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 |
|---|---|---|---|---|---|
2025/07/15 | Not Applicable | Not yet recruiting | |||
2025/05/31 | N/A | Not yet recruiting | Xijing Hospital of Digestive Diseases | ||
2025/05/29 | Phase 2 | Recruiting | |||
2024/08/23 | N/A | Completed | |||
2024/07/29 | Early Phase 1 | Not yet recruiting | |||
2024/01/19 | Phase 2 | Recruiting | |||
2024/01/11 | Phase 2 | Recruiting | Mostafa Bahaa | ||
2024/07/24 | Phase 3 | Recruiting | |||
2023/08/15 | Phase 4 | Completed | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | ||
2023/08/14 | Phase 2 | Recruiting | Mostafa Bahaa |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 70771-1513 | RECTAL | 1000 mg in 1 1 | 10/31/2022 | |
| Rising Pharmaceuticals, Inc. | 64980-282 | RECTAL | 1000 mg in 1 1 | 6/5/2019 | |
| Zydus Lifesciences Limited | 70771-1071 | ORAL | 1.2 g in 1 1 | 10/18/2022 | |
| Greenstone LLC | 59762-0117 | ORAL | 400 mg in 1 1 | 1/30/2024 | |
| Allergan, Inc. | 0023-5853 | ORAL | 400 mg in 1 1 | 10/31/2023 | |
| Chartwell RX, LLC | 62135-714 | ORAL | 1.2 g in 1 1 | 7/27/2023 | |
| Takeda Pharmaceuticals America, Inc. | 54092-191 | ORAL | 500 mg in 1 1 | 10/24/2023 | |
| Greenstone LLC | 59762-0118 | RECTAL | 1000 mg in 1 1 | 12/27/2023 | |
| Allergan, Inc. | 58914-501 | RECTAL | 1000 mg in 1 1 | 10/27/2023 | |
| 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 | SIN14428P | GRANULE, DELAYED RELEASE | 1500mg/ sachet | 11/8/2013 | |
| SALOFALK ENEMAS 4 g/60 ml | SIN10918P | ENEMA | 4 g/60 ml | 5/6/1999 | |
| PENTASA PROLONGED RELEASE TABLETS 1G | SIN14479P | TABLET | 1000 mg | 1/9/2014 | |
| PENTASA PROLONGED RELEASE GRANULES 2G/SACHET | SIN14456P | GRANULE, DELAYED RELEASE | 2000 mg | 12/10/2013 | |
| Asacol Tablet 800mg | SIN14275P | TABLET, ENTERIC COATED | 800mg | 12/12/2012 | |
| MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG | SIN14999P | TABLET, DELAYED RELEASE | 1200.0mg | 5/3/2016 | |
| PENTASA RECTAL SUSPENSION 1 G | SIN15137P | SUSPENSION | 0.01g/ml | 12/14/2016 | |
| Salofalk Gastro- resistant Prolonged-release Granules 1g/ sachet | SIN14427P | GRANULE, DELAYED RELEASE | 1000mg/ sachet | 11/8/2013 | |
| PENTASA SUPPOSITORIES 1 g | SIN07740P | SUPPOSITORY | 1 g | 6/15/1994 | |
| Salofalk Gastro-resistant Prolonged-release Granules 500mg/ sachet | SIN14426P | GRANULE, DELAYED RELEASE | 500mg/ sachet | 11/8/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mesalazine Suppositories | 国药准字HJ20150314 | 化学药品 | 栓剂 | 7/5/2024 | |
| Mesalazine Suppositories | 国药准字HJ20140947 | 化学药品 | 栓剂 | 7/5/2024 | |
| Mesalazine Suppositories | 国药准字HJ20150280 | 化学药品 | 栓剂 | 7/5/2024 | |
| Mesalazine Suppositories | 国药准字H20065650 | 化学药品 | 栓剂 | 12/30/2020 | |
| Mesalazine Suppositories | 国药准字HJ20160582 | 化学药品 | 栓剂 | 7/22/2021 | |
| Mesalazine Suppositories | 国药准字HJ20140948 | 化学药品 | 栓剂 | 7/5/2024 | |
| Mesalazine Enemas | 国药准字HJ20150127 | 化学药品 | 灌肠剂 | 7/5/2024 | |
| Mesalazine Sustained-release Tablets | 国药准字HJ20181183 | 化学药品 | 片剂 | 3/20/2023 | |
| Mesalazine Enteric-coated Sustained-release Capsules | 国药准字H20249598 | 化学药品 | 胶囊剂 | 12/1/2024 | |
| Mesalazine Enteric-coated Sustained-release Capsules | 国药准字H20244995 | 化学药品 | 胶囊剂 | 9/26/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SALOFALK GASTRO-RESISTANT PROLONGED-RELEASE GRANULES 3G | N/A | N/A | N/A | 3/20/2017 | |
| SALOFALK 250 TAB 250MG | N/A | N/A | N/A | 12/7/2009 | |
| PENTASA ENEMA 10MG/ML | N/A | 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 | Medicine | A | 4/16/2010 | |
| MESALAZINE SCP mesalazine 1.2 g gastro-resistant prolonged release tablet bottle | 310312 | Medicine | A | 9/2/2021 | |
| SALOFALK ENEMAS mesalazine 2g/60mL enema bottle | 80653 | Medicine | A | 5/15/2002 | |
| SALOFALK GRANULES mesalazine 1.5g modified release granules sachet | 143611 | Medicine | A | 7/14/2008 | |
| PENTASA mesalazine 2 g prolonged release granules sachet | 161064 | Medicine | A | 8/18/2009 | |
| MESALZ mesalazine 1.2 g gastro-resistant prolonged release tablet bottle | 384646 | Medicine | A | 1/5/2023 | |
| MESALAZINE ALIDAC mesalazine 1.2 g delayed release tablet bottle | 442795 | Medicine | A | 3/14/2025 | |
| ZYDASA mesalazine 1.2 g delayed release tablet blister pack | 442796 | Medicine | A | 3/14/2025 | |
| MESALAZINE RMB mesalazine 1.2 g gastro-resistant prolonged release tablet blister pack | 310314 | Medicine | A | 9/2/2021 | |
| PENTASA mesalazine 0.5 g prolonged release tablet blister pack | 99139 | Medicine | A | 1/2/2007 |
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