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Home » Directories » FDA Approved Drugs » Brenzavvy (bexagliflozin)

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Brenzavvy (bexagliflozin)

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Profile

Contact Information

Contact: TheracosBio
Website: https://theracosbio.com/

Currently Enrolling Trials

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    General Information

    Brenzavvy (bexagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.

    Brenzavvy is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

    Brenzavvy is supplied as tablets for oral administration.

    • The recommended dose is 20 mg orally taken once daily in the morning, with or without food . 
    • Do not crush or chew the tablet. 
    • If a dose is missed, take the missed dose as soon as possible. Do not double the next dose.
    • Assess renal function before initiating Brenzavvy and as clinically indicated. 
    • Correct volume depletion before initiating. 
    • Not recommended if eGFR less than 30 mL/min/1.73 m.

    Mechanism of Action

    Brenzavvy (bexagliflozin) is an inhibitor of sodium-glucose co-transporter 2 (SGLT2), the transporter responsible for reabsorption of the majority of glucose from the renal glomerular filtrate in the renal proximal tubule. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

    Side Effects

    Adverse effects associated with the use of Brenzavvy may include, but are not limited to, the following:

    • female genital mycotic infections
    • urinary tract infection
    • increased urination

    Clinical Trial Results

    The FDA approval of Brenzavvy was based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. Phase 3 studies showed Brenzavvy significantly reduced 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.

    Approval Date: 2023-01-01
    Company Name: TheracosBio
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