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Details:
Zolmitriptan PassPort (zolmitriptan) is a 5-HT1D/5-HT1B binder, small molecule drug, transdermal patch. It is being evaluated in phase 1 clinical trials for the treatment of acute migraine.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Zolmitriptan PassPort
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2024
Details:
Zolmitriptan PassPort (zolmitriptan) is a 5-HT1D/5-HT1B binder, small molecule drug, transdermal patch. It is being evaluated in phase 1 clinical trials for the treatment of acute migraine.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Zolmitriptan PassPort
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2024
Details:
The assets acquired include Zosano’s proprietary microneedle array patch (MAP) intradermal drug delivery system, intended for the epidermal delivery of M207 (zolmitriptan) for the treatment of migraine attacks in adults.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: M207
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emergex Vaccines Holding
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 18, 2023
Details:
Zomig® Nasal Spray is distributed in a unique unit dose presentation and is indicated for the treatment of migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age).
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Zomig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Details:
Company has received feedback from the U.S. Food and Drug Administration Division of Neurology II (the “Division”) on the protocol for the pharmacokinetic study required to support the resubmission of the Qtrypta™ NDA.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
Company has received the official Type A meeting minutes from the U.S. FDA Division of Neurology II regarding the requirements for resubmission of the Qtrypta™ New Drug Application following the Complete Response Letter received on October 20, 2020.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
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.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct 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 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.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 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.
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zosano Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 06, 2020
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