428Pharma
Pioneering Depression Relapse Prevention
Developing the world’s first treatment to prevent relapse in depression
The Unmet Need —
Preventing Relapse in Depression
[Editing: Intro, Example: Relapse in Major Depressive Disorder (MDD) is common and progressive, significantly increasing the risk of treatment resistance and severe outcomes. Effective relapse prevention remains a major unmet need in mental health care.]
1 in 2 patients relapse
after their first episode of depression.
Risk increases with each episode
reaching 70% after the first new episode and 90% after the second and third.
Up to 30% of TRD patients
attempt suicide during their lifetime. Once a patient relapses 2x or more, they are classified as TRD, which is much harder to treat.
+56% increase in suicides
among young people (ages 10–24) between 2007 and 2017 undermines the mental health crisis.
At 428 Pharma
We believe
Prevention of Relapse is the most powerful form of treatment. Relapse prevention can stop depression from progressing to treatment resistant and ultimately, help save lives. ​​
Today, no approved therapies exist that effectively prevent relapse in Major Depressive Disorder (MDD).
428 Pharma is changing that.
Our Product
Escitalopram LAI
(Long-Acting Injectable)
428 Pharma develops the world's first LAI for prevention of relapse in MDD with a potential time to market by 2029.
First SSRI Depot
First long-acting injectable for a SSRI in vast depression market estimated at $15.8bn in 2025.
Fast FDA Pathway
505(b)(2) truncated development with LOE 2046.
Accelerated pathway with option to PK-only approval pathway under FDA.
Early Licensing Potential
Opportunity to out-license end of phase I​.