A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease.
The main questions it aims to answer are:
* Is it safe to start these medicines over a short period of time?
* How often do kidney function changes or high potassium levels occur?
* Does this approach lower protein in the urine (a sign of kidney damage)?
* How many participants are able to stay on all four medicines over 6 months?
Researchers will compare this approach to usual care, where medicines are started one at a time over several months.
Participants will:
Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months

Start Date30 Apr 2026

Sponsor / Collaborator

Baylor Research Institute

NCT06600178

/ RecruitingPhase 1IIT

Innovative Therapy to Treat Women With Angina With Nonobstructive Coronary Artery Disease (ANOCA) and Coronary Microvascular Disease

The goal of this clinical trial is to that Sodium-glucose cotransporter 2 inhibitors treatment will improve Coronary Microvascular Disease with anginal symptoms associated with non-obstructive coronary disease in women. The main questions it aims to answer are:
Aim 1: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves coronary microvascular disease in women with no evidence of epicardial obstructive coronary artery disease.
Aim 2: Test the hypothesis that Sodium-glucose cotransporter 2 inhibitors treatment improves angina symptoms and other quality of life measurements associated with the improvement of CFR.
AIM 3: Identify the effect of Sodium-glucose cotransporter 2 inhibition on inflammation pathways and markers of systemic Research will compare Brezavvy to placebo
Participants will:
* Take study drug or placebo for 12 weeks
* Stress Cardiac magnetic resonance imaging
* 12 lead electrocardiograms
* Complete questionnaires

Start Date15 Jul 2025

Sponsor / Collaborator

University of Virginia

NCT05612594

/ RecruitingPhase 4IIT

Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study

The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug).
The main question it aims to answer is:
* If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants
* If improvement in clinical measures are because of improvement in the anatomic and physiologic traits.
Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.

Start Date27 Mar 2024

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Bexagliflozin

100 Translational Medicine associated with Bexagliflozin

100 Patents (Medical) associated with Bexagliflozin

Literatures (Medical) associated with Bexagliflozin

01 Jul 2026·JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS

Pharmacokinetics of Bexagliflozin After Intravenous and Oral Administration in Cats

Article

Author: Patel, Yogini ; Bhattarai, Sheeva ; Toutain, Céline E.

ABSTRACT:

Bexagliflozin, a selective sodium–glucose cotransporter 2 (SGLT2) inhibitor, has been developed for feline diabetes mellitus. This study characterized bexagliflozin pharmacokinetics in healthy cats after single intravenous and oral administrations. Sixteen adult cats received a 1 mg/kg intravenous solution and a 15 mg oral tablet (Bexacat) in a two‐period study under fasted conditions. Serial plasma samples were collected up to 72 h and analyzed by a validated LC–MS/MS method (calibration range 1–2000 ng/mL). Pharmacokinetic parameters were derived by non‐compartmental analysis. Following intravenous dosing, bexagliflozin showed a low plasma clearance of 348 mL/h/kg. The volumes of distribution during the terminal phase ( Vz ) and at steady‐state ( VSS ) were 3.5 and 1.7 L/kg, respectively. The terminal half‐life was 7.0 h. After oral dosing of the tablet, absorption was rapid (median Tmax 1 h; range 0.5–4 h), with Cmax of 1780 ng/mL and a terminal half‐life of 6.9 h. Absolute bioavailability was 78% (90% confidence interval: 73%–83%). Exposure was comparable between males and females after both routes (AUC ratios ~97%–103%). Treatments were well tolerated. These pharmacokinetic data indicate bexagliflozin exhibits rapid absorption, high oral bioavailability, and a half‐life compatible with once‐daily dosing in cats.

