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

NCT06913647

/ 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 Feb 2026

Sponsor / Collaborator

Canadian Institutes of Health Research

100 Clinical Results associated with Canagliflozin Hemihydrate

100 Translational Medicine associated with Canagliflozin Hemihydrate

100 Patents (Medical) associated with Canagliflozin Hemihydrate

1,918

Literatures (Medical) associated with Canagliflozin Hemihydrate

01 Jun 2026·International journal of cardiology. Cardiovascular risk and prevention

Renal and cardiovascular effects of SGLT2 inhibitors among hypertensive patients with chronic kidney disease: A systematic review and meta-analysis

Review

Author: Danny, Siska Suridanda ; Kuncoro, Brm Ario Suryo ; Kosen, Yosua Darmadi ; Amalia, Fauqi ; Dharma, Ahmad Surya ; Pintaningrum, Yusra ; Javier, R Mohamad ; Faizin, Iqbal ; Fiohana, Puput ; Nurpradika, Brianka Yudha ; Firasghani, Muhammad Almy ; Kurniawan, Kristian ; Puspitasari, Renny Anggraeni ; Andiani ; Samudra, Dian

Background:

Chronic kidney disease (CKD) is frequently complicated by hypertension, a dual contributor to disease progression and cardiovascular risk. Despite standard therapy with renin-angiotensin-aldosterone system inhibitors, residual risk remains high. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have emerged as a novel therapy with proven renal and cardiovascular benefits, but their effects in hypertensive CKD patients remain less well defined.

Methods:

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated SGLT2 inhibitors in CKD patients with baseline systolic blood pressure ≥140 mmHg or renovascular disease. PubMed, Embase, and Cochrane Library were searched from inception to August 2024. Eligible RCTs compared an SGLT2 inhibitor versus placebo and reported outcomes in hypertensive subgroups. Primary outcome was a composite of kidney failure, sustained decline in estimated glomerular filtration rate (eGFR ≥40-50 %), or cardiovascular death. Secondary outcomes included kidney-specific endpoints, cardiovascular composite outcomes, and serious adverse events (SAEs). Pooled odds ratios (ORs) were calculated using random-effects models.

Results:

Three RCTs were included: CREDENCE (canagliflozin), DAPA-CKD (dapagliflozin), and EMPA-KIDNEY (empagliflozin), encompassing 5436 hypertensive participants. For the primary outcome, SGLT2 inhibitors reduced risk compared with placebo (OR 0.76, 95 % CI 0.65-0.88). Kidney outcomes showed consistent benefit (OR 0.70, 95 % CI 0.58-0.85). Cardiovascular events were modestly reduced (OR 0.79, 95 % CI 0.64-0.97). SAEs were slightly lower with SGLT2 inhibitors (OR 0.85, 95 % CI 0.74-0.96). Overall certainty of evidence was graded as moderate.

Conclusions:

Among hypertensive patients with CKD, SGLT2 inhibitors significantly reduce renal disease progression and cardiovascular events while maintaining favorable safety. These findings support their integration into standard therapy for this high-risk population.

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 Apr 2026·CURRENT PHARMACEUTICAL DESIGN

Inclusion Complexes of α and β -cyclodextrin with Canagliflozin Hemihydrate: Design and Characterization

Article

Author: Sagdeo, Archna ; Semalty, Ajay ; Gupta, Mukul ; Pandey, Mukesh ; Chitra ; Gauniya, Priyanka ; Radheshyam ; Semalty, Mona

Introduction::

Canagliflozin hemihydrate (CANA), an antidiabetic drug that functions as a sodiumglucose co-transporter 2 (SGLT2) inhibitor, is classified under the Biopharmaceutical Classification System (BCS) as a Class IV drug, characterized by low solubility and low permeability. This study aimed to enhance the solubility, dissolution, and permeability of CANA by preparing its inclusion complexes with α- cyclodextrin (α-CD) and β-cyclodextrin (β-CD), followed by characterization of their crystalline and biopharmaceutical properties.

