Overview
Lubiprostone is a medication used in the management of idiopathic chronic constipation. A prostaglandin E1 derivative, lubiprostone is a bicyclic fatty acid that activates ClC-2 chloride channels located on the apical side of the gastrointestinal epithelial cells. Activation of these channels promotes the secretion of a chloride-rich fluid that soften the stool, increase gastrointestinal motility, and induce spontaneous bowel movements (SBM).
Indication
Lubiprostone is indicated for the treatment of adult patients with chronic idiopathic constipation, or opioid-induced constipation in patients with chronic non-cancer pain. It is also indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in female patients ≥18 years old.
Associated Conditions
- Irritable Bowel Syndrome With Constipation (IBS-C)
- Opioid Induced Constipation (OIC)
- Chronic idiopathic constipation (CIC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/09 | Phase 1 | Recruiting | |||
2023/03/14 | Phase 3 | Completed | |||
2021/12/03 | Phase 3 | Completed | |||
2018/10/25 | N/A | Recruiting | BioDelivery Sciences International | ||
2017/03/31 | Phase 3 | Completed | |||
2016/05/10 | Phase 3 | Completed | |||
2016/04/06 | Phase 3 | Completed | |||
2016/03/01 | Phase 3 | Completed | |||
2016/01/08 | Phase 3 | Completed | |||
2015/09/09 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Quality Care Products, LLC | 83008-001 | ORAL | 24 ug in 1 1 | 4/20/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1642 | ORAL | 24 ug in 1 1 | 3/27/2023 | |
| Zydus Lifesciences Limited | 70771-1763 | ORAL | 8 ug in 1 1 | 3/24/2023 | |
| Amneal Pharmaceuticals LLC | 65162-841 | ORAL | 8 ug in 1 1 | 2/7/2023 | |
| Par Pharmaceutical Inc. | 0254-3029 | ORAL | 24 ug in 1 1 | 11/1/2020 | |
| SPECGX LLC | 23635-524 | ORAL | 24 ug in 1 1 | 1/31/2024 | |
| Direct_Rx | 72189-410 | ORAL | 8 ug in 1 1 | 1/12/2023 | |
| Lake Erie Medical DBA Quality Care Products LLC | 35356-500 | ORAL | 24 ug in 1 1 | 12/19/2018 | |
| Sun Pharmaceutical Industries, Inc. | 63304-352 | ORAL | 24 ug in 1 1 | 1/1/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-3479 | ORAL | 8 ug in 1 1 | 5/27/2022 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| AMITIZA | 02447363 | Capsule - Oral | 24 MCG | N/A |
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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