01 Jun 2026·DIABETES RESEARCH AND CLINICAL PRACTICE

Cardiovascular outcomes of novel SGLT2 inhibitors in patients with type 2 diabetes: a network meta-analysis of bexagliflozin, ertugliflozin and sotagliflozin

Review

Author: Ho, Wen-Chao ; Chen, Hung-Yi ; Chu, Wei-Min ; Yang, Yi-Zhen ; Lung, Wei-Chun ; Dao, Tien-Phat ; Chen, Pau-Chung ; Tsan, Yu-Tse

We conducted a systematic review and network meta-analysis to examine the overall and comparative cardiovascular outcomes of bexagliflozin, ertugliflozin, and sotagliflozin in type 2 diabetes patients. We included phase 3 or higher randomized controlled trials sourced from four databases: ClinicalTrials.gov, PubMed, Cochrane CENTRAL and Embase. A random-effects model was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). The primary endpoint was a composite of cardiovascular death or hospitalization for heart failure. The secondary endpoints were cardiovascular death, hospitalization for heart failure and all-cause mortality. Compared with placebo, bexagliflozin, ertugliflozin and sotagliflozin reduced composite cardiovascular death or hospitalization for heart failure (OR, 0.66 [95% CI 0.48-0.89]), hospitalization for heart failure (OR, 0.62 [0.55-0.70]) and acute coronary syndrome (OR, 0.35 [0.16-0.77]). No significant differences were observed among the three drugs for primary and secondary outcomes, although bexagliflozin (OR, 0.39 [0.16-0.94]) and sotagliflozin (OR, 0.41 [0.23-0.72]) had lower risks of myocardial infarction than did ertugliflozin. In conclusion, bexagliflozin, ertugliflozin, and sotagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure. Bexagliflozin and sotagliflozin may offer additional benefits in preventing the risk of myocardial infarction.

08 May 2026·JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION

Bexagliflozin controls hyperinsulinemia in horses with naturally occurring insulin dysregulation: a placebo-controlled crossover trial

Article

Author: Luethy, Daniela ; Skelton, Georgia ; van Eps, Andrew W. ; Stefanovski, Darko ; Kulp, Jeaneen ; Lowndes, Caitrin R.

Abstract:

Objective:

To evaluate bexagliflozin for insulin control in horses with naturally occurring insulin dysregulation.

Methods:

In a randomized, placebo-controlled crossover study, 10 client-owned Arabian horses with hyperinsulinemia (> 30 μIU/mL) were treated with bexagliflozin (0.03 mg/kg, PO, q 24 h; BEXA03) or placebo control for a 10-day treatment period, crossing over after a 4-day washout. After a further 12-day washout, 8 of the horses were treated with bexagliflozin (0.06 mg/kg, PO, q 24 h; BEXA06) for an additional 7-day treatment period. Oral sugar tests were performed at the beginning of each treatment period (untreated control) and on the final day of each treatment course. Insulin, glucose, triglycerides, and adipokines were compared with mixed-effects linear regression.

Results:

Mean resting, maximal (C max ), and area under the curve (AUC) insulin were lower after BEXA06 (resting, 17.6 μIU/mL [95% CI, 5.3 to 29.9 μIU/mL]; C max , 48.4 μIU/mL [95% CI, 24.0 to 72.8 μIU/mL]; AUC, 4,084.0 μIU/mL*min [95% CI, 1,944.4 to 6,223.5 μIU/mL*min]) compared to placebo control (resting, 53.9 μIU/mL [95% CI, 35.0 to 72.7 μIU/mL]; C max , 90.9 μIU/mL [95% CI, 65.0 to 116.9 μIU/mL]; AUC, 9,146.3 μIU/mL*min [95% CI, 6,428.9 to 11,863.7 μIU/mL*min]), but not after BEXA03. Mild hypertriglyceridemia was observed in some horses following treatment with BEXA06 (n = 5), but mean resting triglyceride concentrations were not significantly higher for BEXA06 (49 mg/dL; 95% CI, 30 to 67 mg/dL) compared to the untreated control (32 mg/dL; 95% CI, 26 to 38 mg/dL).

Conclusions:

Bexagliflozin (0.06 mg/kg, PO, q 24 h) controlled insulin with minimal impact on serum triglycerides in Arabian horses with naturally occurring insulin dysregulation.

Clinical Relevance:

Treatment with bexagliflozin was effective for the short-term management of naturally occurring insulin dysregulation in horses.

