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About Mirabegron (Alpha) API

Product
  • Therapeutic CategoryUrology

  • CAS Number

    223673-61-8

  • API Technology

    Synthetic

  • Dose Form

    ER Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, CEP Submitted

Mechanism of Action

Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

Indication

MYRBETRIQ is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

MYRBETRIQ, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency

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Related Resources

Dr. Reddy's Mirabegron API offering in both alpha and amorphous form

Dr. Reddy's Mirabegron API offering in both alpha and amorphous form

Read through our technical sheet on Mirabegron API to get a glimpse of our multi-step scalable synthetic approach with effective analytical characterization resulting in a highly pure API. Dr. Reddy's is among the earliest generic API manufacturers globally and filed the USDMF for Mirabegron API (α-form) in June 2014. We have also developed an amorphous form of Mirabegron, which has been filed in the US in February 2015.Read the technical sheet on this topic by filling the contact form below.
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.