Mesalamine

also known as Mesalazine · Asacol · 5-aminosalicylic acid · 5-ASA · Pentasa · SPD476 · MMX mesalamine · MMX mesalazine · +19 more

Small molecule

Developed for: ulcerative colitis · irritable bowel syndrome · Crohn disease · diarrheal disease · diverticulitis · proctitis · colitis · colorectal cancer
+15 more
· chronic beryllium disease · collagenous colitis · colonic neoplasm · colorectal adenoma · eosinophilic esophagitis · HIV infectious disease · large intestine disorder · lymphocytic colitis · Lynch syndrome · microscopic colitis · protein-energy malnutrition · ulcer of anus and rectum · ulcerative stomatitis · colonic disorder · solitary rectal ulcer syndrome
Investigated by: Shire · Dr. Falk Pharma GmbH · Ferring Pharmaceuticals · Warner Chilcott · Bausch Health Americas, Inc. · Tillotts Pharma AG
+68 more
· Procter and Gamble · Holy Stone Healthcare Co., Ltd · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · SOFAR S.p.A. · AHS Cancer Control Alberta · AIDS Healthcare Foundation · AbbVie · Alimenta AB · Ann-Sofie Backman · Ann-Sofie Backman, MD PhD, Sweden · Annette Langseder · Azienda Policlinico Umberto I · California HIV/AIDS Research Program · Cardiff and Vale University Health Board · Christoph Gasche · Connecticut Children's Medical Center · Edward V. Loftus MD · Endeavor Health · Faes Farma, S.A. · Food and Drug Administration (FDA) · Forest Laboratories · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · HIV Immunotherapeutics Institute · Hans Törnblom · Haukeland University Hospital · Imperial College London · Innlandet Hospital Trust · James Lewis · Karolinska Institutet · Karolinska University Hospital · Kelsey Jones · Mayo Clinic · National Institute for Health Research, United Kingdom · National Institute of Allergy and Infectious Diseases (NIAID) · National Jewish Health · Oslo University Hospital · Otsuka Pharmaceutical Development & Commercialization, Inc. · Paul E. Evans MD · Prof. Dr. Gabriela Möslein, Germany · Prof. Dr. Hans Vasen, The Netherlands · Prof. Dr. med. Jan Lubinski, Poland · Prof. Dr. med. Yaron Niv, Israel · Sahlgrenska University Hospital · Sandoz · Shiraz University of Medical Sciences · Shire Human Genetic Therapies, Inc. · Sixth Affiliated Hospital, Sun Yat-sen University · Smerud Medical Research International AS · Tehran University of Medical Sciences · Teva Pharmaceuticals USA · The Second Hospital of Nanjing Medical University · The Swedish Research Council · Thomas C. Smryk MD · UMC Utrecht · Univ. Prof. Dr. Judith Karner-Hanusch, Austria · University Hospital of Saint-Etienne · University of California, San Francisco · University of Chicago · University of Michigan · University of Nottingham · University of Utah · Willaim Tremaine MD · William J. Sandborn MD · Wolfson Medical Center · Xijing Hospital of Digestive Diseases · Zeria Pharmaceutical · Zhu Weiming · inVentiv Health Clinical

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 85 · started per year

today

US approved 1987

198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 114 trials · 4 met primary
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	Met primary
Phase 1	NCT01442688	Oct → Nov 2011	—	Shire	Completed	Met primary
Phase 1	NCT01418365	Aug → Oct 2011	—	Shire	Completed	Met primary
Phase 1	NCT01402947	Jul → Aug 2011	—	Shire	Completed	Met primary
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 Stop: Enrollment
Phase 1	NCT00840203	May → Jun 2003	—	Teva Pharmaceuticals USA	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 · 1 met primary · 2 missed
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 Stop: Enrollment
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 Stop: Enrollment
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	Met primary
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	Missed primary
Phase 2	NCT01627262	May 2002 → Aug 2004	large intestine disorder	Dr. Falk Pharma GmbH	Completed	Missed primary

