Study on the impact of Canagliflozin combined with chemotherapy on the outcomes of patients with pulmonary tuberculosis and diabetes mellitus comorbidity

Start Date15 Feb 2026

Sponsor / Collaborator-

CTIS2025-522742-46-00

/ Not yet recruitingPhase 4

CANIDIAP; CANagliflozin In DIAlysis Patients

Start Date01 Feb 2026

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

CTIS2025-523375-29-00

/ Not yet recruitingPhase 3

Sodium-glucose cotransporter-2 inhibitors to stABiLizE coronary atherosclerosis pro-gression after acute Myocardial Infarction in women and men with diabetes mellitus

Start Date31 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Canagliflozin Hemihydrate

100 Translational Medicine associated with Canagliflozin Hemihydrate

100 Patents (Medical) associated with Canagliflozin Hemihydrate

1,920

Literatures (Medical) associated with Canagliflozin Hemihydrate

01 Apr 2026·CURRENT PROBLEMS IN CARDIOLOGY

NRF2-mediated anti-ferroptotic pathways in diabetic cardiomyopathy: Mechanistic insights, therapeutic advances, and challenges in cardiovascular protection

Review

Author: Al-Doaiss, Amin A ; Halawi, Mustafa H ; Thornbury, William ; Almehmadi, Mazen ; Khan, Shahid Ullah ; Alsyaad, Khalid M ; Ahmed, Ahmed Ezzat ; Ibrahim, Essam H ; Taha, Ramadan

Diabetic cardiomyopathy (DCM) remains a major contributor to cardiovascular morbidity and mortality, yet its underlying mechanisms extend beyond hyperglycemia-induced metabolic stress. Emerging evidence identifies ferroptosis, a regulated, iron-dependent lipid peroxidation process, as a central driver of diabetic myocardial injury. This review synthesizes molecular insights demonstrating how chronic hyperglycemia, oxidative stress, and mitochondrial dysfunction create a uniquely ferroptosis-prone cardiac environment. Particular emphasis is placed on the NRF2 signaling network, which orchestrates antioxidant defense through the HO-1 pathway and the SLC7A11-GSH-GPX4 axis. Diabetic impairment of AMPK/AKT-dependent NRF2 activation compromises these protective systems, accelerating lipid peroxidation, mitochondrial damage, inflammation, and cardiomyocyte death. We further evaluate emerging pharmacologic and natural NRF2 activators, including sulforaphane, curcumin, dexmedetomidine, canagliflozin, and 6-gingerol, demonstrating consistent cardioprotective, anti-ferroptotic benefits in preclinical models. Despite encouraging progress, concerns regarding long-term NRF2 overstimulation, metabolic reprogramming, and oncogenic risk underscore the need for carefully optimized therapeutic strategies. By integrating mechanistic advances with translational challenges, this review highlights NRF2-ferroptosis modulation as a promising frontier for targeted DCM therapy and future precision cardiology.

01 Feb 2026·BIOCHEMICAL PHARMACOLOGY

The sodium-glucose cotransporter-2 inhibitor canagliflozin alleviates endothelial dysfunction in a rat bypass model

Article

Author: Korkmaz-Icöz, Sevil ; Karck, Matthias ; Lian, Shuo ; Kraft, Patricia ; Ma, Ming ; Szabó, Gábor ; Sayour, Alex Ali ; Mayer, Tobias

Ischemia/reperfusion (IR) injury during coronary artery bypass grafting surgery has detrimental impacts on endothelial integrity and function. Studies have suggested that canagliflozin (CANA) mitigates the risk of cardiovascular events, independently of diabetes. We hypothesized that the supplementation and/or administration of CANA protects vascular grafts in a bypass model in non-diabetic Lewis rats. The aortic arches of control rats (n = 9) were harvested, aortic rings were prepared, then mounted in organ baths. In the IR and IR + CANA_suppl groups (n = 8/group), aortic arches were preserved in either saline or CANA-supplemented saline (5 µM) for 1 h at 4 °C before transplantation. In the IR + CANA_inject and IR + CANA_suppl+inject groups (n = 9/group), aortic arches were preserved in cold saline or CANA for 1 h and recipients received CANA (10 µg/kg, intravenous) 5 min prior to reperfusion. After 1 h of in vivo blood reperfusion, ex vivo vascular function was assessed and immunohistochemistry was performed. The decreased maximum relaxation (R_max) to acetylcholine in the IR group compared to controls (20 ± 3 % vs 83 ± 2 %, p < 0.05) was improved in both the IR + CANA_inject (36 ± 2 % vs. 20 ± 3 %, p < 0.05) and IR + CANA_suppl+inject (45 ± 3 % vs. 20 ± 3 %, p < 0.05) groups. Additionally, the IR + CANA_suppl+inject rings exhibited a further increased R_max to acetylcholine compared to both the IR + CANA_suppl (45 ± 3 % vs. 31 ± 2 %, p < 0.05) and IR + CANA_inject (45 ± 3 % vs. 36 ± 2 %, p < 0.05) groups. Increased DNA strand breaks in the IR group compared to controls were decreased in all CANA groups. The reduced immunoreactivity of CD-31 was ameliorated in the IR + CANA_inject and IR + CANA_suppl+inject groups. CANA alleviates endothelial dysfunction induced by IR injury in a rodent model of revascularization.

01 Feb 2026·PHARMACOTHERAPY

Circulating Profiles of the Bile Acid Metabolomics in Patients With Polycystic Ovary Syndrome Treated With Metformin or Canagliflozin

Article

Author: Qi Yan ; Jing Luo ; Hua Zhang ; Nan Wang ; Yikun Zhu ; Meili Cai ; Jin Li ; Wenhao Wu ; Manna Zhang

ABSTRACT:

Objective:

Bile acids are indispensable modulators in the development of polycystic ovary syndrome (PCOS). Our previous study identified that metformin and canagliflozin have similar efficacy in patients with PCOS combined with insulin resistance (IR). However, the effect of metformin or canagliflozin on bile acid metabolism in patients with PCOS has not been elucidated. The objective of this study was to use targeted metabolomics technology to compare alterations of circulating bile acid metabolites in patients with PCOS before and after treatment with metformin or canagliflozin.

Design and Patients:

This study was a subanalysis of a previous randomized open‐label study, in which patients with PCOS combined with IR were enrolled and treated with either metformin ( n = 35) or canagliflozin ( n = 33) for 12 weeks.

Measurements:

The serum bile acid profile was measured using high‐performance liquid chromatography–tandem mass spectrometry (LC–MS/MS). The differences in serum bile acid metabolites in patients with PCOS before and after treatment were analyzed. In addition, the correlation between bile acid metabolites and PCOS‐related clinical characteristics was evaluated.

Results:

There were no significant differences in serum bile acid metabolites in patients with PCOS before and after canagliflozin treatment. Metformin treatment substantially decreased serum total bile acid levels in patients with PCOS, especially primary conjugated bile acids. The levels of taurochenodeoxycholic acid (TCDCA), glycocholic acid (GCA), and glycochenodeoxycholic acid (GCDCA) showed significant differences from baseline in the serum of patients with PCOS after treatment with metformin. Correlation analysis showed that alterations of GCA, TCDCA, and GCDCA were associated with changes in multiple clinical parameters of patients with PCOS treated with metformin.

Conclusion:

The effects of metformin and canagliflozin on bile acids metabolism in patients with PCOS are different. The beneficial effects of metformin on PCOS may be related to the changes in bile acid metabolites.

Trial Registration:

ClinicalTrials.gov : NCT04700839

News (Medical) associated with Canagliflozin Hemihydrate

18 Nov 2025

·www.drugs.com

American Society of Nephrology, Nov. 5-9

The annual meeting of the American Society of Nephrology (Kidney Week) was held this year from Nov. 5 to 9 in Houston, attracting attendees from around the world, including nephrology specialists, researchers, scientists, and other health care professionals. The conference featured presentations focusing on the latest advances in the management of patients with kidney diseases and related disorders. In one study, Daniel Gale, Ph.D., of University College London, and colleagues showed that an NADPH oxidase synthase (NOX) 1/4 inhibitor, setanaxib, has an acceptable safety profile, with some evidence of reduced proteinuria among patients with Alport syndrome. The researchers analyzed the safety and efficacy of setanaxib in Alport syndrome. In a 2:1 randomized controlled trial of 20 patients, 24 weeks of treatment was well tolerated, and there was some evidence of reduced proteinuria in the treatment group compared with placebo. The study was a small phase 2a exploratory study and none of the differences observed were statistically significant. "We conclude that these results justify a further (larger and longer) randomized controlled study to quantify the safety and efficacy of this drug to treat people with Alport syndrome," Gale said. The study was funded by Calliditas Therapeutics, which is developing setanaxib. Abstract No. SA-OR082 In another study, Charmaine E. Lok, M.D., of the University Health Network in Toronto, and colleagues found that daily oral supplementation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the form of fish oil is safe and reduces the rate of serious cardiovascular events in patients with kidney failure on maintenance hemodialysis. As part of the PISCES study, 1,228 patients who were treated with chronic hemodialysis were randomly assigned to oral daily fish oil or placebo capsules. The investigators found that the rate of serious cardiovascular events (heart attack, stroke, peripheral vascular disease leading to amputation, and cardiac death) was reduced by approximately 40 percent in patients treated with maintenance hemodialysis who received daily oral supplementation of 4 g of fish oil (total EPA, 1.6 g; total DHA, 0.8 g) compared with placebo. The rate of serious cardiovascular events was 0.31/1,000 days in the fish oil group versus 0.61/1,000 days in the placebo group. Adverse events, including bleeding, did not differ between the groups. "Given the underlying high risk of cardiovascular events, lack of other preventative measures, and safety of fish oil, I would not be surprised if there is quick uptake of fish oil supplementation in patients receiving hemodialysis," Lok said. "It should be emphasized that the dose and formulation of fish oil, and how it is taken, is important." Abstract No. FR-OR082 Natalie Staplin, Ph.D., of the University of Oxford Medical Sciences Division in the United Kingdom, and colleagues demonstrated clear absolute benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors on kidney, hospitalization, and mortality outcomes irrespective of diabetes status and level of urine albumin-to-creatinine ratio. The authors conducted a meta-analysis of 58,816 participants enrolled in eight large randomized trials of SGLT2 inhibitors, including empagliflozin, dapagliflozin, and canagliflozin, compared with placebo. The investigators found that SGLT2 inhibitors substantially reduced the risks for kidney disease progression, acute kidney injury, hospitalization, and death among individuals with and without diabetes and across all levels of albuminuria. Compared with placebo, allocation to SGLT2 inhibition reduced the hazard of kidney disease progression by 35 percent among participants with diabetes and 26 percent among participants without diabetes. Allocation to SGLT2 inhibition reduced the risk for acute kidney injury to a similar extent in participants with and without diabetes by 23 and 28 percent, respectively. The risk for hospitalization for heart failure was 32 and 25 percent lower in people with and without diabetes, respectively, who were allocated to an SGLT2 inhibitor, and the risk for any hospitalization was reduced by 10 and 11 percent, respectively. People with lower albumin levels, who are often at lower risk for kidney failure, experienced benefit as a result of taking an SGLT2 inhibitor, particularly through reduced hospital admissions for heart failure and any other cause. Participants with higher albuminuria (≥200 mg/g) had larger absolute reductions in kidney disease progression. "The findings suggest that guideline recommendations distinguishing between patients based on diabetes status or albuminuria level may no longer be necessary," Staplin said. "Current international kidney disease guidelines give stronger recommendations for using SGLT2 inhibitors in patients with high albumin levels, but the new results indicate that all patients with chronic kidney disease can benefit." Abstract No. FR-OR086 In the multicenter, randomized OPTIMIZE trial, Stefan P. Berger, Ph.D., of the Universitair Medisch Centrum Groningen in the Netherlands, and colleagues found that a reduced-dose immunosuppressive regimen combining low-dose tacrolimus plus everolimus is safe among older kidney transplant recipients (age 65 years and older), but the regimen does not lead to improved outcomes compared with the current standard regimen. The authors investigated whether older kidney transplant recipients could benefit from a reduced and less nephrotoxic immunosuppressive regimen. Three hundred seventy-nine kidney transplant recipients aged 65 years or older, across six Dutch university medical centers and the University Hospitals Leuven, were included in the study. The study compared a "standard" immunosuppressive regimen (prednisolone + standard-dose tacrolimus + mycophenolate mofetil) versus an "adapted" regimen (prednisolone + low-dose tacrolimus + everolimus). The primary outcome was defined as a "successful transplantation" at two years: patient alive with functioning graft and minimum estimated glomerular filtration rate thresholds (≥30 mL/min/1.73m 2 for older deceased-donor kidneys; ≥45 mL/min/1.73m 2 for younger deceased donor or living donor kidneys). At two years, the authors observed no statistically significant difference between arms -- 50 percent success in the low-dose arm versus 57 percent in the standard-dose arm. "Importantly, the adapted regimen was safe, but it did not demonstrate superiority over the standard regimen in this older population," Berger said. "Clinicians should be reassured that older transplant recipients achieve very good outcomes under current standard regimens (89 percent patient survival; only 5 to 6 percent graft loss at two years) and that a reduced regimen is safe. We should move toward stratified immunosuppression in older patients with an awareness that immunosuppression can be reduced safely in most cases. Clearly the OPTIMIZE trial had not hit the threshold for reduction of immunosuppression. The study highlights the need for further research to tailor the immunosuppressive regimen to the individual older patient (taking into account donor age, immunosenescence, comorbidities, frailty, etc.)." The study was funded by Chiesi Pharmaceuticals. Abstract No. FR-OR085 ASN: Nearly All Adults With CKD Would Benefit from Systolic BP Target <120 mm Hg WEDNESDAY, Nov. 12, 2025 -- Nearly all adults with chronic kidney disease would benefit from a systolic blood pressure target <120 versus <140 mm Hg, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Similar Risks Seen for Young, Older Patients With Primary Glomerular Diseases WEDNESDAY, Nov. 12, 2025 -- For patients with primary glomerular diseases, young patients face similar risks of kidney function decline as older patients, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Expanding Kidney Transplant Wait-List Criteria to Include Risk for Kidney Failure Could Improve Outcomes WEDNESDAY, Nov. 12, 2025 -- Expanding the wait-listing criteria for kidney transplantation to include risk for kidney failure -- rather than taking a single measurement of kidney function -- could improve outcomes, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: New Tool Predicts CKD Survival With Conservative Management Versus Dialysis WEDNESDAY, Nov. 12, 2025 -- A new tool can predict individualized probability of survival with conservative management versus dialysis transition among individuals with advanced chronic kidney disease, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Large Gap Between Creatinine-Based eGFR and Cystatin C-Based eGFR Tied to Worse Outcomes MONDAY, Nov. 10, 2025 -- In the outpatient setting, the presence of a cystatin C-based estimated glomerular filtration rate that is at least 30 percent lower than creatinine-based eGFR is associated with significantly higher rates of all-cause mortality, cardiovascular events, and kidney failure, according to a study published online Nov. 7 in the Journal of the American Medical Association to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Prevalence of Chronic Kidney Disease Increasing Globally MONDAY, Nov. 10, 2025 -- The prevalence of chronic kidney disease is increasing globally, according to a study published online Nov. 7 in The Lancet to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text

