Background:
Reperfusion therapies, including intravenous rt-PA and mechanical thrombectomy, significantly improve outcomes in acute ischemic stroke. However, these interventions also increase the risk of hemorrhagic transformation and malignant edema. Preclinical studies have demonstrated that Canagliflozin, an SGLT2 inhibitor, reduces astrocyte swelling and brain edema in a transient middle cerebral artery occlusion (tMCAo) model. While SGLT2 inhibitors have shown neuroprotective effects in the acute phase of ischemic stroke, their potential to mitigate hemorrhagic transformation and malignant edema following reperfusion therapy in humans remains unexamined.
Aims:
This study aims to evaluate the effect of SGLT2 inhibitors on hemorrhagic transformation and malignant edema in patients undergoing reperfusion therapy for acute ischemic stroke.
Methods:
This is a multi-center, randomized, open-label, controlled study enrolling ischemic stroke patients aged 18 years or older who meet predefined inclusion and exclusion criteria. Participants will be randomized to receive Canagliflozin 100 mg once daily for 14 days or no additional treatment before undergoing mechanical thrombectomy. Clinical data collection will include baseline demographics, medical and medication history, NIHSS scores at admission and 24 hours post-reperfusion, stroke subtype, modified Thrombolysis in Cerebral Infarction (TICI) scores, laboratory results, and modified Rankin Scale (mRS) scores at discharge and 3 months post-stroke.
The primary outcome is to assess the association between Canagliflozin use and the severity of hemorrhagic transformation and malignant edema. Hemorrhagic transformation will be classified using the Heidelberg criteria, and malignant edema will be defined as a midline shift of ≥5 mm. Brain imaging, including CT scans at 24 hours post-intervention and additional scans as clinically indicated, will be reviewed by blinded radiologists. Brain MRA will also be performed to assess infarct size and edema progression.
Importance:
This study aims to explore the potential for repurposing SGLT2 inhibitors as a therapeutic strategy in acute ischemic stroke. If Canagliflozin is shown to reduce hemorrhagic transformation and malignant edema, it could offer a novel adjunctive treatment to improve patient outcomes following reperfusion therapy.

Start Date01 Dec 2025

Sponsor / Collaborator

Taichung Veterans General Hospital

NCT06913647

/ Not yet recruitingPhase 2IIT

Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial

This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD.
The primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.

Start Date01 Sep 2025

Sponsor / Collaborator

Canadian Institutes of Health Research

NCT07076823

/ RecruitingPhase 1IIT

Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer: a Phase I Trial

Colorectal cancer (CRC), ranking third in incidence among men and second in women globally with third-highest mortality in the US, remains a major health challenge despite multimodal therapies, particularly for advanced-stage patients with poor prognosis where immune checkpoint inhibitors (ICIs) like PD-1/PD-L1 blockers have emerged as transformative agents by reinvigorating anti-tumor immunity through PD-1/PD-L1 pathway inhibition. While MSI-H CRC's high mutational burden renders it susceptible to immunotherapy, clinical trials demonstrate durable responses with domestic ICIs such as tislelizumab showing 41.2% ORR, 14.4-month PFS, and 28.7-month OS in metastatic MSI-H CRC, yet unmet needs persist. Intriguingly, SGLT-2 inhibitor exhibit promising oncolytic potential, particularly when combined with ICIs, as evidenced by observational studies revealing enhanced tumor control in pancreatic ductal adenocarcinoma through metabolic-immunologic crosstalk and our preclinical data showing synergistic CRC growth suppression with the SGLT-2 inhibitor canagliflozin plus PD-1 blockade. This phase II trial investigates the safety and efficacy of canagliflozin-tislelizumab combination in metastatic MSI-H CRC, evaluating its impact on PFS, OS, and ORR while dissecting tumor microenvironment modulation mechanisms, thereby pioneering a novel metabolic-immunotherapy paradigm that could redefine treatment paradigms through dual metabolic-immune regulation.