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 337 trials · 8 met primary · 11 missed
Phase 3	NCT05316220	Sep 2025 → Jul 2026	ulcerative colitis	AbbVie	Withdrawn	No outcome recorded Stop: Business
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 Stop: Business
Phase 3	NCT02522780	Feb 2016 → Sep 2018	ulcerative colitis	Ferring Pharmaceuticals	Completed	Missed primary
Phase 3	NCT02522767	Oct 2015 → Feb 2018	ulcerative colitis	Ferring Pharmaceuticals	Completed	Missed primary
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	Mixed
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	Met primary
Phase 3	NCT01172444	Jun 2010 → Dec 2012	proctitis	Sandoz	Terminated	No outcome recorded Stop: Enrollment
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	Mixed
Phase 3	NCT01038739	Jan 2010 → Jan 2013	diverticulitis	Dr. Falk Pharma GmbH	Terminated	Missed primary
Phase 3	NCT01016262	Nov 2009 → Jul 2011	proctitis	Forest Laboratories	Terminated	Met primary Stop: Business
Phase 3	NCT01004185	Oct 2009 → Mar 2011	ulcerative colitis	Warner Chilcott	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00862121	Apr 2009 → Oct 2010	Crohn disease	Ferring Pharmaceuticals	Terminated	Missed primary Stop: Enrollment
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	Missed primary
Phase 3	NCT00737789	Nov 2008 → Jun 2010	ulcerative colitis	Ferring Pharmaceuticals	Completed	Met primary
Phase 3	NCT00695643	Jan 2008 → Nov 2011	diverticulitis	Dr. Falk Pharma GmbH	Terminated	Missed primary
Phase 3	NCT00545103	Dec 2007 → Nov 2011	diverticulitis	Shire	Completed	Missed primary
Phase 3	NCT00626288	Dec 2007 → Mar 2012	irritable bowel syndrome	SOFAR S.p.A.	Completed	Missed primary
Phase 3	NCT00450086	Mar 2007 → Jun 2011	collagenous colitis	Dr. Falk Pharma GmbH	Completed	Missed primary
Phase 3	NCT00708656	Oct 2006 → Jul 2010	ulcerative colitis	Cardiff and Vale University Health Board	Completed	Met primary
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	Met primary
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	Missed primary
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	Met primary
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	Met primary
Phase 3	NCT00577473	Feb 2001 → Feb 2003	ulcerative colitis	Warner Chilcott	Completed	Missed primary
Phase 3	NCT00073021	Sep 2000 → Sep 2003	ulcerative colitis	Warner Chilcott	Completed	Met primary

Phase 411 trials · 2 met primary · 2 missed
Phase 4	NCT07248644	May → Sep 2026 overdue	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	Missed primary
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	Met primary
Phase 4	NCT01090102	Jun 2010 → Dec 2012	AIDS	University of California, San Francisco	Completed	Missed primary
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	Met primary
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 Stop: Enrollment
Comparator or background therapy58 trials
Phase 0	NCT06525974 Comparator	Sep 2024 → Sep 2026 overdue	ulcerative colitis	Tanta University	Not yet recruiting	No outcome recorded
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 1/2	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 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 2/3	NCT05988528 Comparator	Aug 2023 → Feb 2025	inflammatory bowel disease	Mostafa Bahaa	Completed	No outcome recorded
Phase 2/3	NCT05986136 Comparator	Aug 2023 → Aug 2026	inflammatory bowel disease	Mostafa Bahaa	Completed	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 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	NCT02280629 Comparator	Oct 2014 → Oct 2018	ulcerative colitis	Dr. Falk Pharma GmbH	Completed	Missed primary
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	NCT01257386 Comparator	Nov 2010 → Aug 2012	ulcerative colitis	Tillotts Pharma AG	Completed	No outcome recorded
Phase 3	NCT00679432 Comparator	Jun 2008 → May 2010	ulcerative colitis	Bausch Health Americas, Inc.	Completed	Met primary
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	Missed primary
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	NCT00744016 Comparator	Dec 2004 → May 2007	ulcerative colitis	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 3	NCT00767728 Comparator	Dec 2004 → Aug 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	Met primary
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	Missed primary
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 Stop: Enrollment
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
—	NCT07389824 Background	Feb 2026 → Sep 2027 expected	ulcerative colitis	Qin Yu	Not yet recruiting	No outcome recorded
—	NCT06067698 Comparator	Oct 2023 → Apr 2025	ulcerative colitis	Tanta University	Completed	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	Missed primary
—	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

