Product Description
5-aminosalicylic acid (5-ASA) preparations (eg, mesalazine, mesalamine) are well-established preparations used in the management of inflammatory bowel disease. These drugs are most useful for the treatment of mild to moderate flares of ulcerative colitis and, especially, for maintenance of remission.
Mechanisms of Action: 5-LOX Inhibitor,COX Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Colitis | Colitis, Ulcerative | Colitis | Colitis, Ulcerative
Known Adverse Events: Abdominal Pain | Back Pain | Dizziness | Headache | Pain Unspecified | Nasopharyngitis | Pharyngitis | Rhinitis | Sinusitis | Constipation | Diarrhea | Eructation | Colitis | Colitis, Ulcerative
Company: Ferring
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, Czech Republic, France, Hungary, Japan, Poland, Puerto Rico, Slovakia, Spain, Switzerland, United States
Active Clinical Trial Count: 12
Highest Development Phases
Phase 3: Adenoma|Colitis, Ulcerative|Familial Adenomatous Polyposis
Phase 2: Colorectal Cancer|Eosinophilic Esophagitis|Healthy Volunteers|Lyme Disease
Phase 1: Oral Ulcer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MesaCAPP | P2 |
Active, not recruiting |
Colorectal Cancer |
2045-10-23 |
|
| M21-517 | P3 |
Not yet recruiting |
Colitis, Ulcerative |
2026-07-19 |
41% |
| CGRA-0121/ES | P3 |
Unknown Status |
Colitis, Ulcerative |
2025-09-30 |
|
| CGRA-0121/ES | P3 |
Not yet recruiting |
Colitis, Ulcerative |
2025-08-01 |
70% |