Friday, July 10, 2026

Drug profile · INN

dapagliflozin + metformin

dapagliflozin + metformin (XIGDUO XR 5/1000) is an FDA-listed pharmaceutical active ingredient. Associated with AstraZeneca.

TGA: approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — dapagliflozin + metformin

Quick answer

dapagliflozin + metformin (XIGDUO XR 5/1000) is an FDA-listed pharmaceutical active ingredient. Associated with AstraZeneca.

Key facts

INN dapagliflozin + metformin
Brand XIGDUO XR 5/1000
Originator AstraZeneca

Approval history

Authority Status Date
TGA approved

Pipeline programs

  1. 1019/25 Phase 1 · Tillomed Laboratories · Bioavailability study in healthy volunteers under fed condit
  2. Bioequivalence clinical trial of two formulations of dapagliflozin/metformin Phase 1 · Tillomed Laboratories · Healthy volunteers
  3. Bioequivalence clinical trial of two formulations of dapagliflozin/metformin Phase 1 · Tillomed Laboratories · Healthy volunteers

Frequently asked questions

What is dapagliflozin + metformin?

dapagliflozin + metformin (XIGDUO XR 5/1000) is an FDA-listed pharmaceutical active ingredient. Associated with AstraZeneca.

What is the brand name for dapagliflozin + metformin?

XIGDUO XR 5/1000 is a marketed brand name for dapagliflozin + metformin. Check FDA Drugs@FDA for the current US label holder and prescribing information.