Canagliflozin

For type 2 diabetes mellitus. Sold as Invokana. Every FDA application for this active ingredient: 1 branded and 6 generic.

As of Nov 15, 2026, FDA lists 7 applications for Canagliflozin (sold as Invokana), first approved Mar 29, 2013, with 7 new uses approved and 0 published complete response letters.

First approved: Mar 29, 2013
Applications: 7
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $181M
First approved in the EU: Nov 15, 2013
First approved in Japan: Jul 4, 2014

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Invokana	Part D	$181M	-34%	38,834

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

INVOKANA 100 MG TABLET: $19.10 per unitBrand · 0% in a year
INVOKANA 300 MG TABLET: $19.12 per unitBrand · 0% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)Aug 26, 2020 · boxed warning

Approvals in the EU (EMA)

First approved in the EU 8 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Invokana, new substanceJanssen-Cilag International NV · Nov 15, 2013

Approvals in Japan (PMDA)

First approved in Japan 15 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

CanagluA drug with a new indication for the treatment of chronic kidney disease associated with type 2 diabetes mellitus (excluding patients who have end-stage… · Mitsubishi Tanabe Pharma Corporation · Jun 20, 2022
Canaglu, new ingredientA drug with a new active ingredient indicated for the treatment of type 2 diabetes mellitus. · Mitsubishi Tanabe Pharma Corporation · Jul 4, 2014

Clinical Trials

25 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney DiseaseDiabetic Kidney Disease (DKD), Type 2 Diabetes · Beijing University of Chinese Medicine	Phase 2	Active, not recruiting	Oct 30, 2026
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial CancerEndometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia · Wang Yingmei	Phase 2	Not yet recruiting	Oct 22, 2026
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive ImpairmentType 2 Diabetes Mellitus, Cognitive Impairment · Fudan University	Phase 4	Recruiting	Jul 17, 2026
Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid CancerSolid Tumor, SGLT 2 Inhibitors · West China Hospital	Phase 1	Recruiting	Jul 14, 2026
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Chronic Kidney Disease, Type 2 Diabetes · Baylor Research Institute	Phase 4	Enrolling by invitation	Apr 23, 2026
CANagliflozin In DIALysis PatientsDialysis, Chronic Kidney Disease (Stages 4 and 5) · University Medical Center Groningen	Phase 4	Not yet recruiting	Apr 14, 2026
Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.Chronic Kidney Diseases, MAFLD · Institute of Liver and Biliary Sciences, India	Not applicable	Recruiting	Feb 5, 2026
Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor AgonistsType 2 Diabetes (T2DM) · MaryAnn Banerji	Phase 4	Active, not recruiting	Jan 8, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 29, 2013	InvokanaNDA 204042 · New molecular entity	Janssen Pharms	26	Marketed
Apr 14, 2026	CanagliflozinANDA 210449	Apotex	0	Marketed
Apr 20, 2026	CanagliflozinANDA 210386	Aurobindo Pharma Ltd	0	Discontinued
—	CanagliflozinANDA 210297	Sandoz Inc	0	Discontinued
—	CanagliflozinANDA 210451	Teva Pharms USA	0	Discontinued
—	CanagliflozinANDA 210503	Laurus Labs Ltd	0	Discontinued
—	CanagliflozinANDA 210541	Zydus Pharms USA Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA