Mesalazine

Overview

An anti-inflammatory agent, structurally related to the salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid, which is active in inflammatory bowel disease . Although demonstrably effective in treating and maintaining remission for ulcerative colitis, mesalazine has historically faced a number of issues regarding its lack of stability as a pharmaceutical agent . Throughout the late seventies and the eighties, important research initiatives developed stable mesalazine formulations like the eudragit-S coating of Asacol brand mesalazine and the Pentasa brand's encapsulation of mesalazine within microgranules . In the present day, contemporary research regarding novel methods to stabilize mesalazine continues and interest in the agent's capacity to decrease inflammatory activity and subsequently potentially reduce the risk of colorectal cancer in conditions like ulcerative colitis is maintained.

Indication

适用于溃疡性结肠炎和克罗恩病（Crohn病）。

Associated Conditions

Acute Ulcerative Colitis
Crohn's Disease Relapse
Crohn's Ileocolitis
Mild to Moderate Ulcerative Colitis
Proctitis
Proctitis, Ulcerative
Proctosigmoiditis
Ulcerative Colitis in Remission
Mild Ulcerative Colitis
Mild to moderate distal ulcerative colitis
Moderate Ulcerative colitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Rupatadine in Patients With Ulcerative Colitis	2025/07/15	NCT07064707	Not Applicable	Not yet recruiting	Alexandria University
A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis	2025/05/31	NCT06998693	N/A	Not yet recruiting	Xijing Hospital of Digestive Diseases
Nitazoxanide in Patients With Ulcerative Colitis	2025/05/29	NCT06993974	Phase 2	Recruiting	Alexandria University
Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis	2024/08/23	NCT06568224	N/A	Completed	The First Affiliated Hospital with Nanjing Medical University
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine	2024/07/29	NCT06525974	Early Phase 1	Not yet recruiting	Tanta University
Beneficial Effect of Silymarin in Ulcerative Colitis	2024/01/19	NCT06213857	Phase 2	Recruiting	Tanta University
Minocyclin in Ulcerative Colitis as Added on Therapy	2024/01/11	NCT06201793	Phase 2	Recruiting	Mostafa Bahaa
A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.	2024/07/24	2023-509606-30-00	Phase 3	Recruiting	Faes Farma S.A.
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA	2023/08/15	NCT05992142	Phase 4	Completed	Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis	2023/08/14	NCT05988528	Phase 2	Completed	Mostafa Bahaa

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mesalamine	Zydus Lifesciences Limited	70771-1513	RECTAL	1000 mg in 1 1	10/31/2022
Mesalamine	Rising Pharmaceuticals, Inc.	64980-282	RECTAL	1000 mg in 1 1	6/5/2019
mesalamine	Zydus Lifesciences Limited	70771-1071	ORAL	1.2 g in 1 1	10/18/2022
MESALAMINE	Greenstone LLC	59762-0117	ORAL	400 mg in 1 1	1/30/2024
Delzicol	Allergan, Inc.	0023-5853	ORAL	400 mg in 1 1	10/31/2023
Mesalamine	Chartwell RX, LLC	62135-714	ORAL	1.2 g in 1 1	7/27/2023
Pentasa	Takeda Pharmaceuticals America, Inc.	54092-191	ORAL	500 mg in 1 1	10/24/2023
Mesalamine	Greenstone LLC	59762-0118	RECTAL	1000 mg in 1 1	12/27/2023
Canasa	Allergan, Inc.	58914-501	RECTAL	1000 mg in 1 1	10/27/2023
Mesalamine	Camber Pharmaceuticals, Inc.	31722-043	ORAL	1.2 g in 1 1	2/15/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Salofalk Gastro-resistant Prolonged-release Granules 1.5g/ sachet	Losan Pharma GmbH, Losan Pharma GmbH (Primary packager and Secondary packager)	SIN14428P	GRANULE, DELAYED RELEASE	1500mg/ sachet	11/8/2013
SALOFALK ENEMAS 4 g/60 ml	Corden Pharma Fribourg AG, Zweigniederlassung Ettingen, Losan Pharma GmbH - Werk Neuenburg	SIN10918P	ENEMA	4 g/60 ml	5/6/1999
PENTASA PROLONGED RELEASE TABLETS 1G	Ferring International Center SA, Pharbil Pharma GmbH	SIN14479P	TABLET	1000 mg	1/9/2014
PENTASA PROLONGED RELEASE GRANULES 2G/SACHET	Ferring International Center SA	SIN14456P	GRANULE, DELAYED RELEASE	2000 mg	12/10/2013
Asacol Tablet 800mg	Haupt Pharma Wulfing GmbH	SIN14275P	TABLET, ENTERIC COATED	800mg	12/12/2012
MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG	COSMO S.P.A.	SIN14999P	TABLET, DELAYED RELEASE	1200.0mg	5/3/2016
PENTASA RECTAL SUSPENSION 1 G	Ferring-Léčiva, a.s.	SIN15137P	SUSPENSION	0.01g/ml	12/14/2016
Salofalk Gastro- resistant Prolonged-release Granules 1g/ sachet	Losan Pharma GmbH, Losan Pharma GmbH (Primary packager and Secondary packager)	SIN14427P	GRANULE, DELAYED RELEASE	1000mg/ sachet	11/8/2013
PENTASA SUPPOSITORIES 1 g	Ferring International Center SA (Primary and Secondary Packager), Ferring International Center SA	SIN07740P	SUPPOSITORY	1 g	6/15/1994
Salofalk Gastro-resistant Prolonged-release Granules 500mg/ sachet	Losan Pharma GmbH, Losan Pharma GmbH (Primary packager and Secondary packager)	SIN14426P	GRANULE, DELAYED RELEASE	500mg/ sachet	11/8/2013

