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Find Clinical Drug Pipeline Developments & Deals by Zosano Pharma

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            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 21, 2020

            Details:

            The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies and recommended the company to conduct a repeat bioequivalence study between three of the lots used during development.

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            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

            Details:

            The DRL described two concerns regarding clinical pharmacology section of the NDA; (i) regarding unexpected high plasma concentrations of zolmitriptan observed from two pharmacokinetic studies; (ii) the FDA raised questions regarding differences in zolmitriptan exposures.

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            Lead Product(s): Zolmitriptan

            Therapeutic Area: Neurology Product Name: Qtrypta

            Highest Development Status: Phase III Product Type: Small molecule

            Recipient: Eversana

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 06, 2020

            Details:

            Zosano and EVERSANA will utilize EVERSANA’s commercial execution expertise for marketing, market access, distribution, sales force deployment, reimbursement, and patient adherence support services. EVERSANA to commercialize and distribute Qtrypta™ in the United States.