Johnson & Johnson depression drug fails Phase 2 goal

Johnson & Johnson and its partner Contineum Therapeutics announced that JNJ-5120/PIPE-307 failed to reach its primary efficacy endpoint in the Phase 2 MOONLIGHT-1 study for major depressive disorder. Johnson & Johnson is advancing the drug under a global license and development agreement.

The MOONLIGHT-1 trial evaluated the drug as a monotherapy in 107 adults. Its primary endpoint measured the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo. The drug targets the muscarinic M1 receptor and was tested as a potential rapid-acting therapy, but it did not meet the required threshold.

Contineum stated that the drug was well tolerated and showed no new safety signals during the study. This outcome follows an earlier setback in 2025, when a study evaluating PIPE-307 in patients with relapsing-remitting multiple sclerosis also failed to show a benefit on its primary efficacy measure.

Johnson & Johnson has not announced an end to the program. The company is continuing to analyze the broader dataset, including prespecified exploratory endpoints, before deciding on its next steps.