Delving into the Latest Updates on Canagliflozin Hemihydrate with Synapse

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

NCT06858436

/ Not yet recruitingPhase 4IIT

The Role of SGLT2 Inhibitors in Stroke-reperfusion Injury:A Multi-Center, Randomized, Open-Label, Controlled Trial

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 Date25 Jun 2025

Sponsor / Collaborator

Taichung Veterans General Hospital

NCT06851962

/ Not yet recruitingPhase 4IIT

Single-blinded, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes

The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are:
* Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile?
* What medical problems do participants experience while taking the treatment?
Participants will:
* Take the treatment described according to the Summary of Product Characteristics (SmPC).
* Visit the clinic once every 12 weeks for checkups and tests.
* Keep a diary of their symptoms to inform the Investigator.

Start Date01 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Canagliflozin Hemihydrate

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100 Translational Medicine associated with Canagliflozin Hemihydrate

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100 Patents (Medical) associated with Canagliflozin Hemihydrate

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2,531

Literatures (Medical) associated with Canagliflozin Hemihydrate

01 Jul 2025·HEART & LUNG

Immediate and short-term outcomes of in-hospital canagliflozin initiation in acute heart failure: Results from the CANA-AHF randomized clinical trial

Article

Author: Ali, Ahmed Ali ; Zarif, Bassem ; William, Mira Magdy ; Sabry, Nirmeen A ; Abbassi, Maggie M ; El-Gazar, Rabab A

BACKGROUND:

Early initiation of empagliflozin, a sodium-glucose cotransporter 2 inhibitor, in acute heart failure (AHF) patients increases urine output, reduces hospital stays, and enhances quality of life post-hospital discharge.

OBJECTIVES:

This trial aims to investigate the effectiveness and safety of early canagliflozin initiation compared to empagliflozin in hospitalized AHF patients with volume overload.

METHODS:

This was a multicenter, prospective, open-labeled, randomized equivalence trial. AHF diabetic and non-diabetic patients were randomized within 24 h from hospital admission to either receive 100 mg canagliflozin or 10 mg empagliflozin in addition to the standardized protocol for an intravenous loop diuretic. The primary outcome was the median of daily diuresis during the hospitalization period.

RESULTS:

Hospitalized AHF patients were enrolled (71 patients per group). The median daily diuresis during the hospitalization period was 4200 ml in the canagliflozin group, which was statistically equivalent to empagliflozin (4117 ml) with a difference of 83 ml, which falls within the predefined equivalence margin (±10) % of the median of daily diuresis of empagliflozin; Δ = ±411.7 mL), confirming equivalence via bootstrap TSOT p < 0.001. No difference was observed in diuretic response, dyspnea score, orthodema congestion score or length of hospital stay. The NT-proBNP level at day 30 post-discharge and the change in KCCQ-TSS from baseline to day 90 were statistically comparable between both groups, without differences in safety event incidence.

CONCLUSION:

Canagliflozin could be a part of usual care for hospitalized AHF patients and an alternative to empagliflozin without safety concerns.

01 Jun 2025·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

SGLT2i delays c-Myc-induced HCC progression via targeting mTOR

Article

Author: Du, Weixing ; Ke, Jing ; Liu, Zhixin ; Yu, Juan ; Qiu, Zhenpeng ; Qu, Xinyang ; An, Xiaotong ; Liu, Danwen ; Rao, Huiling ; Li, Wanrong ; Li, Shan ; You, Lei ; Xie, Jin ; Tian, Lin ; Jia, Jie

BACKGROUND:

Hepatocellular carcinoma (HCC) stands as a primary malignant liver tumor characterized by metabolic reprogramming. The oncogene c-Myc exerts substantial influence by driving the transcription of numerous genes. Empagliflozin (EMPA), a sodium-glucose cotransporter-2 inhibitor (SGLT2i), is widely used in the treatment of type 2 diabetes and has recently attracted attention for its potential anti-cancer effects. This study aims to unravel the complex interplay among c-Myc, EMPA, and the mammalian target of rapamycin (mTOR) in HCC development and progression.

METHODS:

HCC induction in mice utilized high-pressure hydrodynamic transfection of the c-Myc plasmid. QPCR and immunohistochemistry experiments were performed to detect the expression of SGLT2 in HCC tissues. In vivo experiments were conducted to corroborate the upregulation of SGLT2 following c-Myc transfection. In invo and vitro investigations were conducted to evaluate the anti-cancer effects of two SGLT2i: EMPA and canagliflozin (CANA). Network pharmacology, molecular docking analyses, CETSA experiments, and additional western blot experiments were used to reveal EMPA's interaction inhibition with mTOR.

RESULTS:

The study identified an increase in SGLT2 expression in HCC tissues as a result of c-Myc overexpression. In vitro experiments confirmed the upregulation of SGLT2 following c-Myc transfection. Notably, the administration of SGLT2i effectively curtailed liver cancer progression, and reduced hepatic fat accumulation in mice. EMPA exhibited significant suppression of cell proliferation in c-Myc-transfected cells. In vitro experiments unveiled EMPA's interaction and with inhibition the activation of mTOR.

