mesalamine
Trade name: rowasa
Approved
Dec 24, 1987
Mesalamine, also known as Mesalazine or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammation of the digestive tract (Crohn's disease) and mild to moderate ulcerative colitis. Mesalazine is a bowel-specific aminosalicylate drug that is metabolized in the gut and has its predominant actions there, thereby having fewer systemic side effects. As a derivative of salicylic acid, 5-ASA is also an antioxidant that traps free radicals, which are potentially damaging by-products of metabolism. Although the mechanism of action of mesalazine is not fully understood, it appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon. Mesalazine is used for the treatment of active ulcerative proctitis. — NCATS
Clinical trial activity
140 trials · 146 clinical orgs · 34 marketing orgs
Earliest trial started Sep 1, 2000 (NCT00073021)
Timeline
1980s
1990s
- Dec 18, 1990
Meda Pharmaceuticals — NDA Secondary Org
- Jan 31, 1992
SmithKline Beecham — NDA Secondary Org
- May 10, 1993
Shire — NDA Secondary Org
- May 10, 1993
Takeda — Marketing Organization
- May 10, 1993
Takeda — NDA Secondary Org
2000s
- Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
- Jan 5, 2001
Allergan — NDA Secondary Org
- Jan 5, 2001
Allergan — Marketing Organization
- Jan 5, 2001
AbbVie — Marketing Organization
- Jan 5, 2001
AbbVie — NDA Secondary Org
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2003
- Sep 17, 2004
Perrigo — Marketing Organization
- Sep 17, 2004
Padagis Us — Marketing Organization
- Sep 30, 2004
G & W Laboratories Inc. — Marketing Organization
- Oct 31, 2008
Bausch Health Companies — NDA Secondary Org
- Oct 31, 2008
Salix — Marketing Organization
2010s
- Nov 24, 2015
Mylan — Marketing Organization
- Nov 24, 2015
Quagen Pharma — Marketing Organization
- Jun 5, 2017
Zydus Discovery DMCC — Marketing Organization
- Jul 24, 2017
Sandoz — Marketing Organization
- Aug 23, 2017
Amring Pharmaceticals — Marketing Organization
- Mar 23, 2018
Actavis — Marketing Organization
- Mar 23, 2018
Allergan PLC (2015) — Marketing Organization
- Jul 11, 2018
Teva — Marketing Organization
- Nov 9, 2018
Pharma Sourcing Partners — Marketing Organization
- Jan 25, 2019
Sun Pharmaceuticals — Marketing Organization
- Apr 19, 2019
Rising Pharmaceuticals — Marketing Organization
- Apr 19, 2019
Aptapharma Inc — Marketing Organization
- Jun 12, 2019
Novartis — Marketing Organization
2020s
- Jan 2, 2020
Amneal Pharmaceuticals — Marketing Organization
- Mar 19, 2020
Annora Pharma — Marketing Organization
- Jul 15, 2021
Alkem Labs Ltd — Marketing Organization
- Oct 28, 2022
Alembic — Marketing Organization
- Mar 31, 2023
Aurobindo Pharma — Marketing Organization
- May 12, 2023
Sinotherapeutics — Marketing Organization
- May 30, 2023
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Jun 6, 2023
Amta — Marketing Organization
- Aug 22, 2024
Novast Labs — Marketing Organization
- Apr 16, 2025
Novitium Pharma — Marketing Organization
Indications
Approved for
