Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo

Phase 2 Completed 204 enrolled Neumora Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A proof of concept (POC) study evaluating the impact of NMRA-335140 (BTRX-335140) relative to placebo on symptoms of major depressive disorder (MDD) in adult participants with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

Timeline

Start: 2020-01-03
Primary completion: 2022-04-08
Completion: 2022-06-23

Outcome

Missed primary endpoint

registry analysis (other test); NMRA-335140 vs Placebo; p = 0.121; Least square mean difference -1.7 (95% CI -3.8 to 0.4) NCT04221230 ↗

paper Although the primary endpoint was not met in the efficacy population, which included participants with mild depression, PMID 40199329 ↗

Publications

Mathew SJ, Cutler AJ, Visitacion NC, Gold M, Yuan J, Aurora B. Navacaprant, a Novel and Highly Selective Kappa Opioid Receptor Antagonist, in Adults With Major Depressive Disorder: A Randomized, Double-Blind Phase 2 Clinical Trial. J Clin Psychopharmacol. 2025 May-Jun 01;45(3):267-276. doi: 10.1097/JCP.0000000000001967. Epub 2025 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NMRA-335140	Small molecule	—	Oral