Overview
Alogliptin is a selective, orally-bioavailable inhibitor of enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt and exists predominantly as the R-enantiomer (>99%). It undergoes little or no chiral conversion in vivo to the (S)-enantiomer. FDA approved January 25, 2013.
Background
Alogliptin is a selective, orally-bioavailable inhibitor of enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt and exists predominantly as the R-enantiomer (>99%). It undergoes little or no chiral conversion in vivo to the (S)-enantiomer. FDA approved January 25, 2013.
Indication
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/10/28 | Phase 3 | Completed | |||
2014/09/03 | Phase 4 | Completed | Kun-Ho Yoon | ||
2014/08/20 | N/A | Completed | |||
2014/02/21 | Phase 3 | Completed | |||
2013/10/17 | N/A | Completed | |||
2013/09/18 | N/A | Completed | |||
2013/09/18 | N/A | Completed | |||
2013/07/01 | Phase 3 | Completed | |||
2012/08/14 | Phase 1 | Completed | |||
2012/06/29 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 45802-238 | ORAL | 12.5 mg in 1 1 | 3/31/2022 | |
| Takeda Pharmaceuticals America, Inc. | 64764-125 | ORAL | 12.5 mg in 1 1 | 7/1/2023 | |
| Takeda Pharmaceuticals America, Inc. | 64764-251 | ORAL | 25 mg in 1 1 | 12/4/2023 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-402 | ORAL | 25 mg in 1 1 | 3/31/2022 | |
| Takeda Pharmaceuticals America, Inc. | 64764-254 | ORAL | 25 mg in 1 1 | 12/4/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Alogliptin Benzoate Tablets | 国药准字H20203635 | 化学药品 | 片剂 | 12/2/2020 | |
| Alogliptin Benzoate Tablets | 国药准字H20223530 | 化学药品 | 片剂 | 7/19/2022 | |
| Alogliptin Benzoate Tablets | 国药准字HJ20130549 | 化学药品 | 片剂 | 10/30/2023 | |
| Alogliptin Benzoate Tablets | 国药准字HJ20130548 | 化学药品 | 片剂 | 10/30/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||