Overview
Olsalazine is an aminosalicylate and a prodrug of mesalamine (5-aminosalicylic acid, 5-ASA). It was first developed for delivering mesalamine to the colon without the use of sulfapyridine. Olsalazine comprises two mesalamine molecules joined by an azo bridge, which is cleaved in the colon. Olsalazine is an anti-inflammatory agent that works by inhibiting cyclooxygenase and lipoxygenase, subsequently reducing the production of pro-inflammatory factors like prostaglandin and leukotriene. Olsalazine is used in the treatment of ulcerative colitis.
Background
Olsalazine is an aminosalicylate and a prodrug of mesalamine (5-aminosalicylic acid, 5-ASA). It was first developed for delivering mesalamine to the colon without the use of sulfapyridine. Olsalazine comprises two mesalamine molecules joined by an azo bridge, which is cleaved in the colon. Olsalazine is an anti-inflammatory agent that works by inhibiting cyclooxygenase and lipoxygenase, subsequently reducing the production of pro-inflammatory factors like prostaglandin and leukotriene. Olsalazine is used in the treatment of ulcerative colitis.
Indication
In the US, olsalazine is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant to sulfasalazine. In Canada, it is used in the treatment of acute ulcerative colitis of mild to moderate severity, with or without the concomitant use of steroids. It is also indicated for the long-term maintenance of patients with ulcerative colitis in remission.
Associated Conditions
- Ulcerative Colitis
- Mild Acute Ulcerative Colitis
- Moderate Acute Ulcerative Colitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
1999/10/19 | Phase 2 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meda Pharmaceuticals Inc. | 0037-6860 | ORAL | 250 mg in 1 1 | 6/15/2022 | |
| Carilion Materials Management | 68151-0312 | ORAL | 250 mg in 1 1 | 5/15/2015 | |
| Carilion Materials Management | 68151-3120 | ORAL | 250 mg in 1 1 | 10/5/2009 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Olsalazine Sodium Capsules | 国药准字H20133213 | 化学药品 | 胶囊剂 | 8/8/2023 | |
| Olsalazine Sodium Capsules | 国药准字H20010061 | 化学药品 | 胶囊剂 | 6/12/2020 | |
| Olsalazine Sodium Capsules | 国药准字H20000247 | 化学药品 | 胶囊剂 | 9/24/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Dipentum 250mg Capsules | 14466 | Medicine | A | 9/5/1991 | |
| DIPENTUM olsalazine sodium 500mg tablet bottle | 53582 | Medicine | A | 9/28/1995 |