Studied for
- Acquired Immunodeficiency Syndrome · Phase 4
- Adenoma · Phase 2
- Beryllium · Phase 1/Phase 2
- Breast Neoplasms · Phase 2
- Cocaine-Related Disorders · Phase 2
- Colitis · Phase 2
- Colitis, Collagenous · Phase 3
- Colitis, Lymphocytic · Phase 3
- Colitis, Microscopic · Phase 2/Phase 3
- Colitis, Ulcerative · Phase 4
- Colonic Neoplasms · Phase 4
- Colorectal Neoplasms · Phase 2
- Colorectal Neoplasms, Hereditary Nonpolyposis · Phase 2
- Crohn Disease · Phase 4
- Cytokines · Phase 2
- Diabetes Mellitus, Type 2 · Phase 1
- Dialysis · Phase 1
- Diarrhea · Phase 2/Phase 3
- Digestive System Diseases · Phase 2/Phase 3
- Diverticular Diseases · Phase 3
- Diverticulitis · Phase 3
- Diverticulosis, Colonic · Phase 2
- Drug Evaluation · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Eosinophilic Esophagitis · Phase 2
- Fissure in Ano · Phase 1/Phase 2
- Gastrointestinal Diseases · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Hermanski-Pudlak Syndrome · Phase 2
- HIV Infections · Phase 4
- Immune System Diseases · Phase 4
- Inflammation · Phase 1/Phase 2
- Inflammatory Bowel Diseases · Phase 2/Phase 3
- Intestinal Diseases · Phase 2/Phase 3
- Intestinal Neoplasms · Phase 4
- Irritable Bowel Syndrome · Phase 4
- Kidney Failure, Chronic · Phase 1
- Lentivirus Infections · Phase 4
- Lymphocytes · Phase 2
- Malnutrition · Phase 1/Phase 2
- Melanoma · Phase 2
- Metabolism · Phase 2
- Obesity · Phase 1
- Oral Ulcer · Phase 3
- Polycystic Ovary Syndrome · Phase 2
- Proctitis · Phase 3
- Quality of Life · Phase 4
- Rectal Neoplasms · Phase 2
- Recurrence · Phase 3
- Renal Dialysis · Phase 1
- Schizophrenia · Phase 3
- Sexually Transmitted Diseases · Phase 4
Mechanism of action
- UnclearUnclear
Unclear unclear
Approval history
- approvedPriority reviewDec 24, 1987
Chemistry & pharmacology
SMILES
NC1=CC=C(O)C(=C1)C(O)=O- Mol. weight
- 153.1354 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
Yes
Sources
- WikipediaMesalazine ↗
- NCATS4Q81I59GXC ↗
- ChEMBLCHEMBL704 ↗
Also known as
- 2-hydroxy-5-aminobenzoic acid
- 3-carboxy-4-hydroxyaniline
- 3-carboxy-4-hydroxyaniline
- 3-carboxy-4-hydroxyaniline
- 5-amino-2-hydroxybenzoic acid
- 5-aminosalicylic acid
- 5-aminosalicylic acid
- 5-aminosalicylic acid
- 5-aminosalicylic acid
- 5asa
- 5-asa
- 5-asa
- 5-asa
- 5-asa
- 5-asa
- 5-asa
- alth12
- apriso
- apriso
- asacol
- asacol
- asacol hd
- asacol hd
- asacolitin
- asacolitin
- canasa
- canasa
- claversal
- claversal
- claversal
- coltec ec
- delzicol
- delzicol
- fisalamine
- fisalamine
- fisalamine
- iialda
- iialda
- ipocol
- ipocol
- lialda
- lialda
- lixacol
- lixacol
- m-aminosalicylic acid
- m-aminosalicylic acid
- m-aminosalicylic acid
- mesacol
- mesalamin
- mesalamine
- mesalamine
- mesalamine
- mesalamine
- mesalamine
- mesalamine
- mesalamine
- mesalamine hcl
- mesalamine hydrochloride
- mesalazina
- mesalazina
- mesalazine
- mesalazine
- mesalazine
- mesalazine
- mesalazinum
- mesalazinum
- mesalsal
- mesasal
- mesasal
- mesasal
