Janssen Halts Phase III Development of Aticaprant for Major Depressive Disorder Due to Insufficient Efficacy

On March 7, 2025, a striking announcement spread across the biotech industry: Johnson & Johnson halted its Phase 3 program for the investigational drug aticaprant in treating Major Depressive Disorder (MDD) due to "insufficient efficacy." This decision not only cast a shadow over Johnson & Johnson's R&D path but also sparked widespread attention and reflection within the biotech sector.

Previously, Neumora's similar drug navacaprant failed in a Phase 3 MDD trial in January. Earlier this week, after evaluating the data set, Neumora halted a trial of the candidate drug and suspended two late-stage studies, with the data being worse than analysts had estimated based on the preliminary failure results.

Aticaprant and Navacaprant are both oral opioid κ receptor antagonists and are strong competitors in the field of depression treatment.Neumora once cited the Phase 2 data of aticaprant in an attempt to prove the effectiveness of its mechanism of action.Believes that the failure of its own drug trial is just an accident. But after the stock market closed on Thursday, Johnson & Johnson announced the halt of the Phase 3 project due to aticaprant's poor efficacy in the target patient population, which undoubtedly dealt a heavy blow to Neumora's perspective.

Notably, Johnson & Johnson has not completely abandoned aticaprant. The company noted that aticaprant has good safety and tolerability, and it will explore its development opportunities in other unmet medical needs areas in the future.

Previously, Johnson & Johnson predicted at the end of 2023 that the annual peak sales of aticaprant could reach between $1 billion and $5 billion. This data is part of Johnson & Johnson's vision to become a leader in the neuroscience field by 2030. To accelerate the realization of this goal, in January this year, Johnson & Johnson spent a whopping $14.6 billion to acquire Intra-Cellular Therapies, obtaining Caplyta, a Phase 3 successful drug for treating major depressive disorder.

In January this year, during Johnson & Johnson's earnings call, Dr. Alexandria Hammond, an analyst at Wolfe Research, asked whether the company’s acquisition of Caplyta would lead to a reduction in the R&D prioritization of seltorexant and aticaprant. Dr. John Reed, Executive Vice President of Innovative Medicine Development at Johnson & Johnson, clearly stated that it would not, emphasizing the need for drugs with different mechanisms of action to address various patient subgroups.

The termination of the aticaprant project, while impacting Johnson & Johnson's short-term plans in the MDD treatment field, does not deter the company from actively pursuing new breakthroughs in neuroscience in the long run. Whether aticaprant can find new potential in other areas and whether Johnson & Johnson’s neuroscience strategy will advance smoothly remain developments worth monitoring.