Name: LB-102 in Schizophrenia: Other product development or post-marketing obligations required by the FDA
Published: 2026-10-08T10:27:28-04:00

Product information and disease description Place of product in therapy Approaches to treatment

Other product development or post-marketing obligations required by the FDA

2 evidence topics · 2 sources

Trials the company expects to support approval

“Based on the design of this clinical trial, the results discussed below, and positive feedback from FDA as part of our end-of-Phase 2 interaction, we believe this Phase 2 trial may serve as one of two adequate well-controlled clinical trials of LB-102 required for approval.” (opens the source at this quote in a new tab)

Safety database the company anticipates the FDA will require

“In addition to our 6-week Phase 3 trial, the design of which we shared with the FDA as part of our end-of-Phase 2 interaction, we anticipate the FDA will require 1,500 patient exposures to support an approval in schizophrenia.” (opens the source at this quote in a new tab)
“We expect to accrue these patient exposures through the Phase 3 and long-term OLE trials, the supportive Phase 1 trials and trials in other indications.” (opens the source at this quote in a new tab)

“Concurrently with the Phase 3 NOVA-2 trial, we are enrolling an outpatient, open label trial (NOVA-3) to accrue the requisite safety population required to support NDA submission as well as other clinical trials and non-clinical studies typically required by FDA for an NDA approval.” (opens the source at this quote in a new tab)

Post-marketing requirements or commitments

Not applicable.