Methods::

The solubility of CANA in aqueous medium and phase solubility with α and β-cyclodextrin were conducted. The inclusion complexes in different CANA: α-CD ratios (1:0.25 to 1:6 mM) and CANA: β-CD ratios (1:0.50 to 1:8 mM) were prepared using the freeze-drying method. The complexes were subjected to drug content analysis, Fourier transform infrared spectroscopy (FTIR), X-ray powder diffraction (XRPD), angle- dispersive X-ray diffraction (ADXRD), in vitro dissolution, and permeation studies.

Results::

Phase solubility study indicated significant improvements in aqueous solubility of CANA with α-CD and β-CD. The solubility of CANA increased significantly (more than 100-fold in BCD8 with 0.577 mg/mL) upon complexation. BCD8 (1:7) with 97.366% and ACD6 (1:4) with 94.6% showed the highest % drug content. FTIR confirmed interactions between CANA and CDs due to the disappearance or shifting of some characteristic peaks (e.g., 3390.68 to 3268.91 cm-1 and 1078.07 to 1024.06 cm-1 in ACD6, while 3265.05 to 3268.91 cm⁻¹ and 1025.99 to 1024.06 cm⁻¹ in ACD7).

Discussion::

XRPD and ADXRD showed the crystalline nature of CANA and CDs, while the complexes exhibited amorphization with diffused peaks. The lowest crystallite size was observed in ACD6 (449.688) and the highest in ACD3 (966.936 Å). D-spacing was found to be smallest in ACD8 (0.722 Å) and BCD6 (4.080 Å), and the highest in ACD1 (7.276 Å), BCD7, and BCD8 (7.063 Å). The drug release ranged from 64.265% (ACD3) to 94.306% (BCD7) and increased with lower crystallinity. ACD8 (87.33%) and BCD7 (93.41%) exhibited the highest % of drug permeability.

Conclusion::

Inclusion complexation with α-CD and β-CD significantly improved the solubility and dissolution of CANA in aqueous medium. These findings suggest that cyclodextrin-based inclusion complexes offer a promising approach to enhancing the biopharmaceutical performance of poorly soluble drugs, such as CANA.

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

03 Sep 2025

·www.lerner.ccf.org

Patient data points to promising link between GLP-1 medications, weight loss drugs and Alzheimer’s disease

Diabetes is a major risk factor for Alzheimer’s disease, but controlling blood sugar alone doesn’t prevent neurodegeneration. Cleveland Clinic researchers analyzed two decades worth of patient data and uncovered a promising connection between certain diabetes medications, including weight loss drugs, and Alzheimer’s disease outcomes. The study, published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, analyzed publicly available data from 400,000 individuals who took antidiabetic medications between 2007 and 2025. Prescribing an antidiabetic medication requires an individualized approach. This can include whether a patient needs to lose weight, what other conditions the patient may have, cost and side effects. The research team, co-led by Feixiong Cheng, PhD, Director of Cleveland Clinic’s Genome Center, analyzed multiple types of antidiabetic drugs to add another factor: long-term neuroprotection. The Cheng Lab examined three classes of antidiabetic medication for their neuroprotective effects: GLP-1 receptor agonists, including semaglutide and liraglutide; SGLT2 inhibitors, including dapagliflozin, canagliflozin and empagliflozin; and DPP-4 inhibitors (gliptins). “Although antidiabetic drugs all help manage blood sugar, they work through different biological pathways,” Dr. Cheng explains. “We wanted to know if some of these medications could also target mechanisms directly linked to the brain and neurodegeneration, and we wanted to know whether individuals with diabetes would need to change from their optimal medication to protect their neurological health.” The team analyzed a database of 80 million older (>60 years) patients to see whether any of these medications were associated with lower rates of Alzheimer’s diagnoses. Almost half a million were included in the study. The findings showed that individuals who took a GLP-1 agonist or SGLT2 inhibitor made 25% - 50% fewer insurance claims related to neurodegenerative disease than individuals who took DPP-4 inhibitors to control their diabetes. There was no significant difference between GLP-1 receptor agonists and SGLT-2 inhibitors. "When it comes to GLP-1 RAs, we also found that semaglutide was associated with a ~30-50% reduced risk of Alzheimer's disease in obese individuals, but wasn't significant in people with a normal body mass index,” Dr. Cheng says. “Whether semaglutide has clinical efficacy in individuals with normal weight is still being studied.” The results provide preliminary evidence for further studies to validate the neuroprotective benefits of GLP-1 RAs and SGLT-2 inhibitors, and, after validation, to untangle the mechanisms of how GLP-1 drugs may help protect the brain. “It’s crucial to investigate whether GLP-1 receptor agonists and SGLT-2 inhibitors could serve as disease-modifying therapies for Alzheimer’s disease in humans by targeting the disease’s biology directly, beyond the drugs’ known anti-diabetic effects,” Dr. Cheng says. “Clinical trials testing these medications are also underway based on the 2025 Alzheimer’s Disease Drug Development Pipeline, but we hope our findings will help direct more targeted, thoughtful clinical trials in the future."