News (Medical) associated with Bexagliflozin

01 Jun 2026

·www.einpresswire.com

OneroRx Launches Lower-Cost Diabetes Medication Brenzavvy

WEST DES MOINES, IA, UNITED STATES, June 1, 2026 / EINPresswire.com / -- OneroRx, a community-focused healthcare provider, announced the immediate availability of Brenzavvy (Bexagliflozin), a lower-cost SGLT2 inhibitor for adults with type 2 diabetes. Approved by the FDA in 2023 and developed by TheracosBio, Brenzavvy helps improve blood glucose control while addressing a major barrier to care: affordability. As one of the most cost-effective options in its class, it aims to support better adherence and long-term outcomes. “We understand the challenges of managing diabetes and are committed to providing affordable solutions,” Joseph Dunham said, Chairman and CEO of OneroRx. “From Brenzavvy to our Contonious Glucose Monitor (CGM) offerings, we’re helping patients take control of their health with confidence.” TheracosBio CEO Brian Connelly added, “We are excited to partner with OneroRx to make low-cost, safe, and effective Brenzavvy available to more patients. The community-focused healthcare approach at OneroRx is a perfect fit with our mission to offer affordable therapeutics to those in need.” Brenzavvy is now available at select OneroRx pharmacies, including: Medicap Pharmacy, Urbandale IA, Sinks Pharmacy, Rolla MO, Lee’s Summit Pharmacy, Lee’s Summit MO, Local Health Pharmacy, Chicago IL, Juniper Pharmacy, St. Louis MO, and Willowbrook Pharmacy, Carmel IN. Special Launch Offer For a limited time, patients can receive $38 off a three-month supply. Patients should consult their pharmacist or healthcare provider to determine eligibility. “We remain committed to expanding offerings and making healthcare more accessible,” Dunham added. “We thank our partners for helping create this affordable path to wellness.” For more information or to find a participating pharmacy, visit https://www.onerorx.com/patient . About OneroRx OneroRx provides affordable, high-quality pharmacy services to underserved communities, filling over 5 million prescriptions annually across 92 locations in eight states. About TheracosBio Founded in 2004, TheracosBio develops affordable therapeutics for diseases with significant societal impact. Craig Olson OneroRx Inc craig.olson@onerorx.com Visit us on social media: LinkedIn 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.

12 Dec 2024

·www.businesswire.com

A Study in the New Issue of JAMA Network Open Reveals Income-Related Disparities in Type 2 Diabetes Outcomes Despite Equivalent Access to Healthcare

MARLBOROUGH, Mass.--( BUSINESS WIRE )--A new study published in JAMA Network Open titled “ Income-Related Disparities in Mortality Among Young Adults With Type 2 Diabetes ” underscores the need for addressing disparities in care and improving access to important therapies for type 2 diabetes. This study further underscores recent data compiled by the American Diabetes Association which states that diabetes is the most expensive chronic condition in the United States, and millions of Americans struggle to afford effective treatment of their type 2 diabetes and associated complications. Seeking to address this critical health issue, BRENZAVVY ® (bexagliflozin) is a safe, effective and affordable option for adults with type 2 diabetes. In the United States, BRENZAVVY is sold at around $50 per month through a network of online and independent pharmacies. BRENZAVVY's low price point makes sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy a more affordable option for uninsured, underinsured, and Medicare patients. This increased affordability can help ensure that patients can initiate and maintain a safe and effective therapy, improving their ability to manage their type 2 diabetes. Adults with type 2 diabetes can easily determine if BRENZAVVY is right for them by visiting www.brenzavvydirect.com and speaking to a doctor quickly and affordably. For healthcare providers, BRENZAVVY can easily be prescribed without insurance plan headaches, such as prior authorizations or step therapy hurdles, that the SGLT2 inhibitor class traditionally faces. “ The findings of this study reinforce that many adults living with type 2 diabetes simply cannot afford to start and stay on their therapy ,” said the TheracosBio CEO, Brian Connelly. “ With BRENZAVVY, TheracosBio is fulfilling our mission to address financial barriers to care. By unlocking wider access to an important class of therapy, more and more people with type 2 diabetes have better access to a safe, affordable and effective treatment option,” Mr. Connelly added. BRENZAVVY is available as 20 mg oral tablets to be taken once daily, in the morning, with or without food. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents. Although BRENZAVVY is not approved for weight loss or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program. To learn more about BRENZAVVY , please visit https://www.brenzavvy.com . To learn more about TheracosBio, please visit https://theracosbio.com . BRENZAVVY Important Safety Information BRENZAVVY ® (bexagliflozin) is a prescription medicine used along with diet and exercise to improve blood sugar in adults with type 2 diabetes. BRENZAVVY is not recommended to decrease blood sugar in people with type 1 diabetes. Do not take BRENZAVVY if you are allergic to bexagliflozin or any of the ingredients in BRENZAVVY. BRENZAVVY can cause serious side effects including diabetic ketoacidosis that may be fatal. Signs and symptoms of ketoacidosis include nausea, vomiting, stomach pains, tiredness, trouble breathing, and ketones in urine or blood. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. BRENZAVVY may increase the risk of lower limb amputations. Call your doctor if you notice signs or symptoms. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation. BRENZAVVY may cause dehydration, urinary tract or genital yeast infections, and low blood sugar. Symptoms of dehydration include feeling dizzy, faint, lightheaded, or weak upon standing. Yeast infections can occur in women and men. Signs of low blood sugar may include headache, confusion, drowsiness, dizziness, sweating, irritability, hunger, shaking, fast heartbeat, or weakness. A rare life-threatening bacterial infection in the skin of the perineum could occur. Stop taking BRENZAVVY and call your doctor right away if you have symptoms of this infection The perineum is the area between the anus and genitals. Symptoms of this infection include fever, weakness and pain tenderness, redness, or swelling of the genital area. The most common side effects of BRENZAVVY are vaginal yeast infections, urinary tract infections, and changes in urination, including an urgent need to urinate more often, in large amounts, and at night. For additional important safety information about BRENZAVVY, visit www.brenzavvy.com . About TheracosBio TheracosBio was founded in 2000 and develops affordably priced novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases. COM-23118-01