Start Date31 Jul 2025

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Canagliflozin Hemihydrate

100 Translational Medicine associated with Canagliflozin Hemihydrate

100 Patents (Medical) associated with Canagliflozin Hemihydrate

2,064

Literatures (Medical) associated with Canagliflozin Hemihydrate

01 Jan 2026·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR CELL RESEARCH

Canagliflozin inhibits p38MAPK signaling to protect tubular epithelial cell against pyroptosis in sepsis-induced acute kidney injury

Article

Author: Song, Li-Ge ; Liu, Gang ; Guo, Chun-Lin ; Zhu, Yun-Feng ; Bian, Rong-Xin ; Nie, Chun-Ying ; Wang, Jing

This paper aimed to investigate the impacts and mechanisms of canagliflozin (CANA) in sepsis-induced acute kidney injury (SAKI). SAKI models were established using HK2 cells treated with lipopolysaccharide (LPS) and mice received cecum ligation puncture (CLP) surgery. The pathological examination was applied to evaluate mouse kidney damage. Inflammatory cytokines were evaluated using ELISA and RT-qPCR assay. Flow cytometry and TUNEL staining were employed to check cell apoptosis. The expression of apoptosis-, inflammation-, pyroptosis-, and pathway-related proteins were assessed via western blot. In CLP-induced mouse SAKI model, CANA attenuated renal pathological injury, inflammation response, pyroptosis and inhibited the p38MAPK pathway, as evidenced by the decrease of serum Scr and BUN levels, cell apoptosis, IL-1β and IL-18 levels, as well as GSDMD-N, cleaved caspase-1, and p38MAPK expression. In HK2 cells treated with LPS, inflammation response, pyroptosis, and the p38MAPK pathway were inhibited by CANA. Moreover, overexpression of p38MAPK reversed CANAs' effects on apoptosis, inflammation response, and pyroptosis in HK2 cells. In SAKI, CANA inhibited the p38MAPK pathway, thereby reducing cell apoptosis, inflammation response, and pyroptosis, which ultimately alleviating disease progression.

31 Dec 2025·RENAL FAILURE

Canagliflozin ameliorates high-salt-induced renal injury and premature aging in male Dahl salt-sensitive rats, with associated changes in SIRT6/HIF-1α signaling

Article

Author: Ma, Sai ; Zhai, Jianlong ; Wang, Zhongli ; Zhang, Tingting ; Guo, Yifang ; Cao, Boce ; Zhang, Guorui ; Lu, Fan ; He, Lili ; Liang, Yi ; Wang, Qiuyan ; Zuo, Qingjuan

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) exhibit renoprotective effects in diabetic and nondiabetic patients; however, the underlying mechanism remains unclear. This study aimed to investigate the effects of canagliflozin (an SGLT2i) on salt-sensitive hypertensive kidneys. Male Dahl salt-sensitive rats were fed a high-salt (8%) diet and then orally administered canagliflozin 30 mg/kg/day or 0.5% hydroxypropyl methylcellulose solution for 12 weeks. Thus, a high-salt-induced model of hypertensive kidney injury with premature aging was established to evaluate the protective effects and related mechanisms of canagliflozin on hypertensive kidneys. Canagliflozin reduced blood pressure, the serum creatinine concentration, and urinary albumin excretion in high-salt rats. Hematoxylin and eosin, Masson, and senescence-associated β-galactosidase (staining were performed on rat kidneys, revealing that canagliflozin alleviated renal fibrosis and premature aging. Immunohistochemical analysis and protein detection demonstrated that canagliflozin increased the expression of silent information regulator 6 (SIRT6) in the kidney, inhibited the expression of the hypoxia-inducible factor-1 alpha (HIF-1α) protein and its target genes, and alleviated kidney damage and premature aging. In summary, canagliflozin ameliorates renal injury and premature aging in male Dahl salt-sensitive rats fed high salt with associated changes in SIRT6/HIF-1α signaling.