CONCLUSION:

Our study highlights EMPA's potential as a therapeutic agent in delaying the development and progression of HCC.

24 May 2025·Journal of biomolecular structure & dynamics

Identification of approved drugs with ALDH1A1 inhibitory potential aimed at enhancing chemotherapy sensitivity in cancer cells: an in-silico drug repurposing approach

Article

Author: Paul, Sanjay Kumar ; Guendouzi, Abdelmadjid ; Banerjee, Agniswar ; Guendouzi, Abdelkrim ; Haldar, Rajen

The aldehyde dehydrogenase 1A1 (ALDH1A1) also known as retinal dehydrogenase, is an enzyme normally involved in the cellular metabolism, development and detoxification processes in healthy cells. However, it's also considered a cancer stem cell marker and its high levels of expression in several cancers, including breast, lung, ovarian, and colon cancer have been associated with poor prognosis and resistance to chemotherapy. Given its crucial role in chemotherapy resistance by detoxification of chemotherapeutic drugs, ALDH1A1 has attracted significant research interest as a potential therapeutic target for cancer. Though a few synthetic inhibitors of ALDH1A1 have been synthesized and their efficacy has been proved in-vitro and in-vivo studies, none of them have passed clinical trials so far. In this scenario, we have performed an in-silico study to verify whether any of the already approved drugs used for various purposes has the ability to inhibit catalytic activity of ALDH1A1, so that they can be repurposed for cancer therapy. Keeping in mind the feasibility of repurposing in a larger population we have selected the approved drugs from five widely used drug categories such as antibiotic, antiviral, antifungal, anti diabetic and antihypertensive for screening. Computational techniques like molecular docking, molecular dynamics simulations and MM-PBSA binding energy calculation have been used in this study to screen the approved drugs. Based on the logical analysis of results, we propose that three drugs - telmisartan, irbesartan and maraviroc can inhibit the catalytic activity of ALDH1A1 and thus can be repurposed to increase chemotherapy sensitivity in cancer cells.

38

News (Medical) associated with Canagliflozin Hemihydrate

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.

26 Feb 2025

·endpts.com

Medicare spending on common diabetes drugs skyrocketed, HHS inspector general finds

The use of a subset of common diabetes drugs skyrocketed in the US Medicare program over a five-year period ending in 2023, according to a new report from the HHS inspector general. The report looked at two widely used classes of diabetes drugs: GLP-1s like Novo Nordisk’s Ozempic, and SGLT-2 drugs including Johnson & Johnson’s Invokana. It found huge growth in the GLP-1 class, with the number of Medicare patients on Ozempic and Rybelsus, another GLP-1 from Novo, rising more than 900% each over that period. The analysis also looked at spending on the products — but with some limitations. Upfront Part D spending on the drugs in 2023 totaled $35.8 billion, with Novo Nordisk’s flagship product Ozempic accounting for more than a quarter of that. But the total is based on list prices and doesn’t include the significant rebates paid by drugmakers, which if included would likely slash the reported amounts. While the number of prescribers of these drugs has grown considerably, who is prescribing the drugs has changed, too. “The prescribers of the diabetes drugs came from a broad range of specialties, primarily internal medicine and endocrinologists, but also including dentists, optometrists, chiropractors, and acupuncturists,” the report found. The agency inspector general projected that if the rate of utilization and spending continues at a similar pace, then annual spending on the same 10 drugs could eclipse $100 billion by 2026, based on list prices and not including rebates. Analysts at TD Cowen said in an investor note Tuesday that the auditing of the drugs was a “minor fundamental risk to GLP-1 uptake.” If anything, they said, it may throw more cold water on an already sluggish effort to expand Medicare’s coverage to include some patients with obesity. “Probably the greatest concern for Novo and Lilly should come in the signal that this report sends as it relates to the government’s cost concerns and its broader stance toward GLP-1s,” the note said.

31 Aug 2024

·www.pharmaceutical-technology.com

Diabetes duration has minimal impact on SGLT2 inhibitor efficacy, as per new analysis