Clinical ResultPhase 2

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

06 Aug 2025

·www.drugs.com

Canagliflozin Tied to Reduction in HbA1c in Children, Teens With T2DM

WEDNESDAY, Aug. 6, 2025 -- Canagliflozin is associated with a clinically meaningful reduction in hemoglobin A1c (HbA1c) for children and adolescents with type 2 diabetes mellitus (T2DM), according to a study published online Aug. 5 in the Annals of Internal Medicine . Ulhas Nadgir, M.D., from Sutter Medical Group in Sacramento, California, and colleagues assessed the safety and efficacy of canagliflozin in children and adolescents aged 10 years or older with T2DM in a phase 3 randomized, placebo-controlled multicenter study conducted in 104 sites in 10 countries. Participants were randomly assigned to canagliflozin (100 mg) or placebo once daily (84 and 87 individuals, respectively); at week 13, participants with week 12 readings of 7 percent or higher for HbA1c and at least 60 mL/min/1.73 m 2 for estimated glomerular filtration rate were randomly assigned to continue receiving 100 mg canagliflozin (or placebo) or to have their dose uptitrated to 300 mg (or placebo). The researchers found that the HbA1c reduction from baseline was significantly greater with canagliflozin versus placebo at week 26 (difference in least-squares means, −0.76 percent). A higher proportion of participants achieved HbA1c levels below 6.5 percent with canagliflozin versus placebo (36.3 versus 14.0 percent, respectively). Among those who received canagliflozin and placebo, treatment-emergent adverse events occurred in 77.4 and 74.7 percent, respectively, and serious treatment-emergent adverse events occurred in 9.5 and 5.7 percent, respectively. "The data from this trial provide support for the use of canagliflozin in the clinical management of T2DM in children and adolescents aged 10 years or older," the authors write. The study was funded by Johnson & Johnson, the manufacturer of canagliflozin. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required)

