Crossject and BARDA Expanded ZEPIZURE Development Plan

The partners have updated their clinical strategy and secured additional funding for pediatric emergency medication.

Updated on Sept. 23, 2026 in Allergies

Bold flat-color editorial illustration of a medical injector device in navy and cream, representing pharmaceutical regulatory development. — Crossject and BARDA have extended their clinical development contract through 2030, aligning the pediatric pathway for ZEPIZURE with FDA regulatory standards. AI Illustration. Upload story photo >

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Crossject and the Biomedical Advanced Research and Development Authority (BARDA) have consolidated their clinical development plan for the pediatric indication of ZEPIZURE. This update includes an extension of the contract period through June 2030 to better align with FDA guidance.

Why it matters

Aligning the pediatric development of ZEPIZURE with official FDA standards ensures that this emergency treatment meets regulatory requirements for U.S. preparedness. The move strengthens the path toward broader clinical availability for both adult and pediatric patients.

BARDA has provided an additional $4.7 million in non-dilutive funding, bringing the total program investment to $48.0 million. The agreement covers the acquisition of 306,000 adult and 54,000 pediatric ZENEO Midazolam autoinjectors.

The players

Crossject

A French pharmaceutical company headquartered in Dijon that specializes in the development of needle-free autoinjector technology.

Biomedical Advanced Research and Development Authority (BARDA)

A U.S. federal agency under the Department of Health and Human Services responsible for the development and procurement of medical countermeasures.

The details

The development plan was updated under Modification 4 to contract number 75A50122C00031 to include a validation campaign focused on long-term product inventory management. While the pediatric plan has been adjusted, the Emergency Use Authorization (EUA) pathway for the adult indication remains unchanged.

September 23, 2026: Crossject and BARDA announced the consolidated development plan.
June 21, 2030: The contract period of performance concludes.

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The Big Picture

This development represents a strategic expansion of the U.S. national medical countermeasure stockpile by diversifying available emergency medical inventory. The integration of pediatric-specific devices follows a pattern of increasing targeted preparedness for vulnerable demographic groups.

The expansion of this program aims to ensure that pediatric-specific emergency autoinjectors are available for U.S. emergency preparedness efforts. This work supports the long-term goal of providing rapid medical intervention options for both adult and pediatric populations.

The takeaway

The consolidation of this clinical plan demonstrates the federal government's commitment to refining medical readiness through long-term infrastructure and supply agreements. Future updates will focus on completing the stability and validation campaigns required for eventual deployment.