Overview
Saxagliptin (rINN) is an orally active hypoglycemic (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. FDA approved on July 31, 2009.
Background
Saxagliptin (rINN) is an orally active hypoglycemic (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. FDA approved on July 31, 2009.
Indication
Treatment of type 2 diabetes mellitus to improve glycemic control in combination with other agents or as monotherapy.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/30 | Phase 3 | Completed | University of Basrah | ||
2023/10/25 | N/A | Completed | |||
2022/04/26 | N/A | UNKNOWN | |||
2021/10/11 | N/A | Recruiting | |||
2020/08/20 | Phase 4 | Completed | |||
2019/11/20 | Not Applicable | UNKNOWN | |||
2019/05/03 | N/A | Completed | |||
2019/05/01 | Early Phase 1 | Completed | Eric Grouzmann | ||
2018/10/22 | Phase 2 | Completed | |||
2018/09/06 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr.Reddys Laboratories Inc | 43598-619 | ORAL | 5 mg in 1 1 | 7/28/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-8175 | ORAL | 5 mg in 1 1 | 4/22/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-4706 | ORAL | 5 mg in 1 1 | 4/23/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-8177 | ORAL | 5 mg in 1 1 | 4/22/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-8176 | ORAL | 2.5 mg in 1 1 | 4/22/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-4705 | ORAL | 2.5 mg in 1 1 | 4/23/2023 | |
| Dr.Reddys Laboratories Inc | 43598-620 | ORAL | 5 mg in 1 1 | 7/28/2023 | |
| Dr.Reddys Laboratories Inc | 43598-618 | ORAL | 2.5 mg in 1 1 | 7/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/30/2009 | ||
Astra Zeneca AB,51 85 Södertälje,Sweden | Authorised | 7/15/2016 | |
Authorised | 9/30/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Nutritrace Concentrate for solution for infusion | SIN14341P | INFUSION, SOLUTION CONCENTRATE | 6.958mg/10ml | 4/22/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Saxagliptin tablets | 国药准字H20223497 | 化学药品 | 片剂 | 7/7/2022 | |
| Saxagliptin tablets | 国药准字H20193009 | 化学药品 | 片剂 | 12/25/2023 | |
| Saxagliptin tablets | 国药准字HJ20160088 | 化学药品 | 片剂 | 10/20/2020 | |
| Saxagliptin tablets | 国药准字HJ20160090 | 化学药品 | 片剂 | 10/20/2020 | |
| Saxagliptin tablets | 国药准字HJ20160085 | 化学药品 | 片剂 | 10/20/2020 | |
| Saxagliptin tablets | 国药准字H20213188 | 化学药品 | 片剂 | 3/16/2021 | |
| Saxagliptin tablets | 国药准字HJ20160087 | 化学药品 | 片剂 | 10/20/2020 | |
| Saxagliptin tablets | 国药准字H20223775 | 化学药品 | 片剂 | 10/25/2022 | |
| Saxagliptin tablets | 国药准字H20203537 | 化学药品 | 片剂 | 10/27/2020 | |
| Saxagliptin tablets | 国药准字H20223498 | 化学药品 | 片剂 | 7/7/2022 |
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 |
|---|---|---|---|---|---|
| KOMBIGLYZE XR 2.5/1000 tablets 2.5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release | 202207 | Medicine | A | 10/10/2013 | |
| ONGLYZA saxagliptin (as hydrochloride) 5 mg film coated tablet blister pack | 157907 | Medicine | A | 3/18/2011 | |
| ONGLYZA saxagliptin (as hydrochloride) 2.5 mg film-coated tablet blister pack | 211214 | Medicine | A | 3/21/2014 | |
| KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release | 202209 | Medicine | A | 10/10/2013 | |
| QTERN 5/10 saxagliptin (as hydrochloride) / dapagliflozin (as propanediol monohydrate) 5 mg / 10 mg film-coated tablet blister pack | 255632 | Medicine | A | 10/25/2016 | |
| KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release | 202208 | Medicine | A | 10/10/2013 |