Study summary

The FDA turned down brexpiprazole with sertraline for PTSD

Brexpiprazole decision · Three randomized trials · FDA decision September 2025

What was tested

Brexpiprazole, an antipsychotic, started together with the antidepressant sertraline.

What they found

• The FDA said the application did not show substantial evidence that the combination works.
• Its advisory committee had voted 10 to 1 that effectiveness was not established.
• The trials gave conflicting results.

What it means

The only conventional pill combination close to approval for PTSD did not make it.