Overview
Canagliflozin, also known as Invokana, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus along with lifestyle changes including diet and exercise . It was initially approved by the FDA in 2013 for the management of diabetes and later approved in 2018 for a second indication of reducing the risk of cardiovascular events in patients diagnosed with type 2 diabetes mellitus , . Canagliflozin is the first oral antidiabetic drug approved for the prevention of cardiovascular events in patients with type 2 diabetes . Cardiovascular disease is the most common cause of death in these patients .
Indication
This drug is used in conjunction with diet and exercise to increase glycemic control in adults diagnosed with type 2 diabetes mellitus . Another indication for canagliflozin is the prevention of major cardiovascular events (myocardial infarction, stroke, or death due to a cardiovascular cause) in patients with type 2 diabetes, as well as hospitalization for heart failure in patients with type 2 diabetes. In addition to the above, canagliflozin can be used to lower the risk of end-stage kidney disease and major increases in serum creatinine and cardiovascular death for patients with a combination of type 2 diabetes mellitus, diabetic nephropathy, and albuminuria. It is important to note that this drug is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis .
Associated Conditions
- Cardiovascular Mortality
- End Stage Renal Disease (ESRD)
- Hospitalizations
- Major Adverse Cardiac Events
- Type 2 Diabetes Mellitus
- Doubling of serum creatinine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Phase 2 | Not yet recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2025/03/05 | Phase 4 | Not yet recruiting | |||
2025/02/28 | Phase 4 | Not yet recruiting | Fundación para la Investigación del Hospital Clínico de Valencia | ||
2024/07/30 | Phase 2 | Recruiting | |||
2024/03/08 | Phase 4 | Completed | AgelessRx | ||
2024/02/13 | Phase 4 | Not yet recruiting | Ping Li,MD | ||
2023/12/27 | Phase 2 | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2023/10/25 | N/A | Completed | |||
2023/06/15 | Not Applicable | Not yet recruiting | Zhang Xiaofeng,MD | ||
2023/05/12 | Phase 4 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Pharmaceuticals, Inc. | 50458-940 | ORAL | 50 mg in 1 1 | 1/30/2024 | |
| Cardinal Health 107, LLC | 55154-1425 | ORAL | 100 mg in 1 1 | 12/13/2018 | |
| A-S Medication Solutions | 50090-5029 | ORAL | 300 mg in 1 1 | 7/12/2023 | |
| Janssen Pharmaceuticals, Inc. | 50458-140 | ORAL | 100 mg in 1 1 | 7/12/2023 | |
| Janssen Pharmaceuticals, Inc. | 50458-540 | ORAL | 50 mg in 1 1 | 1/30/2024 | |
| Janssen Pharmaceuticals, Inc. | 50458-542 | ORAL | 150 mg in 1 1 | 1/30/2024 | |
| Janssen Pharmaceuticals, Inc. | 50458-941 | ORAL | 50 mg in 1 1 | 1/30/2024 | |
| Janssen Pharmaceuticals, Inc. | 50458-543 | ORAL | 150 mg in 1 1 | 1/30/2024 | |
| Janssen Pharmaceuticals, Inc. | 50458-943 | ORAL | 150 mg in 1 1 | 1/30/2024 | |
| A-S Medication Solutions | 50090-4364 | ORAL | 300 mg in 1 1 | 7/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2013 | ||
Authorised | 4/23/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| INVOKANA™ FILM-COATED TABLETS 300 MG | SIN14507P | TABLET, FILM COATED | 300 mg | 2/21/2014 | |
| INVOKANA™ FILM-COATED TABLETS 100 MG | SIN14506P | TABLET, FILM COATED | 100 mg | 2/21/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Canagliflozin Tablets | 国药准字H20223547 | 化学药品 | 片剂 | 7/29/2022 | |
| Canagliflozin Tablets | 国药准字H20243612 | 化学药品 | 片剂 | 4/24/2024 | |
| Canagliflozin Tablets | 国药准字H20233077 | 化学药品 | 片剂 | 1/19/2023 | |
| Canagliflozin Tablets | 国药准字H20193392 | 化学药品 | 片剂 | 12/18/2019 | |
| Canagliflozin Tablets | 国药准字H20233076 | 化学药品 | 片剂 | 1/19/2023 | |
| Canagliflozin Tablets | 国药准字H20193393 | 化学药品 | 片剂 | 12/18/2019 | |
| Canagliflozin Tablets | 国药准字H20213674 | 化学药品 | 片剂 | 8/25/2021 | |
| Canagliflozin Tablets | 国药准字H20233741 | 化学药品 | 片剂 | 6/21/2023 | |
| Canagliflozin Tablets | 国药准字H20244327 | 化学药品 | 片剂 | 6/28/2024 | |
| Canagliflozin Tablets | 国药准字H20233014 | 化学药品 | 片剂 | 1/9/2023 |
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. | |||||
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