01 Dec 2025·American journal of medicine open

The Association of SGLT2i vs DPP4i on Fracture: A Cohort Study in Veterans with Diabetes

Article

Author: Hackstadt, Amber ; Griffin, Katherine ; Javid, Amir ; Hung, Adriana ; Snyder, Kathryn ; Roumie, Christianne L ; Greevy, Robert

Background:

Increased bone turnover is associated with use of SGLT2i. Patients with diabetes experience adverse effects on bone metabolism. Our aim was to evaluate if SGLT2i was associated with fractures vs DPP4i as add-on therapy to diabetes regimens.

Methods:

We assembled a retrospective cohort of Veterans with diabetes combining Veterans Administration, Medicare, and National Death Index databases. Using an active comparator new user design, patients starting on SGLT2i or DPP4i were followed from prescription fill until a fracture event, death, stopping medication, loss of follow-up, or study end. Fractures included: face/skull, spine, ribs, long bones, hand/feet/digits, or hip. Fractures were identified based on a validated algorithm with positive predictive value 91.3% (86.8, 94.4). Cox models compared the association of fractures between SGLT2i and DPP4i in a propensity score-weighted cohort that balanced 70+ covariates including comorbidities, vital signs, labs, vitamin D levels, smoking, and medications.

Results:

The unweighted sample included 115,124 SGLT2i episodes (104,086 Veterans; 94% empagliflozin; 4% canagliflozin; 2% dapagliflozin) and 213,095 DPP4i episodes (173,724 Veterans; 45% saxagliptin; 15% sitagliptin; 34% alogliptin; 6% Linagliptin). After propensity score calculation and matched weighting, the cohort included 76,072 SGLT2i and 75,833 DPP4i episodes. Median age was 69.3 years and diabetes duration 9.7 (6.1, 14.0) years. In the matched weighted analyses, there were 1431 and 1564 fractures among SGLT2i and DPP4i users, respectively. There were no clinical differences in fractures per 1000 person-years: 18.2 (17.4, 19.1) vs 19.8 (19.0, 20.6). The adjusted hazard ratio (adjusted hazard ratio 0.93 [0.87, 0.99]) excluded increased risk of fractures (adjusted hazard ratio > 1) in SGLT2i users.

Conclusions:

SGLT2i use as add-on treatment for diabetes was not associated with increased fracture outcomes compared to DPP4i.

News (Medical) associated with Canagliflozin Hemihydrate

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

25 Jul 2025

·endpoints.news

CHMP backs Lilly’s Alzheimer’s drug in certain patients, Gilead’s twice-yearly HIV prevention shot, among others

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) landed on a number of high-profile decisions this week, including changing course on Eli Lilly’s Alzheimer’s drug in certain patients and recommending Gilead’s twice-yearly HIV preventive approach. Overall, CHMP said Friday that it is endorsing the authorization of 13 new medicines. It also said that the European Commission should reject three drugs, including Sarepta’s troubled Duchenne drug Elevidys , which Roche is licensed to distribute in Europe. Lilly’s Alzheimer’s drug Kisunla initially received a negative opinion in March. At the time, CHMP noted the benefits of the drug did not outweigh the risks of patients developing bleedings and swellings of the brain called amyloid-related imaging abnormalities (ARIA), which can be fatal. Kisunla was approved in the US in July 2024. CHMP has now reversed its previously negative opinion on Kisunla after reviewing Lilly’s new dosing plan, which includes starting off with a lower dose and additional measures to reduce the risk of ARIAs. Regulators have been wary of approving drugs with risks of ARIAs, such as Eisai and Biogen’s Alzheimer’s drug Leqembi, which was also initially rejected by the EMA last July. Since then, Leqembi was approved by the EC in April this year, becoming the first of its kind to be approved in Europe. It secured FDA approval in January. CHMP also endorsed Gilead’s twice-yearly injectable lenacapavir to prevent HIV. Lenacapavir is currently approved in Europe as a treatment for adults with multidrug-resistant HIV-1 infection, and not as a preventive measure. In a landmark move, lenacapavir was approved as PrEP in the US last month under the brand name Yeztugo. The same preventive product would have a different name in the EU : Yeytuo. Elsewhere, the European regulators also gave a positive opinion for Pfizer and BioNTech’s LP.8.1-adapted monovalent Covid-19 vaccine for individuals aged six months and older. This comes after the EMA’s Emergency Task Force recommended in May that Covid-19 vaccines need to be updated to target the LP.8.1 strain. Pfizer and BioNTech have already started manufacturing their LP.8.1-adapted Covid-19 vaccine. As soon as the EC gives its approval, the companies will be ready to ship the vaccine, they said in a Friday release . CHMP also recommended the approval of the following products: The EU regulators suggested recommending the following label expansions: CHMP recommended rejecting TETEC Tissue Engineering Technologies’ autologous cartilage-derived articular chondrocytes called Jelrix, as well as Prilenia Therapeutics’ Huntington’s disease drug Nurzigma.