Phase 3Drug Approval

18 Oct 2024

·www.pharmaceutical-technology.com

TheracosBio and BAMCO to bring BRENZAVVY to sub-Saharan Africa for T2D

Results from Phase III clinical trials have demonstrated that BRENZAVVY significantly lowers haemoglobin A1c and fasting blood sugar levels over 24 weeks. Credit: Dragana Gordic/Shutterstock. TheracosBio has entered a partnership with BAMCO Africa to deliver BRENZAVVY (bexagliflozin), a type 2 diabetes (T2D) treatment, to patients in sub-Saharan Africa. The collaboration is based on a shared mission between the two companies. This initiative follows TheracosBio’s collaboration with SmithRx in August 2023 aimed at improving access to BRENZAVVY for adults with T2D. TheracosBio CEO Brian Connelly stated: “The mission of TheracosBio is to bring effective treatments to patients in need at affordable prices and BAMCO is working to do the same for patients in sub-Saharan Africa. “We are excited to work with BAMCO to provide doctors and their patients in the region with access to BRENZAVVY, a cost-effective therapy to manage type 2 diabetes.” See Also: Health Canada approves Acadia’s DAYBUE for Rett syndrome COPD market expected to grow to $30.8bn in the 7MM by 2033 BRENZAVVY, an oral sodium-glucose cotransporter 2 inhibitor, received approval from the US Food and Drug Administration (FDA) in January 2023 and is now set to make its mark in the African market. It is indicated for adults with T2D and an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher, which includes those with stage three chronic kidney disease. BAMCO Africa CEO Markus Gemuend stated: “BAMCO’s mission is that all patients in sub-Saharan Africa deserve better and need to have equitable and timely access to the latest innovative treatments that save and improve their lives. “We are thrilled to partner with TheracosBio to provide access to BRENZAVVY for patients with type 2 diabetes, a fast-growing health burden, and engage with medical communities to launch this innovative treatment in sub-Saharan Africa.” Results from Phase III clinical trials have demonstrated that BRENZAVVY lowers haemoglobin A1c and fasting blood sugar levels over 24 weeks. While not specifically approved for weight loss or reduction in blood pressure, clinical studies have noted positive improvements in these areas among patients taking the treatment.