- mesren mr
- mezavant xl
- mezavant xl
- nac
- n-acetylcysteine
- octasa
- p-aminosalicylsaeure
- p-aminosalicylsaeure
- pentasa
- pentasa
- pentasa sr
- rowasa
- rowasa
- rowasa
- salofalk
- salofalk
- sfrowasa
- sfrowasa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07064707 | Phase 2 | Jul 15, 2025 | Alexandria University, Kafrelsheikh University |
| NCT06993974 | Phase 2 | May 30, 2025 | Alexandria University, Kafrelsheikh University |
| NCT06625450 | Phase 4 | Oct 31, 2024 | Postgraduate Institute of Medical Education and Research |
| NCT06667934 | Phase 1/Phase 2 (Phase 2) | Oct 30, 2024 | Anhui Medical University |
| NCT06525974 | Early Phase 1 (Phase 1) | Sep 1, 2024 | Tanta University |
| NCT06067698 | N/A | Oct 1, 2023 | Tanta University |
| NCT05986136 | Phase 2/Phase 3 (Phase 3) | Aug 20, 2023 | Tanta University |
| NCT05663775 | Phase 2 | Apr 30, 2023 | University of Calgary |
| NCT05781698 | Phase 2 | Mar 20, 2023 | Menoufia University, Tanta University |
| NCT05753267 | Phase 2/Phase 3 (Phase 3) | Feb 28, 2023 | Menoufia University, Tanta University |
| NCT05567068 | Phase 2 | Feb 1, 2023 | Tanta University |
| NCT05316220 | Phase 3 | Dec 31, 2022 | AbbVie |
| NCT05488405 | Phase 2 | Nov 30, 2022 | Dr. Falk Pharma GmbH |
| NCT05119140 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2021 | Crohn's and Colitis Foundation, Emory University, Icahn School of Medicine at Mount Sinai |
| NCT04920149 | Phase 2 | Aug 9, 2021 | Karolinska Institute, Medical University of Vienna, The Swedish Research Council |
| NCT05091775 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2020 | Shiraz University |
| NCT04259138 | Phase 4 | Feb 29, 2020 | Takeda, University of Western Ontario |
| NCT03716388 | Phase 3 | Dec 1, 2018 | Dayanand Medical College |
| NCT03185624 | Phase 3 | Jun 12, 2017 | Huazhong University of Science and Technology, Jiao Tong University, People's Liberation Army of China, Sun Yat-Sen University, Tsinghua University, Zhejiang University |
| NCT03327558 | Phase 1 | May 15, 2017 | Bausch Health Companies |
Organizations
Research & Development (146)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shire | For profit | 18 | 16 | 4 | 2003 |
| Dr. Falk Pharma GmbH | For profit | 14 | 14 | 2 | 2002 |
| Procter and Gamble | For profit | 12 | 0 | 5 | 2000 |
| Warner Chilcott | For profit | 9 | 9 | 3 | 2000 |
| Bausch Health Companies | For profit | 8 | 7 | 4 | 2004 |
| Ferring | For profit | 7 | 7 | 1 | 2005 |
| People's Liberation Army of China | Government | 6 | 2 | 3 | 2012 |
| Tanta University | Academic/Hospital | 6 | 6 | 4 | 2023 |
| Tillotts Pharma | For profit | 6 | 4 | 3 | 2009 |
| Evang. Krankenhaus Kalk | Academic/Hospital | 4 | 0 | 2 | 2005 |
| SOFAR S.p.A. | For profit | 4 | 4 | 2 | 2004 |
| Imelda Hospital, Bonheiden | Academic/Hospital | 3 | 0 | 3 | 2003 |
| Mayo Clinic | Academic/Hospital | 3 | 1 | 2 | 2005 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 3 | 1 | 2 | 2007 |
| Alexandria University | Academic/Hospital | 2 | 2 | 1 | 2025 |