Drug ApprovalVaccine

27 Feb 2025

·firstwordpharma.com

Medicare spending on popular diabetes meds jumps over 350% in five years

Medicare Part D spending on leading diabetes medications has reached unprecedented levels, with expenditure skyrocketing from $7.7 billion in 2019 to $35.8 billion in 2023 — translating to a 364% increase over the five-year period, according to newly released data.Auditors from the US Department of Health and Human Services' Office of Inspector General (OIG) identified and analysed Medicare Part D data for 10 widely prescribed type 2 diabetes medications, comprising seven GLP-1s and three SGLT-2 inhibitors, across the US and five overseas territories between January 2019 and December 2023. The analysis looked at utilisation metrics and spending patterns, drawing comparisons with metformin as a baseline therapy. GLP-1s lead uptickDuring the audit period, Medicare Part D expenditure for selected drugs totalled $92.8 billion, with six medications exhibiting substantial spending increases, led by GLP-1 products. Spending on Novo Nordisk's Rybelsus (semaglutide) jumped from $366,000 in 2019 to approximately $1.7 billion by 2023 — a 2182% increase — whereas Ozempic (semaglutide) expenditures increased nearly 16-fold from $552 million to $9.2 billion over the same period, with the number of beneficiaries receiving the medication rising by 929%. Meanwhile, Eli Lilly's Mounjaro (tirzepatide) showed 1541% spending growth in just its second year of coverage.The OIG noted that given a number of the medicines are commonly used off-label for other conditions, notably obesity, their increased use warrants "further inquiry to determine whether…the associated drugs were utilised for medically accepted indications." Meanwhile, TD Cowen analyst Rick Weissenstein suggested that "the data brief may provide ammunition for HHS Secretary Robert Kennedy Jr. and others who see the surge in GLP-1 use as a symptom of 'overmedication' more generally in the US."In contrast, use and spending on Novo's Victoza (liraglutide), Johnson & Johnson's Invokana (canagliflozin), as well as AstraZeneca's Byetta (exenatide) and Bydureon (exenatide extended-release), declined from 2019 to 2023, likely due to the introduction of newer alternatives. In addition, metformin expenditure decreased by 5% from $661 million in 2019 to $628 million in 2023.Spending growth outpaces enrolmentAccording to the analysis, the growth of the selected medications significantly outpaced the 12% increase in Medicare Part D enrolment during the same timeframe, raising concerns about the long-term financial sustainability of the programme. The report suggests that even if spending grows at the minimum observed annual rate of 42% during the five-year period, it could exceed $102 billion for the 10 drugs in 2026. “This substantial increase could have a financial impact on the Medicare programme,” the auditors noted in the report, adding that these findings “may be beneficial to CMS and other policymakers when developing future programme guidance related to these drugs.”Both Ozempic and Rybelsus made it on to the expanded list of medicines selected for the second round of Medicare price negotiations, drawn up by the outgoing Biden administration last month.

