories (MAX-002) as compared to placebo and active medicine” NCT01016262 ↗ “PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.” NCT00862121 ↗ “mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine” NCT01004185 ↗ “standardised mesalazine (mesalamine) therapy” PMID 31373712 ↗ Aug 2019 “Mesalazine (Mesalamine)” NCT00245505 ↗ |
| Known as | 5- amino salicylic acid | “Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC...” NCT07064707 ↗13“Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of...” PMID 41213710 ↗ Nov 2025 “Despite mesalamine's or 5-amino salicylic acid's (5-ASA) established role in inducing and maintaining remission, some patients experience persistent symptoms and inflammatory activity.” PMID 41235106 ↗ Oct 2025 “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06201793 ↗ “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06525974 ↗ “Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT05753267 ↗ “Limited data are available on mesalamine (5-aminosalicylic acid; 5-ASA) use in pediatric ulcerative colitis (UC).” PMID 26893546 ↗ Feb 2016 “Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC).” NCT06993974 ↗ “Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis.” NCT05986136 ↗ “Mesalamine (5-aminosalicylic acid, Apriso)” NCT01090102 ↗ |
| Known as | 5-aminosalicylic acid (5-ASA) | “Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis.” NCT05988528 ↗1“Mesalamine, also known as 5-aminosalicylic acid (5-ASA)” NCT05663775 ↗ |
| Known as | 5-ASA | “Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC...” NCT07064707 ↗11“Despite mesalamine's or 5-amino salicylic acid's (5-ASA) established role in inducing and maintaining remission, some patients experience persistent symptoms and inflammatory activity.” PMID 41235106 ↗ Oct 2025 “Mesalamine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT05753267 ↗ “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06525974 ↗ “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06201793 ↗ “Limited data are available on mesalamine (5-aminosalicylic acid; 5-ASA) use in pediatric ulcerative colitis (UC).” PMID 26893546 ↗ Feb 2016 “Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC).” NCT06993974 ↗ “Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis.” NCT05986136 ↗ “the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa” NCT00069498 ↗ “Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)” NCT01586533 ↗ “5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine” NCT01320436 ↗ “Several oral mesalazine (5-ASA) formulations exist” NCT04133194 ↗ |
| Known as | 5-ASA (5-Aminosalicylate) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00603733 ↗ |
| Known as | Apriso | “Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover phase” NCT01999400 ↗1“Mesalamine (5-aminosalicylic acid, Apriso)” NCT01090102 ↗ |
| Known as | Asacol | “This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for...” PMID 20064514 ↗ Jan 201013“Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum.” NCT04032652 ↗ “To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine” NCT01257386 ↗ “Patients received mesalazine (mesalamine) 4.8 g/day (Asacol 800 mg MR) or 2.4 g/day (Asacol 400 mg MR).” PMID 21385195 ↗ Mar 2011 “Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)” NCT01532648 ↗ “Asacol® 2.4 g/Day (400 mg Mesalamine Tablet)” NCT00554099 ↗ “1600 mg Asacol [mesalazine]” NCT04133194 ↗ “Asacol 800 mg (mesalamine)” NCT00073021 ↗ “mesalazine (Asacol®)” NCT00708656 ↗ “Asacol (mesalamine)” NCT00343850 ↗ |
| Known as | Asacol HD | “Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)” NCT01532648 ↗ |
| Known as | Canasa | “Canasa® Rectal Suppositories (1000 mg Mesalamine, USP)” NCT01172444 ↗ |
| Known as | Delzicol | “compare the rate and extent of absorption of mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus Delzicol 400 mg delayed-release...” NCT02196662 ↗1“Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose” NCT01999400 ↗ |
| Known as | eMG | “To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment...” NCT00767728 ↗1“encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP])” NCT00326209 ↗ |
| Known as | IBD98-M | “compare the rate and extent of absorption of mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus Delzicol 400 mg delayed-release...” NCT02196662 ↗ |
| Known as | IBD98-M without HA | “IBD98-M without HA: Mesalamine 200mg X2” NCT02196662 ↗ |
| Known as | Lialda | “Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover phase” NCT01999400 ↗1“Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)” NCT01532648 ↗ |
| Known as | MAX-002 | “new mesalamine suppositories (MAX-002) as compared to placebo and active medicine” NCT01016262 ↗ |
| Known as | MES | “1 g mesalamine suppositories (1 g MES;” PMID 29702300 ↗ Apr 2018 |
| Known as | Mesalamin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01059344 ↗ |
| Known as | Mesalazine | “A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Ciprofloxacin XR Administered Alone and in Combination With MMX®...” NCT01402947 ↗68“An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release...” NCT02306772 ↗ “Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two double-blind placebo-controlled trials.” PMID 22617015 ↗ May 2012 “Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study.” PMID 26905266 ↗ Feb 2016 “Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis.” NCT00151892 ↗ “Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).” NCT01469637 ↗ “Asacol is a delayed-release tablet formulation designed to deliver mesalamine (also known as mesalazine) at a pH ≥ 7.0.” NCT00254618 ↗ “Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management.” NCT06525974 ↗ “Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum.” NCT04032652 ↗ “Patients received mesalazine (mesalamine) 4.8 g/day (Asacol 800 mg MR) or 2.4 g/day (Asacol 400 mg MR).” PMID 21385195 ↗ Mar 2011 “replacing thiopurines with high-dose oral mesalazine (≥ 3 g/day) may preserve remission” NCT07248644 ↗ “Mesalazine is used to treat and prevent mild to moderate acute fissure disease” NCT05091775 ↗ “Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine” NCT01418365 ↗ “PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.” NCT00862121 ↗ “using scintigraphic images and mesalazine plasma levels (PK)” NCT02306785 ↗ “with mesalazine 4 g/day as maintenance therapy.” NCT07546097 ↗ “4800 grams/day of Mesalazine (Asacol/Mezavant)” NCT01534312 ↗ “MMX Mesalamine/Mesalazine (Low Dose)” NCT02093663 ↗ “Mesalazine and/or Prednisone” NCT03804931 ↗ “MMX mesalamine/ mesalazine” NCT01124149 ↗ |
| Known as | Mesalazine, Pentasa (trade name) | “Mesalazine, Pentasa (trade name)” NCT01841099 ↗ |
| Known as | mesalzine | “Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC” NCT02665845 ↗ |
| Known as | Mesavancol | “Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).” NCT01469637 ↗ |
| Known as | MEZAVANT | “SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a...” PMID 17241860 ↗ Oct 20061“Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).” NCT01469637 ↗ |
| Known as | MMX Mesalamine | “SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a...” PMID 17241860 ↗ Oct 20063“MMX® mesalamine is a once daily oral 5-aminosalicylic acid formulation, effective in induction and maintenance of ulcerative colitis remission.” PMID 24868146 ↗ May 2014 “Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis.” PMID 17234558 ↗ Jan 2007 “30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.” NCT01130844 ↗ |
| Known as | MMX mesalazine | “AIM: Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2...” PMID 18272546 ↗ Feb 20083“SPD476 (MMX mesalazine), is a novel, once daily, high-strength mesalazine formulation (1.2 g/tablet) that utilizes Multi Matrix System (MMX) technology to delay and extend...” PMID 16984503 ↗ Oct 2006 “Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine” NCT01418365 ↗ “SPD476, MMX™ mesalazine, 1.2g extended release tablet” NCT00545103 ↗ |
| Known as | MMX Mesalazine/mesalamine | “Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).” NCT01469637 ↗ |
| Known as | multimatrix mesalamine | “AIM: To evaluate pharmacokinetic and safety profiles of 5-ASA and metabolite acetyl-5-ASA (Ac-5-ASA) after once-daily, oral administration of multimatrix mesalamine to children...” PMID 26893546 ↗ Feb 2016 |
| Known as | Pentasa | “Indeed, two recent studies among adults with UC suggest that once daily dosing of mesalamine (Pentasa® and Salofalk®) may be as or more effective than twice daily dosing.” NCT01201122 ↗8“Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover phase” NCT01999400 ↗ “Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)” NCT01532648 ↗ “Pentasa (mesalazine) sachets 2 g morning + 2 g evening during 12 weeks treatment” NCT00245505 ↗ “Mesalazine (Pentasa) comes in 500mg capsules” NCT01536535 ↗ “Pentasa, SHP429” NCT02125292 ↗ |
| Known as | Salofalk | “OBJECTIVES: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine)...” PMID 18832520 ↗ Oct 20081“Indeed, two recent studies among adults with UC suggest that once daily dosing of mesalamine (Pentasa® and Salofalk®) may be as or more effective than twice daily dosing.” NCT01201122 ↗ |
| Known as | SHP429 | “Pentasa, SHP429” NCT02125292 ↗ |
| Known as | SPD476 | “SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a...” PMID 17241860 ↗ Oct 20066“A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With...” NCT00151892 ↗ “SPD476 (MMX mesalazine), is a novel, once daily, high-strength mesalazine formulation (1.2 g/tablet) that utilizes Multi Matrix System (MMX) technology to delay and extend...” PMID 16984503 ↗ Oct 2006 “Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis.” PMID 17234558 ↗ Jan 2007 “SPD476, MMX™ mesalazine, 1.2g extended release tablet” NCT00545103 ↗ “SPD476 (mesalazine)” NCT00151944 ↗ |
| Action | Inhibit | “mesalazine inhibits Wnt/beta-catenin signalling” NCT01894685 ↗ |
| Modality | Small molecule | “long-term 5-aminosalicylic acid therapy” PMID 21837775 ↗ Aug 2011 |
| Route | Oral | “delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day” PMID 21255059 ↗ Jan 2011 |