ZEPIZURE Development Plan Expanded for Pediatric Use
Federal health officials have consolidated the development timeline to bring this emergency seizure treatment to children.
Updated on Sept. 23, 2026 in Allergies
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The Biomedical Advanced Research and Development Authority (BARDA) and Crossject have merged their development plans for the pediatric indication of the ZEPIZURE midazolam autoinjector. This effort, supported by a $4.7 million funding increase, aims to ensure the device is ready for U.S. emergency preparedness needs.
Why it matters
Aligning the development of pediatric seizure treatments with FDA guidance is critical to ensuring that emergency tools are safe and effective for younger populations. This move streamlines the path for these autoinjectors to be integrated into broader national emergency response protocols.
BARDA has increased its investment in ZEPIZURE development to a total of $48.0 million, supporting both adult and pediatric formulations. The project includes a validation campaign for long-term product stability and inventory management under a contract extended through 2030.
The players
BARDA
The Biomedical Advanced Research and Development Authority is a federal agency that manages development and procurement of medical countermeasures for public health emergencies.
Crossject
A Dijon-based pharmaceutical company specializing in needle-free injection systems for acute care and emergency medicine.
The details
The development plan, formalized under Modification 4 to contract number 75A50122C00031, focuses on the midazolam autoinjector technology. This device uses a needle-free system designed to deliver midazolam quickly in emergency settings, which is essential for stopping prolonged seizures. The consolidation plan incorporates rigorous validation of product stability to ensure the autoinjectors remain reliable throughout their shelf life in national stockpiles.
Timeline
September 23, 2026: Crossject and BARDA announced the updated clinical development plan.
June 21, 2030: The contract period of performance is scheduled to conclude.
Health Landscape
This effort reflects an ongoing shift to prioritize the inclusion of pediatric-specific data in the development of life-saving emergency medical devices. It marks a departure from historical practices where pediatric applications often lagged significantly behind adult approvals.
This development represents a step toward wider availability of emergency seizure care for children, which is a subject worth discussing with your pediatrician if you manage a family history of seizure disorders. Keep in mind that current care protocols remain the standard until these new devices receive regulatory approval.
The takeaway
The development of reliable, rapid-access emergency medication is evolving to better serve the specific needs of children. For those managing chronic conditions, continue to work with your physician to ensure you have an up-to-date, actionable seizure action plan in place today.
Further reading
Learn more about the latest developments in emergency care and Allergies.
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