Overview
Trimebutine is a spasmolytic agent that regulates intestinal and colonic motility and relieves abdominal pain with antimuscarinic and weak mu opioid agonist effects. It is marketed for the treatment of irritable bowel syndrome (IBS) and lower gastrointestinal tract motility disorders, with IBS being one of the most common multifactorial GI disorders . It is used to restore normal bowel function and is commonly present in pharmaceutical mixtures as trimebutine maleate salt form. Trimebutine is not a FDA-approved drug, but it is available in Canada and several other international countries.
Indication
Indicated for symptomatic treatment of irritable bowel syndrome (IBS) and treatment of postoperative paralytic ileus following abdominal surgery.
Associated Conditions
- Irritable Bowel Syndrome (IBS)
- Gastrointestinal spasms
- Postoperative paralytic ileus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/21 | Phase 1 | Recruiting | |||
2020/05/27 | Phase 4 | Completed | Chuncheon Sacred Heart Hospital | ||
2017/12/02 | Phase 2 | Completed | Hospital Britanico | ||
2017/01/30 | Not Applicable | Suspended | |||
2016/12/08 | Phase 4 | Withdrawn | Xijing Hospital of Digestive Diseases | ||
2013/11/15 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| DEBRIDAT TABLET 100 mg | SIN02931P | TABLET | 100 mg | 5/22/1989 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MODULON TAB 100MG | axcan pharma inc | 00587869 | Tablet - Oral | 100 MG | 12/31/1983 |
| MODULON | Aptalis Pharma Canada ULC | 00803499 | Tablet - Oral | 200 MG | 12/31/1991 |
| MINT-TRIMEBUTINE | mint pharmaceuticals inc | 02538202 | Tablet - Oral | 100 MG | 1/17/2024 |
| APO-TRIMEBUTINE | 02245663 | Tablet - Oral | 100 MG | 10/21/2002 | |
| MODULON INJ 50MG/5ML | axcan pharma inc | 00587850 | Liquid - Intravenous
,
Intramuscular | 10 MG / 1 ML | 12/31/1983 |
| APO-TRIMEBUTINE | 02245664 | Tablet - Oral | 200 MG | 10/21/2002 | |
| MINT-TRIMEBUTINE | mint pharmaceuticals inc | 02538210 | Tablet - Oral | 200 MG | 1/17/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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