Drugs / Forxiga
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | FARXIGA | — | 2015-03-11 – 2024-06-12 | fda.gov ↗ |
| Approved | US (FDA) | FARXIGA | — | 2014-01-08 | fda.gov ↗ |
| Approved | EU (EMA) | Forxiga | — | 2012-11-11 | europa.eu ↗ |
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04473417 | Aug 2020 | — | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04970940 | Jul → Oct 2020 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07096986 | Nov 2026 → Nov 2027 expected | glomerulonephritis | Centre Hospitalier Universitaire de Nice | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04049110 | Aug 2020 → Apr 2023 | type 1 diabetes mellitus | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02561130 | Dec 2015 → Jul 2017 | type 2 diabetes mellitus | Population Health Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02429258 | May → Oct 2015 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07225465 Comparator | Feb 2026 → Feb 2028 expected | type 1 diabetes mellitus | St Vincent's Hospital Melbourne | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06560333 Comparator | Nov 2026 → Apr 2027 | type 2 diabetes mellitus | Eurofarma Laboratorios S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03766750 Comparator | Dec 2021 → Oct 2023 | type 2 diabetes mellitus | EMS | Withdrawn | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07143773 Comparator | Sep 2025 → Jun 2027 expected | disease related to solid organ transplantation | Odense University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06417320 Comparator | Jun 2023 → Jan 2025 | nephrotic syndrome | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT05743907 Comparator | Apr 2023 → Mar 2025 | diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04193566 Comparator | Feb → Sep 2020 | diabetic autonomic neuropathy, diabetic kidney disease, mitochondrial disease, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-06-12 | AstraZeneca | Farxiga approved in the US for the treatment of paediatric type-2 diabetes astrazeneca.com ↗ |
| 2023-11-03 | AstraZeneca | Zibotentan/dapagliflozin combination demonstrated significant albuminuria reduction in patients with chronic kidney disease and proteinuria in ZENITH-CKD Phase IIb trial astrazeneca.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Forxiga | “1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg” NCT06560333 ↗10“treatment with an SGLT2 inhibitor (Forxiga, 10 mg tablet once daily)” NCT07143773 ↗ “Captopril, forxiga” NCT06417320 ↗ |
| Known as | Dapagliflozin | “All participants will take FORXIGA (Dapagliflozin) orally at a dose of 10mg/day for 12 weeks” NCT07225465 ↗ |
| Known as | Farxiga | “AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days” NCT04970940 ↗ |
| Action | Inhibit | “SGLT-2 inhibitors, including dapagliflozin) inhibit glucose reabsorption” NCT04049110 ↗ |
| Route | Oral | “Dose is titrated to 10 mg po daily or maximal tolerated dose” NCT02561130 ↗ |