News releases announcing trial results or a regulatory action · 11

Date	Issuer	Release
2024-10-01	Ferring Pharmaceuticals	Results Ferring demonstrates effectiveness of a treat-to-target approach in mild-to-moderate ulcerative colitis in first major study ferring.com ↗ These data support clinical thinking that T2T is the preferred management strategy for IBD 2,3 and demonstrates that mesalazine therapy is an integral part of this approach in M2M UC.
2022-11-01	Alembic Pharmaceuticals Ltd.	Regulatory 2nd November, 2022, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.
2022-05-12	Sun Pharmaceutical Industries, Inc.	Regulatory Sun Pharma Announces US FDA Approval for Generic Mesalamine Extended Release Capsules sunpharma.com ↗ today announced that it has received fi nal approval from US FD A for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg.
2021-08-13	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives final approval from USFDA for Mesalamine Extended-Release Capsules zyduslife.com ↗ Zydus Cadila has received final approval from the USFDA to market Mesalamine Extended-Release Capsules in the strength of 0.375 g, (US RLD: Apriso).
2020-06-04	Tillotts Pharma AG	Regulatory Tillotts and Menarini Receive Regulatory Approval for Asacol® 400 and 800 mg Tablets in the People’s Republic of China tillotts.com ↗ Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, and A. Menarini International Trading (Wuhan) Co. Ltd. (“Menarini”), a member of the Italian A. Menarini Group, are pleased to announce the regulatory approval for Asacol ® 400 and 800 mg tablets in the People’s Republic of China (“China”).
2020-02-13	Zydus Lifesciences Limited	Regulatory Zydus receives final approval from the USFDA for Mesalamine Suppositories for rectal use, 1000 mg zyduslife.com ↗ Zydus Cadila has received the final approval from the USFDA to market Mesalamine Suppositories for rectal use, (US RLD - Canasa) 1000 mg.
2017-10-11	Tillotts Pharma AG	Results Tillotts Pharma: Positive Results of Largest Phase III Clinical Trial of Mesalazine Induction Therapy Published tillotts.com ↗ Full results show that the primary objective of the study was met.
2017-05-27	Zydus Lifesciences Limited	Regulatory Zydus Cadila gets USFDA final approval for Mesalamine Delayed-Release Tablets USP, 1.2 g zyduslife.com ↗ Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market.
2017-05-18	Zeria Pharmaceutical	Regulatory 潰瘍性大腸炎治療剤「アサコール錠400mg」新用法・用量の承認取得に関するお知らせ（PDF ファイル 0.12MB） zeria.co.jp ↗
2009-10-16	Zeria Pharmaceutical	Regulatory 潰瘍性大腸炎治療剤「アサコール錠400mg」の製造販売承認取得のお知らせ（PDF ファイル 0.14MB） zeria.co.jp ↗
2004-10-01	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Approval Of Mesalamine Rectal Suspension Usp tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the company's ANDA for Mesalamine Rectal Suspension, USP, 4 gm/60 mL.

