Zogenix, Inc.
U.S. affiliate of a global biopharmaceutical company focused on discovery, development, regulatory approval, and delivery of therapies for neurologic, immunologic and rare diseases. U.S. activities described on the site include clinical development and trial registration, clinical pharmacology and nonclinical toxicology, formulation and finished-product supply, pharmacovigilance and safety monitoring, patient support call-center operations, transparency and Open Payments reporting, and a documented ethics and compliance program covering policies, training, risk assessment, auditing, and third-party due diligence.
Industries
Nr. of Employees
Very Large (1000+)
Zogenix, Inc.
Patents
Products
Brivaracetam (antiseizure active ingredient)
Active ingredient used for treatment of partial-onset seizures, available in multiple dosage forms (tablets, oral solution, IV) with documented dosing and pharmacokinetic information.
Certolizumab pegol (pegylated anti-TNF biologic)
Pegylated tumor necrosis factor (TNF) inhibitor indicated for selected immune-mediated inflammatory conditions; includes prescribing information and patient support guidance.
Portfolio of marketed therapies in neurology, immunology and rare diseases
Commercialized prescription therapies across neurology, immunology and rare-disease indications as listed on the U.S. product index.
Brivaracetam (antiseizure active ingredient)
Active ingredient used for treatment of partial-onset seizures, available in multiple dosage forms (tablets, oral solution, IV) with documented dosing and pharmacokinetic information.
Certolizumab pegol (pegylated anti-TNF biologic)
Pegylated tumor necrosis factor (TNF) inhibitor indicated for selected immune-mediated inflammatory conditions; includes prescribing information and patient support guidance.
Portfolio of marketed therapies in neurology, immunology and rare diseases
Commercialized prescription therapies across neurology, immunology and rare-disease indications as listed on the U.S. product index.
Services
Centralized telephone, email and web-form support providing product information, assistance locating clinical trials, financial-assistance navigation, peer/support-group referrals and adverse-event or product-quality reporting; published hours of operation and contact channels.
Web-based public listing and referral to clinical registries for U.S.-based studies including recruitment status and site details.
Development and publication of prescribing information, medication guides and regulatory safety updates for marketed products to meet U.S. regulatory requirements.
Operational support for ethics and compliance activities including policy dissemination, training, risk assessment, auditing, investigations and third-party due diligence.
Centralized telephone, email and web-form support providing product information, assistance locating clinical trials, financial-assistance navigation, peer/support-group referrals and adverse-event or product-quality reporting; published hours of operation and contact channels.
Web-based public listing and referral to clinical registries for U.S.-based studies including recruitment status and site details.
Development and publication of prescribing information, medication guides and regulatory safety updates for marketed products to meet U.S. regulatory requirements.
Operational support for ethics and compliance activities including policy dissemination, training, risk assessment, auditing, investigations and third-party due diligence.
Expertise Areas
- Clinical trial management
- Clinical pharmacology and population PK
- Pharmacovigilance and safety monitoring
- Formulation development (oral and parenteral)
Key Technologies
- Population pharmacokinetic modeling
- Clinical pharmacology study methods
- Drug–drug interaction assessment (CYP profiling)
- In vitro enzyme and transporter assays
News & Updates
News story published on the U.S. site.
News story about efforts related to thymidine kinase 2.
News story published on the U.S. site.
News story about efforts related to thymidine kinase 2.