Clinical Result

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

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 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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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05367063 (Pubmed \| Diabetologia)	Phase 2	Diabetes Mellitus, Type 2	45	Canagliflozin 100 mg/day	kalumogeok(rciyrsnrbc) = zmnbbmurhj nlndaxbcuj (fkynieukeu ) View more	Positive	24 Feb 2026
				Sitagliptin 100 mg/day	titpihnvkp(wdnkkliybz) = lcphwnjvhd euglnsynje (wzxfsasevc )
NCT02065791 \| NCT01032629 (CANVAS, Pubmed \| Eur J Heart Fail)	Phase 3	-	5,281	Canagliflozin	xbhqoopbpn(ixwkjqccky): 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	ioyzumsavh(tbsnzxjvku): 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)	xwvdgbyzlx(nbgukddbzm) = pblauswexc ecqfdgewen (iaveqyoroo, 0.191) View more	-	12 Mar 2025
				Canagliflozin (Canagliflozin 100/300 mg)	xwvdgbyzlx(nbgukddbzm) = hmhoqcovbj ecqfdgewen (iaveqyoroo, 0.194) View more
NCT03436693 (CTgov)	Phase 3	Diabetic Nephropathies	308	Canagliflozin (Canagliflozin 100mg)	ijomccxtzx = setjpebgaj mqfaiphqut (cjgsrzskcp, yrbozcdbrm - mnsgtgqyjv) View more	-	15 Jul 2024
				Placebo (Placebo)	ijomccxtzx = lokfmmaood mqfaiphqut (cjgsrzskcp, aqfqxsjndn - txhefrlczv) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin 100 mg/d	fihwacfxks(zpirafwxlh) = sdyixjdavy okccjtrvqs (yprzkhcqui ) View more	-	14 Jun 2024
1340-P (ADA2024)	Not Applicable	Diabetes Mellitus	-	SGLT2i	puqodwicbe(fnepjnvhrx) = qllkyjilca wrjyyshnci (uyqpmmsdxi, 16.6 - 19.7)	Positive	14 Jun 2024
				DPP4i	puqodwicbe(fnepjnvhrx) = ilnadphdls wrjyyshnci (uyqpmmsdxi, 19.1 - 21.4)
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS Program and CREDENCE trial, Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	-	Canagliflozin	xbylbmemln(hakwzlptta): 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	wkpvzjrifz(qqwnwqwbsv) = oucyulepeg tvwamzbzie (mrbsubchgg ) 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	xpfrtfosnq(ispdkqxhst) = kthubxvsbo gnnwsltdrt (dhcbwgkqwd )	-	22 Jun 2023

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Canagliflozin Hemihydrate

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