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SALOFALK GASTRO-RESISTANT PROLONGED-RELEASE GRANULES 3G	N/A	A. Menarini Hong Kong Limited	N/A	N/A	3/20/2017
SALOFALK 250 TAB 250MG	N/A	A. Menarini Hong Kong Limited	N/A	N/A	12/7/2009
PENTASA ENEMA 10MG/ML	N/A	Ferring Pharmaceuticals, Inc.	N/A	N/A	7/15/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PENTASA mesalazine 1 g prolonged release tablet blister pack	164142	Ferring Pharmaceuticals Pty Ltd	Medicine	A	4/16/2010
MESALAZINE SCP mesalazine 1.2 g gastro-resistant prolonged release tablet bottle	310312	Southern Cross Pharma Pty Ltd	Medicine	A	9/2/2021
SALOFALK ENEMAS mesalazine 2g/60mL enema bottle	80653	Dr Falk Pharma Australia Pty Ltd	Medicine	A	5/15/2002
SALOFALK GRANULES mesalazine 1.5g modified release granules sachet	143611	Dr Falk Pharma Australia Pty Ltd	Medicine	A	7/14/2008
PENTASA mesalazine 2 g prolonged release granules sachet	161064	Ferring Pharmaceuticals Pty Ltd	Medicine	A	8/18/2009
MESALZ mesalazine 1.2 g gastro-resistant prolonged release tablet bottle	384646	Sun Pharma ANZ Pty Ltd	Medicine	A	1/5/2023
MESALAZINE ALIDAC mesalazine 1.2 g delayed release tablet bottle	442795	KSJ Pharmatech	Medicine	A	3/14/2025
ZYDASA mesalazine 1.2 g delayed release tablet blister pack	442796	KSJ Pharmatech	Medicine	A	3/14/2025
MESALAZINE RMB mesalazine 1.2 g gastro-resistant prolonged release tablet blister pack	310314	Southern Cross Pharma Pty Ltd	Medicine	A	9/2/2021
PENTASA mesalazine 0.5 g prolonged release tablet blister pack	99139	Ferring Pharmaceuticals Pty Ltd	Medicine	A	1/2/2007

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SALOFALK	Abbvie Corporation	02112809	Suspension - Rectal	4 G / 60 G	12/31/1995
PENTASA	Ferring Inc	02399466	Tablet (Extended-Release) - Oral	1 G	3/12/2013
5-ASA	sanis health inc	02351463	Tablet (Enteric-Coated) - Oral	400 MG	11/2/2010
SALOFALK	Abbvie Corporation	02242146	Suppository - Rectal	1000 MG	6/1/2000
SALOFALK	Abbvie Corporation	02112760	Suppository - Rectal	500 MG	12/31/1995
MEZERA	avir pharma inc.	02474026	Foam - Rectal	1 G / ACT	7/13/2018
SALOFALK	Abbvie Corporation	02112787	Tablet (Delayed-Release) - Oral	500 MG	12/31/1995
OCTASA	Tillotts Pharma Ag	02465752	Tablet (Delayed-Release) - Oral	800 MG	9/28/2022
MESALAMINE	Tillotts Pharma Ag	02552426	Tablet (Delayed-Release) - Oral	800 MG	N/A
MESASAL	GlaxoSmithKline Inc	01914030	Tablet (Enteric-Coated) - Oral	500 MG	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PENTASA 4 G GRANULADO DE LIBERACION PROLONGADA	Ferring S.A.	79555	GRANULADO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
MECOLVIX 1.000 MG COMPRIMIDOS GASTRORRESISTENTES	Faes Farma S.A.	85738	COMPRIMIDO GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
ASACOL 800 MG COMPRIMIDOS GASTRORRESISTENTES	Tillotts Pharma Spain S.L.U.	78448	COMPRIMIDO GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
ASACOL 1.600 MG COMPRIMIDOS GASTRORRESISTENTES	Tillotts Pharma Spain S.L.U.	86315	COMPRIMIDO GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PENTASA 1 G SUSPENSION RECTAL	Ferring S.A.	60853	SUSPENSIÓN RECTAL	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PENTASA 1g GRANULADO DE LIBERACION PROLONGADA	Ferring S.A.	62670	GRANULADO DE LIBERACIÓN MODIFICADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
SALOFALK 1 g ESPUMA RECTAL	Dr. Falk Pharma Gmbh	70453	ESPUMA RECTAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
MECOLVIX 500 MG COMPRIMIDOS GASTRORRESISTENTES	Faes Farma S.A.	84675	COMPRIMIDO GASTRORRESISTENTE	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
SALOFALK 1,5 g GRANULADO DE LIBERACION PROLONGADA	Dr. Falk Pharma Gmbh	70134	GRANULADO DE LIBERACIÓN MODIFICADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
MEZAVANT 1200mg comprimidos de liberacion prolongada gastrorresistentes	Giuliani S.P.A.	37734011	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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