| Altheus Therapeutics, Inc. | For profit | 2 | 2 | 2 | 2009 |
| Huazhong University of Science and Technology | Academic/Hospital | 2 | 0 | 2 | 2017 |
| Kafrelsheikh University | Academic/Hospital | 2 | 0 | 1 | 2025 |
| Karolinska Institute | Academic/Hospital | 2 | 0 | 1 | 2012 |
| Medical University of Vienna | Academic/Hospital | 2 | 2 | 1 | 2017 |
Marketing (50)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Jan 5, 2001 |
| AbbVie | For profit | NDA2 | Jan 5, 2001 |
| Actavis | For profit | MKTG | Mar 23, 2018 |
| Actavis | For profit | SYN | Aug 14, 2020 |
| Alembic | For profit | MKTG | Oct 28, 2022 |
| Alembic | For profit | SYN | Oct 28, 2022 |
| Alkem Labs Ltd | For profit | MKTG | Jul 15, 2021 |
| Allergan | For profit | NDA2 | Jan 5, 2001 |
| Allergan | For profit | SYN | Jan 31, 1992 |
| Allergan | For profit | MKTG | Jan 5, 2001 |
| Allergan PLC (2015) | For profit | MKTG | Mar 23, 2018 |
| Amneal Pharmaceuticals | For profit | MKTG | Jan 2, 2020 |
| Amneal Pharmaceuticals | For profit | SYN | Jan 2, 2020 |
| Amring Pharmaceticals | For profit | MKTG | Aug 23, 2017 |
| Amta | For profit | MKTG | Jun 6, 2023 |
| Annora Pharma | For profit | MKTG | Mar 19, 2020 |
| Aptapharma Inc | For profit | MKTG | Apr 19, 2019 |
| Aurobindo Pharma | For profit | MKTG | Mar 31, 2023 |
| Bausch Health Companies | For profit | NDA2 | Oct 31, 2008 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | May 30, 2023 |
| G & W Laboratories Inc. | For profit | MKTG | Sep 30, 2004 |
| Meda Pharmaceuticals | For profit | NDA2 | Dec 18, 1990 |
| Mylan | For profit | NDA2 | Dec 24, 1987 |
| Mylan | For profit | MKTG | Nov 24, 2015 |
| Mylan | For profit | SYN | Nov 24, 2015 |
| Mylan | For profit | NDA | Dec 24, 1987 |
| Novartis | For profit | MKTG | Jun 12, 2019 |
| Novast Labs | For profit | MKTG | Aug 22, 2024 |
| Novitium Pharma | For profit | MKTG | Apr 16, 2025 |
| Padagis Us | For profit | MKTG | Sep 17, 2004 |
| Perrigo | For profit | MKTG | Sep 17, 2004 |
| Pharma Sourcing Partners | For profit | MKTG | Nov 9, 2018 |
| Pharma Sourcing Partners | For profit | SYN | Apr 19, 2019 |
| Quagen Pharma | For profit | MKTG | Nov 24, 2015 |
| Rising Pharmaceuticals | For profit | MKTG | Apr 19, 2019 |
| Salix | For profit | MKTG | Oct 31, 2008 |
| Sandoz | For profit | MKTG | Jul 24, 2017 |
| Sandoz | For profit | SYN | Jun 12, 2019 |
| Shire | For profit | NDA2 | May 10, 1993 |
| Sinotherapeutics | For profit | MKTG | May 12, 2023 |
| SmithKline Beecham | For profit | NDA2 | Jan 31, 1992 |
| Sun Pharmaceuticals | For profit | SYN | Jan 25, 2019 |
| Sun Pharmaceuticals | For profit | MKTG | Jan 25, 2019 |
| Takeda | For profit | MKTG | May 10, 1993 |
| Takeda | For profit | NDA2 | May 10, 1993 |
| Teva | For profit | SYN | Aug 22, 2024 |
| Teva | For profit | MKTG | Jul 11, 2018 |
| Teva | For profit | SYN | May 9, 2019 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 5, 2017 |
| Zydus Discovery DMCC | For profit | SYN | Nov 29, 2018 |