Trial intelligence / Profile preview

Adjunctive NBI-1065845 for major depressive disorder

2024-519418-29-00Phase 3Authorised

Sponsor
Neurocrine Biosciences
Start
Sep 2025
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Irreversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules
Countries
4
01

Overview

Phase 3, randomised, double-blind trial in major depressive disorder (MDD) and persistent depressive disorder (PDD) comparing NBI-1065845 adjunctive treatment with Placebo adjunctive treatment (2 arms). Primary endpoint: Change from baseline in total MADRS score at Day 56. Planned start Sep 2025; status: authorised.

02

Drugs

osavampator
03

Conditions

major depressive disorder (MDD)persistent depressive disorder (PDD)

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