Bringing the world's first treatment to prevent relapse in depression
428 Pharma is a Netherlands-based pharma company pioneering the development of the world’s first Long-Acting Injection (LAI) for the treatment of Major Depressive Disorder (MDD).
Our approach leverages the FDA’s 505(b)(2) regulatory pathway to accelerate development timelines, reduce costs, and bring innovative mental health therapies to patients faster.
With patents granted until at least 2043 and a potential to reach $4B in peak sales, our lead program has the potential to transform the standard of care in depression treatment.
Our Story
Our mission is to redefine the treatment experience for patients with Major Depressive Disorder by delivering therapies that are more effective, more convenient, and more consistent than existing oral medications. We aim to empower patients, reduce relapse rates, and improve adherence — ultimately transforming mental health outcomes worldwide.
We envision a future where mental health treatments are accessible, predictable, and stigma-free, supported by advanced drug delivery systems that enhance patient quality of life and reduce the burden on healthcare systems.
Our Approach
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Innovative drug delivery using LAI technology to enhance psychiatric care adherence.
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Speedy FDA 505(b)(2) pathway adoption for efficient regulatory processes
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Embracing U.S. manufacturing for global commercialization readiness.
Meet The Team
