Drugs / Xigduo
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Xigduo | — | 2014-01-16 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06327815 | Mar 2024 → Jun 2025 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-06-27 | AstraZeneca | Regulatory Xigduo XR approved in China for adults with type-2 diabetes astrazeneca.com ↗ |
| 2014-10-30 | AstraZeneca | Regulatory US FDA approves once-daily XIGDUO™ XR tablets for adults with Type 2 Diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. |
| 2014-01-21 | AstraZeneca | Regulatory XIGDUO™ (dapagliflozin and metformin hydrochloride) approved in the European Union for type 2 diabetes astrazeneca.com ↗
Tuesday, 21 January 2014 AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorisation by the European Commission for the treatment of type 2 diabetes in the European Union (EU). |
| 2013-11-22 | AstraZeneca | Regulatory Xigduo™ (dapagliflozin and metformin hydrochloride) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes astrazeneca.com ↗
The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-27 | AstraZeneca | Xigduo XR approved in China for adults with type-2 diabetes astrazeneca.com ↗ |
| 2014-10-30 | AstraZeneca | US FDA approves once-daily XIGDUO™ XR tablets for adults with Type 2 Diabetes astrazeneca.com ↗ |
| 2014-01-21 | AstraZeneca | XIGDUO™ (dapagliflozin and metformin hydrochloride) approved in the European Union for type 2 diabetes astrazeneca.com ↗ |
| 2013-11-22 | AstraZeneca | Xigduo™ (dapagliflozin and metformin hydrochloride) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes astrazeneca.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xigduo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06327815 ↗ |