Phase 3Drug Approval

100 Deals associated with Bexagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10865	-	-	DB12236

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	Theracos, Inc.	20 Jan 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 3	United States	Theracos, Inc.	18 Oct 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03259789 (Biospace) Manual	Phase 3	Diabetes Mellitus, Type 2	317	Brenzavvy+Metformin	aciqefaynq(pmmqswzwhp) = xahldwhwow numfnrkrgt (wjnilbbfya ) View more	Positive	04 Aug 2023
				placebo+Metformin	aciqefaynq(pmmqswzwhp) = jwkmmlbhqr numfnrkrgt (wjnilbbfya ) View more
NCT03115112 (FDA) Manual	Phase 3	Diabetes Mellitus, Type 2	384	BRENZAVVY+Metformin	xzjydiwlfj(dkuvodkddd) = cjovgwmpyq ltzrixzbvc (wqkobjvjuj, 0.1) View more	Positive	20 Jan 2023
				Sitagliptin+Metformin	xzjydiwlfj(dkuvodkddd) = clkcqpzvrn ltzrixzbvc (wqkobjvjuj, 0.1) View more
NCT02836873 (FDA) Manual	Phase 3	Diabetes Mellitus, Type 2	312	Placebo	dgvmizewrv(swrwaokvqz) = qoegqovwck zcknwgdian (ygsidtvgkm, 0.1) View more	Positive	20 Jan 2023
				BRENZAVVY	dgvmizewrv(swrwaokvqz) = hukgkdhrff zcknwgdian (ygsidtvgkm, 0.1) View more
NCT02715258 (FDA) Manual	Phase 3	Diabetes Mellitus, Type 2	207	BRENZAVVY 20 mg	wpjqnalchx(eyajhkzrzq) = rkpqarhtno deexcwnade (yeygdmdrsj, 0.1) View more	Positive	20 Jan 2023
				Placebo	wpjqnalchx(eyajhkzrzq) = luglihjysi deexcwnade (yeygdmdrsj, 0.1) View more
NCT02769481 (FDA) Manual	Phase 3	Diabetes Mellitus, Type 2	426	BRENZAVVY+Metformin	brzimmlfft(xjpxkgruis) = equbghpdsp lptckrbfbz (pugwnycgbd, 0.1) View more	Positive	20 Jan 2023
				Glimepiride+Metformin	brzimmlfft(xjpxkgruis) = xrsoicdhqr lptckrbfbz (pugwnycgbd, 0.1) View more
NCT03259789 (FDA) Manual	Phase 3	Diabetes Mellitus	317	BRENZAVVY+ Metformin	hlbmpetebj(tcbysfcajv) = ytfapaifdb jszbwtohwa (jiwzbwnnso, 0.1) View more	Positive	20 Jan 2023
				Placebo+ Metformin	hlbmpetebj(tcbysfcajv) = wfdncwcosj jszbwtohwa (jiwzbwnnso, 0.1) View more
NCT02558296 (FDA) Manual	Phase 3	Diabetes Mellitus, Type 2	1,701	Placebo	filulvpeto(zahrjqzlvj) = hbnpuchmiz xpwswuarnh (uermqgksvn, 0.04) View more	Positive	20 Jan 2023
				BRENZAVVY	filulvpeto(zahrjqzlvj) = lztnworsbx xpwswuarnh (uermqgksvn, 0.03) View more
NCT03514641 (CTgov)	Phase 2/3	Essential Hypertension	673	Bexagliflozin (Bexagliflozin Tablets, 20 mg)	oqaiodeumo(gqziqeuzkk) = nbopiwvbty hpzijirvhm (djqmwzsnei, 0.642) View more	-	21 Sep 2021
				Placebo (Placebo Tablets)	oqaiodeumo(gqziqeuzkk) = qjonaovgqp hpzijirvhm (djqmwzsnei, 0.622) View more
NCT02956044 (CTgov)	Phase 1	Diabetes Mellitus, Type 2	54	Bexagliflozin (Group 1: Bexagliflozin Alone)	fcnaveeqdj(sjphmtrdnb) = jqdyallhft pxgjiwkubn (gkwmdeernw, 43.7) View more	-	22 Jul 2021
				Metformin (Group 1: Metformin Alone)	tyinonroam(acehngubof) = uprhpzibgo dlztwzcmfy (lfeeunmqaz, 27.2) View more
NCT03197324 (CTgov)	Phase 1	Diabetes Mellitus, Type 2	20	Digoxin (Digoxin Alone)	rdooyohbiy(uuakupezuy) = xrmcrdexrj skktoibnfq (gqqceancfd, 28.8) View more	-	16 Jul 2021
				Digoxin+Bexagliflozin (Digoxin With Bexagliflozin)	rdooyohbiy(uuakupezuy) = membwolrxc skktoibnfq (gqqceancfd, 40.9) View more

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