Wednesday, July 8, 2026

Drug profile · INN

dapagliflozin

dapagliflozin (FORXIGA) is a sodium/glucose cotransporter 2 inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Alimentary tract and metabolism (A10) A10BK01
US status approved
Patents linked 1
Pipeline programs 52
News articles 1
Drug details — dapagliflozin
US status
approved
Class
Alimentary tract and metabolism (A10)
Route
ORAL
Patents
1
Programs
52
Data quality
0.89

Quick answer

dapagliflozin (FORXIGA) is a sodium/glucose cotransporter 2 inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dapagliflozin
Brand FORXIGA
Mechanism Sodium/glucose cotransporter 2 inhibitor
Target Sodium/glucose cotransporter 2
Therapeutic class Alimentary tract and metabolism (A10)
Route ORAL
Formulation TABLET, EXTENDED RELEASE
ATC code A10BK01
Originator AstraZeneca

Mechanism of action

Sodium/glucose cotransporter 2 inhibitor

Primary target: Sodium/glucose cotransporter 2

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Recent coverage

Pipeline programs

  1. 021IGAN17001 Phase 3 · Travere Therapeutics · Immunoglobulin A Nephropathy (IgAN)
  2. 202100617 Phase 3 · Disc Medicine · Combined endpoint of all-cause mortality, kidney failure, an
  3. ANDA219975 + ANDA220011 Phase 3 · Lxo Ireland Designated · Type 2 Diabetes
  4. APHP220826 Phase 3 · PARItec · Adult patients discharged alive from ICU with a decreased eG
  5. APHP230833 Phase 3 · PARItec · Heart failure
  6. D4325C00010 Phase 3 · AstraZeneca · Chronic Kidney Disease and High Proteinuria
  7. D6402C00012 Phase 3 · AstraZeneca · Heart Failure and Impaired Kidney Function
  8. D6402C00012 Phase 3 · AstraZeneca · Chronic HF and comorbid impairment of kidney function who ha

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. US 20260097057

    COMBINATION OF ZIBOTENTAN AND DAPAGLIFLOZIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE AND LIVER FIBROSIS

    Expires Wed Apr 04 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dapagliflozin?

dapagliflozin (FORXIGA) is a sodium/glucose cotransporter 2 inhibitor. Associated with AstraZeneca. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dapagliflozin?

FORXIGA is a marketed brand name for dapagliflozin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dapagliflozin?

dapagliflozin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.