Dr. Jawad Haider Butt shared data demonstrating that a patient’s duration of living with type 2 diabetes does not impact treatment response to Forxiga. Credit: Photo Nature Travel via Shutterstock. SGLT2 inhibitors show significant promise in the treatment of heart failure regardless of how long a patient has had type 2 diabetes, as per a new meta-analysis presented at the European Society of Cardiology (ESC) Congress. At the ESC congress, held from 30 August to 2 September, Dr. Jawad Haider Butt, a research fellow at the University of Glasgow’s British Health Foundation Cardiovascular Research Centre, presented data surrounding the use of SGLT2 inhibitors in patients with heart failure and type 2 diabetes. Despite an industry conception that patients with long-standing type-2 diabetes may be less likely to tolerate and benefit from new treatments, a pooled meta-analysis of AstraZeneca ’s DAPA-HF Phase III trial (NCT03036124) and the Phase III DELIVER trial (NCT03619213), investigating Forxiga (dapagliflozin propanediol), showed that the benefit of Forxiga or Farxiga on the primary outcome was consistent across patients with different type 2 diabetes durations. Furthermore, treatment with Forxiga had a consistent benefit on the worsening of heart failure across type 2 diabetes patients. The pairing of type 2 diabetes and heart failure can be fairly common in patients, explained Butt. Several companies pursue drug development in the two indications due to their overlapping pathogenesis. For example, in 2014, the US Food and Drug Administration first approved Forxiga for the treatment of type 2 diabetes. AstraZeneca has since received approvals for the drug in other metabolic indications, like heart failure with reduced ejection fraction in 2020. Other SGLT2 inhibitor drugs such as Johnson and Johnson’s Invokana (canagliflozin) and Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) are also marketed for the treatment of heart failure and type 2 diabetes in the US. The class of drugs has made a major impact on the heart failure treatment landscape in recent years, amassing significant sales for each company. See Also: J&J targets generalised myasthenia gravis landscape with nipocalimab Pancreatic Islet Transplant Rejection drugs in development, 2024 In a Q2 financial report, Eli Lilly shared that its US revenue from Jardiance reached $428.9m during the quarter. Furthermore, a 2023 annual financial report labelled Forxiga as AstraZeneca’s best-selling drug that year, making $5.96bn in global sales.

Drug ApprovalPhase 3Financial StatementClinical Result

100 Deals associated with Canagliflozin Hemihydrate

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KEGG	Wiki	ATC	Drug Bank
D09592	Canagliflozin Hemihydrate	A10BK02	DB08907

R&D Status

Approved

10 top approved records.

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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.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03170518 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	171	placebo+canagliflozin (Placebo)	zbeelsahqy(sqqpgivnqg) = skvokcjspt lhgjxaznpg (fqbiovmsuc, 0.191) View more	-	12 Mar 2025
				Canagliflozin (Canagliflozin 100/300 mg)	zbeelsahqy(sqqpgivnqg) = uictdwamjd lhgjxaznpg (fqbiovmsuc, 0.194) View more
NCT03436693 (CTgov)	Phase 3	Diabetic Nephropathies	308	Canagliflozin (Canagliflozin 100mg)	ueppxtaecd = yykcyiiozm cxvaduebpv (cggrtxjkmk, vaajmpocwk - lshhzoxfeb) View more	-	15 Jul 2024
				Placebo (Placebo)	ueppxtaecd = chsvrfppne cxvaduebpv (cggrtxjkmk, dkdnqkskoc - ytisdkykfn) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin 100 mg/d	umqjcpqlew(smwtnjejkk) = hruwhxroos mhdbifmtho (oqhckvksqd ) View more	-	14 Jun 2024
1340-P (ADA2024)	Not Applicable	Diabetes Mellitus	-	SGLT2i	qfubduilrh(ftmypgwhxh) = qhotrsoyal dlilebknha (kgbkeptvjd, 16.6 - 19.7)	Positive	14 Jun 2024
				DPP4i	qfubduilrh(ftmypgwhxh) = moiueebyzx dlilebknha (kgbkeptvjd, 19.1 - 21.4)
Pubmed \| J Clin Endocrinol Metab	Not Applicable	Vitamin D Deficiency	-	Vitamin D3 supplementation	sfuuehtqxy(eifaqyclyf) = VitD3 supplementation decreased the magnitude of canagliflozin-induced changes in 1,25(OH)2D (from −31.3%±4.7% to −9.3%±8.3%; P = .04) jgitltuoxi (rqdtkxsuws ) View more	-	18 Jan 2024
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS Program and CREDENCE trial, Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	uivmbkqffk(ebfcjndujm): 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	mzbsjlcpmm(bwbyvrhqbk) = afvvenxfwu wtvliuwulc (zwgzpvrfmo ) View more	-	22 Aug 2023
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS and CREDENCE Trials, Pubmed)	Not Applicable	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Proteinuria ... View more	-	Canagliflozin	jzjvlweorn(kccrgqdiiq) = boixcvevrf sgkdmmrsbc (fuoiaaqkfw )	-	22 Jun 2023
ADA2023	Not Applicable	Diabetes Mellitus, Type 2	317	Canagliflozin 100 mg/d	awhpyveefy(qvuyvgsxhh) = mtrsyvzokb hjrexvqtaf (awyruaxmej ) View more	Positive	20 Jun 2023
				Canagliflozin 300 mg/d	awhpyveefy(qvuyvgsxhh) = mtjaltziay hjrexvqtaf (awyruaxmej ) View more
ADA2023	Not Applicable	Diabetes Mellitus	121	Canagliflozin	wvkthymcqx(ibgprmntza) = ueiwpiwzki bqcpkjhkpl (eccgmiatww )	Positive	20 Jun 2023
				Canagliflozin (Low-Carbohydrate Diet)	wvkthymcqx(ibgprmntza) = eshgkfpbrq bqcpkjhkpl (eccgmiatww )