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Drug

Canagliflozin

Approved · FDA / EMA
Emerging researchLate-stage developmentSteady momentum

Also known as Invokamet, Invokana, Canagliflozina.

5
Research papers
11
Active clinical trials
29
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease

Clinical trial2026-06-02Results expected Q4 2026 · ClinicalTrials.gov

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes
83%High confidence
Uncertainty ±8%Evidence coverage: SubstantialUpdated 30 June 2026

Confidence is high because multiple independent trials consistently report HbA1c, with a narrow uncertainty band; publication incorporation remains limited.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Canagliflozin
Aliases & brands
InvokametInvokanaCanagliflozina
RxNorm CUI
1373458
ChEMBL ID
CHEMBL2103841
UNII
0SAC974Z85
Regulatory jurisdictions
emamhrafda

Regulatory timeline

29 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2013-03-292014-06-05)
Earliest approval
2013-03-29
Latest approval
2024-12-18
Authorities
FDA · EMA · MHRA
Total events
29
fdaU.S. Food and Drug Administration· 27 events
2026-06-03Label change
Label change: CANAGLIFLOZIN (NDA204042)
Evidence ↗
2024-12-18Indication expansion
Indication expansion: CANAGLIFLOZIN (NDA204042)
Evidence ↗
2024-08-23Label change
Label change: CANAGLIFLOZIN (NDA204042)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2013-11-15ApprovalMulti-authority
Approval: Invokana (EMA)
Indication: Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet andShow full indication

Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:  as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2016-06-15Safety communicationSafety
Drug Safety Update: Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

105 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
105
registered trials across all phases
LATEST COMPLETION 2024
11
Active studies
7
Recruiting
52
Late-stage (III+)
79
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 105
Phase 142Phase 1 / 21Phase 210Phase 2 / 31Phase 320Phase 424Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20172024
Most influential
Recent papers
Major research themes5
Diabetes Mellitus, Type 22Renal Insufficiency, Chronic2Sodium-Glucose Transporter 2 Inhibitors2Cardiovascular Diseases1Diabetic Nephropathies1
Journals, researchers & institutions
Top journals
  • Diabetes, obesity & metabolism2
  • Cardiovascular diabetology1
  • Circulation1
  • Journal of diabetes investigation1
Leading researchers
  • Gouda M2
  • Iijima H2
  • Inagaki N2
  • Kadowaki T2
  • Kaneko G2
  • Kondo K2
  • Maruyama N2
  • Nakanishi N2
Leading institutions
free-text, unnormalised
  • Graduate School of Medicine2
  • Brigham and Women's Hospital1
  • Department of Clinical Pharmacy and Pharmacology1
  • Department of Nephrology and Laboratory Medicine1
  • Imperial College London1
  • Indiana University School of Medicine and VA Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.