Overview
Taspoglutide is a pharmaceutical drug, a glucagon-like peptide-1 agonist (GLP-1 agonist), under investigation for treatment of type 2 diabetes being codeveloped by Ipsen and Roche. In September 2010 Roche halted Phase III clinical trials due to incidences of serious hypersensitivity reactions and gastrointestinal side effects. As of May 2013 no new trials had been registered.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Taspoglutide (DB14027): A Case Study in Efficacy versus Safety
1.0 Executive Summary
Taspoglutide was an investigational, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes mellitus.[1] As a human-sequence-based peptide analog engineered for once-weekly subcutaneous administration, it represented a significant therapeutic advancement in the management of hyperglycemia. Its development was a collaborative effort, originating from research at Tulane University and progressing through a partnership between Ipsen and Roche.[3]
The extensive Phase III clinical trial program, known as T-emerge, demonstrated that Taspoglutide possessed a potent and clinically superior efficacy profile. In head-to-head trials, it achieved significantly greater reductions in glycosylated hemoglobin () and fasting plasma glucose compared to established therapies, including the twice-daily GLP-1 agonist exenatide and the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin.[5] These glycemic benefits were accompanied by the desirable effect of weight loss, consistent with its drug class.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/09/02 | Phase 4 | Completed | |||
2014/08/28 | Phase 4 | Completed | |||
2010/01/18 | Phase 3 | Terminated | |||
2009/11/23 | Phase 3 | Completed | |||
2009/05/28 | Phase 3 | Completed | |||
2009/01/16 | Phase 3 | Completed | |||
2008/12/19 | Phase 1 | Completed | |||
2008/12/17 | Phase 3 | Completed | |||
2008/09/18 | Phase 3 | Completed | |||
2008/09/18 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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