Phase 3Clinical ResultPhase 2

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	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 Kingdom	Janssen-Cilag International NV	30 Nov 2009
Hypoglycemia	Phase 2	Italy	Janssen-Cilag SA	26 Oct 2016
Diabetes Mellitus, Type 1	Phase 2	United States	Janssen Research & Development LLC	01 May 2014
Diabetes Mellitus, Type 1	Phase 2	Canada	Janssen Research & Development LLC	01 May 2014
Diabetes Mellitus	Phase 2	United States	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2008
Obesity	Phase 2	United States	Johnson & Johnson Pharmaceutical Research & Development LLC	01 May 2008
Hepatocellular Carcinoma	Preclinical	Egypt	National Research Centre	29 May 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02065791 \| NCT01032629 (CANVAS, Pubmed \| Eur J Heart Fail)	Phase 3	-	5,281	Canagliflozin	asublilcys(kuvkclgfaf): HR = 0.65 (95.0% CI, 0.53 - 0.79) View more	Positive	01 Dec 2025
				Placebo
NCT02065791 \| NCT03036150 \| NCT03594110 (CANVAS, Pubmed \| Clin J Am Soc Nephrol)	Phase 3	Chronic Kidney Diseases	4,401	Canagliflozin	gtpfquhpil(ehuvfyujlc): HR = 0.88 (95.0% CI, 0.8 - 0.98), P-Value = 0.02 View more	Positive	01 Sep 2025
				Placebo
NCT03170518 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	171	placebo+canagliflozin (Placebo)	vbbelwkfuj(krzqqthmso) = zcljhfdupu dpmscxuzjv (ytwlvyatbo, 0.191) View more	-	12 Mar 2025
				Canagliflozin (Canagliflozin 100/300 mg)	vbbelwkfuj(krzqqthmso) = fczloiirga dpmscxuzjv (ytwlvyatbo, 0.194) View more
NCT03436693 (CTgov)	Phase 3	Diabetic Nephropathies	308	Canagliflozin (Canagliflozin 100mg)	yqjlqpfotq = pgvzdzfelp nxuffoyxsr (ohvyipshhk, gnrpfsudqo - rqsmdvovjz) View more	-	15 Jul 2024
				Placebo (Placebo)	yqjlqpfotq = hcgbbetgaz nxuffoyxsr (ohvyipshhk, ihfiyaqger - vkqvhgrayb) View more
1340-P (ADA2024)	Not Applicable	Diabetes Mellitus	-	SGLT2i	uzvuszgcip(yvrocwvajn) = anmbsphmpm xingdpoyok (mtlwicdzzr, 16.6 - 19.7)	Positive	14 Jun 2024
				DPP4i	uzvuszgcip(yvrocwvajn) = rgrxpktgkq xingdpoyok (mtlwicdzzr, 19.1 - 21.4)
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin 100 mg/d	xhhxfktiqn(mjipyfrgzo) = vrdsgdbcob wyiwiyrhgv (krvneltrtn ) View more	-	14 Jun 2024
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS Program and CREDENCE trial, Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	otdzndnbsz(bzwuhgfjsh): 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	hoqrradbvv(usxaxksopa) = mieiyivdha ledddifgwx (qhbzbltooy ) View more	-	22 Aug 2023
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS and CREDENCE Trials, Pubmed \| J Am Heart Assoc)	Not Applicable	Diabetes Mellitus, Type 2 \| Cardiovascular Diseases \| Diabetic Nephropathies ... View more	-	Canagliflozin	cafcbtrloo(hnxtxvijbc) = lpznqhnmhf lajqvkynqv (knlwoipkbu )	-	22 Jun 2023
CANVAS Program and CREDENCE trial (ESC2023)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	gwbowtfckh(vfolnykdue): HR = 0.74 (95% CI, 0.66 - 0.84), P-Value = Day 44 View more	-	20 May 2023
				Placebo

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Canagliflozin Hemihydrate

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