Drug intelligence / Profile preview

Lu AF09535

Development stage
Unknown
Lead developer
Lundbeck
Modality
Small Molecules
Administration
Oral
01

Overview

Lu AF09535 is an investigational small molecule new chemical entity (NCE) developed by Lundbeck for the treatment of mood disorders. In a Phase I first-in-man clinical trial, the compound demonstrated unexpectedly low systemic exposure in humans. Subsequent investigations using 14C-microdose accelerator mass spectrometry (AMS) revealed that this was caused by extensive metabolism through a human-specific pathway not present in preclinical species. The specific molecular target and chemical structure of Lu AF09535 remain proprietary and have not been publicly disclosed.

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