100 Deals associated with Canagliflozin Hemihydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09592	Canagliflozin Hemihydrate	A10BK02	DB08907

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Type 2 diabetes mellitus with established diabetic nephropathy	Japan	Mitsubishi Tanabe Pharma Corp.	20 Jun 2022
Diabetic Nephropathies	United States	Janssen Pharmaceuticals, Inc.	27 Sep 2019
Diabetes Mellitus, Type 2	United States	Janssen Pharmaceuticals, Inc.	29 Mar 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 3	United States	Janssen Research & Development LLC	10 Mar 2020
Heart failure with normal ejection fraction	Phase 3	United States	Janssen Research & Development LLC	10 Mar 2020
Heart failure with reduced ejection fraction	Phase 3	United States	Janssen Research & Development LLC	10 Mar 2020
Cardiovascular Diseases	Phase 3	United States	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Argentina	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Australia	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Belgium	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Canada	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Colombia	Janssen Research & Development LLC	09 Dec 2009
Cardiovascular Diseases	Phase 3	Czechia	Janssen Research & Development LLC	09 Dec 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02065791 \| NCT03036150 \| NCT03594110 (CANVAS, Pubmed \| Clin J Am Soc Nephrol)	Phase 3	Chronic Kidney Diseases	4,401	Canagliflozin	kxyanhfkcn(ylbiktxjmk): HR = 0.88 (95.0% CI, 0.8 - 0.98), P-Value = 0.02 View more	Positive	01 Sep 2025
				Placebo
NCT01032629 (CANVAS, Pubmed \| Eur J Heart Fail)	Phase 3	-	5,281	Canagliflozin	ckjbfodnjj(gewmoldvqo): HR = 0.65 (95.0% CI, 0.53 - 0.79) View more	Positive	21 Jul 2025
				Placebo
NCT03170518 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	171	placebo+canagliflozin (Placebo)	zepgephnzo(ycppimicuz) = coalgyyeul rshnxhdsek (ilqsramvfj, 0.191) View more	-	12 Mar 2025
				Canagliflozin (Canagliflozin 100/300 mg)	zepgephnzo(ycppimicuz) = islyhyjqsd rshnxhdsek (ilqsramvfj, 0.194) View more
NCT03436693 (CTgov)	Phase 3	Diabetic Nephropathies	308	Canagliflozin (Canagliflozin 100mg)	fzvjlcsgll = wvfivcuezs znulnutzum (svzcgcpvup, aqkhhnxugg - owidjinanv) View more	-	15 Jul 2024
				Placebo (Placebo)	fzvjlcsgll = cbwqvmlofc znulnutzum (svzcgcpvup, nzesshfiah - xuawpjeiwk) View more
1340-P (ADA2024)	Not Applicable	Diabetes Mellitus	-	SGLT2i	wrgqenvclx(rcacrrkkly) = whbainsshf hlcgfhdkyp (jpxngcfyxv, 16.6 - 19.7)	Positive	14 Jun 2024
				DPP4i	wrgqenvclx(rcacrrkkly) = peksujewoq hlcgfhdkyp (jpxngcfyxv, 19.1 - 21.4)
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin 100 mg/d	ygxqzczeeg(uphnttalaw) = hfhhzyrcos mjqynvxidj (sdbioybrsc ) View more	-	14 Jun 2024
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS Program and CREDENCE trial, Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	eeallnhcrk(bjgjhzobqu): HR = 0.83 (95% CI, 0.75 - 0.93) View more	Positive	01 Dec 2023
				Placebo
NCT02065791 (CREDENCE, Pubmed \| Circulation)	Phase 3	Diabetic Nephropathies	2,627	Canagliflozin	orinzmewmj(dmkkcarlyx) = qmmniirwpz qyeadhxqlm (uyklmyyvvx ) View more	-	22 Aug 2023
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS and CREDENCE Trials, Pubmed)	Not Applicable	Diabetes Mellitus, Type 2 \| Cardiovascular Diseases \| Diabetic Nephropathies ... View more	-	Canagliflozin	xnunricfzx(nmisemqtby) = aiqgxiygcv mcwxpvzkzx (zwrybjgvec )	-	22 Jun 2023
CANVAS Program and CREDENCE trial (ESC2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	djayapvvdh(ghhegimtpz): HR = 0.74 (95% CI, 0.66 - 0.84), P-Value = Day 44 View more	-	20 May 2023
				Placebo

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