All press releases naming this drug 33 releases

Date	Issuer	Release
2025-02-19	Impax Laboratories, LLC	Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide amneal.com ↗
2024-11-27	Tillotts Pharma AG	Tillotts Pharma partners with Pioneer for the marketing and distribution of Tillotts` product Asacol® in the People’s Republic of China tillotts.com ↗
2024-10-01	Ferring Pharmaceuticals	Ferring demonstrates effectiveness of a treat-to-target approach in mild-to-moderate ulcerative colitis in first major study ferring.com ↗
2023-08-21	Upsher-Smith Laboratories	Upsher-Smith Expands Generics Portfolio with Launch of Mesalamine Extended-Release Capsules, USP upsher-smith.com ↗
2022-11-01	Alembic Pharmaceuticals Ltd.	2nd November, 2022, Vadodara, India alembicpharmaceuticals.com ↗
2022-05-12	Sun Pharmaceutical Industries, Inc.	Sun Pharma Announces US FDA Approval for Generic Mesalamine Extended Release Capsules sunpharma.com ↗
2021-08-13	Zydus Lifesciences Limited	Zydus Cadila receives final approval from USFDA for Mesalamine Extended-Release Capsules zyduslife.com ↗
2021-07-28	Tillotts Pharma AG	Tillotts Pharma AG announces launch of Asacol® 800mg Tablets in the People’s Republic of China tillotts.com ↗
2021-05-17	Tillotts Pharma AG	Tillotts Pharma AG announces launch of Asacol TM 1G suppositories for treatment of ulcerative proctitis tillotts.com ↗
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 ↗
2020-06-04	Tillotts Pharma AG	Tillotts and Menarini Receive Regulatory Approval for Asacol® 400 and 800 mg Tablets in the People’s Republic of China tillotts.com ↗
2020-05-19	Lupin Limited	Lupin Launches Authorized Generic Version of Apriso® lupin.com ↗
2020-02-13	Zydus Lifesciences Limited	Zydus receives final approval from the USFDA for Mesalamine Suppositories for rectal use, 1000 mg zyduslife.com ↗
2020-02-03	Kyowa Kirin, Inc.	Kyowa Kirin Announces Termination of Agreement with Zeria Pharmaceutical on ASACOL® kyowakirin.com ↗
2019-10-28	Tillotts Pharma AG	Tillotts partners Menarini to extend Asacol® to the People’s Republic of China tillotts.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 ↗
2019-01-22	Tillotts Pharma AG	Tillotts Pharma AG announces launch of ASACOL TM 1600 mg (mesalazine)* for ulcerative colitis tillotts.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 ↗
2017-10-11	Tillotts Pharma AG	Tillotts Pharma: Positive Results of Largest Phase III Clinical Trial of Mesalazine Induction Therapy Published tillotts.com ↗
2017-08-08	Zydus Lifesciences Limited	Zydus announces settlement with Aptalis on CANASA (mesalamine suppository, 1 g) zyduslife.com ↗
2017-05-27	Zydus Lifesciences Limited	Zydus Cadila gets USFDA final approval for Mesalamine Delayed-Release Tablets USP, 1.2 g zyduslife.com ↗
2017-05-18	Zeria Pharmaceutical	潰瘍性大腸炎治療剤「アサコール錠400mg」新用法・用量の承認取得に関するお知らせ（PDF ファイル 0.12MB） zeria.co.jp ↗
2017-03-08	Zydus Lifesciences Limited	Zydus wins Federal Circuit Appeal in generic version of Lialda (Mesalamine) zyduslife.com ↗
2016-12-03	Zydus Lifesciences Limited	Zydus Announces Settlement of a DELZICOL zyduslife.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 ↗
2011-02-22	Prasco LLC	Prasco Announces Agreement with Shire for Future Exclusive Distribution and Supply of Authorized Generic for PENTASA® prasco.com ↗
2009-10-16	Zeria Pharmaceutical	潰瘍性大腸炎治療剤「アサコール錠400mg」の製造販売承認取得のお知らせ（PDF ファイル 0.14MB） zeria.co.jp ↗
2007-01-29	Zeria Pharmaceutical	協和発酵工業株式会社との炎症性腸疾患治療剤「ASACOL」（「アサコール」）の共同開発及び共同販売契約の締結について（PDF ファイル 0.12MB） zeria.co.jp ↗
2004-10-01	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Approval Of Mesalamine Rectal Suspension Usp tevapharm.com ↗

Evidence & citations 31 cited values

Every value below carries the sentence it was read from. 159 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 2006 83 “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 ↗ Show 73 more sources
Known as	5-aminosalicylic 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 ↗ 8 “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 “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 (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 ↗ 2 “Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis.” NCT05986136 ↗ “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 ↗ 8 “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 ↗ “Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)” NCT01586533 ↗ “Several oral mesalazine (5-ASA) formulations exist” NCT04133194 ↗
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 2010 13 “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 ↗ NCT00092508 ↗ Show 3 more sources
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	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 ↗ Show 58 more sources
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 2006 1 “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 2006 3 “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 2008 3 “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	multi-matrix mesalamine	“Participants (5-17 years of age; 18-82 kg, stratified by weight) with UC received multi-matrix mesalamine 30, 60, or 100 mg/kg/day once daily (to 4,800 mg/day) for 7 days.” 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 ↗ NCT03399903 ↗ NCT00209300 ↗ NCT00862121 ↗
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 2008 1 “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 2006 5 “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