HQ Team
March 7, 2025: Johnson & Johnson is discontinuing the Phase 3 VENTURA clinical trial of its experimental depression drug aticaprant after the therapy failed to demonstrate sufficient efficacy as an add-on treatment for adults with major depressive disorder (MDD).
The drug was deemed safe and well-tolerated, but the company has decided to halt its development and explore alternative applications for it. The decision underscores challenges in advancing novel depression therapies.
Aticaprant setback
Aticaprant, a selective kappa opioid receptor antagonist, was studied as a supplemental treatment for patients inadequately helped by standard antidepressants. Despite promising early-phase data, the Phase 3 trial confirmed it did not meet efficacy endpoints. Full results will be presented at a future medical conference. J&J emphasized that no new safety risks were identified, leaving the door open to repurpose the drug for other conditions, though specifics were not disclosed.
J&J’s depression treatment pipeline
Johnson & Johnson remains a key player in mental health innovation. Its FDA-approved nasal spray Spravato (esketamine), developed for treatment-resistant depression, has been a flagship product, generating $1.4 billion in 2023 sales. Spravato’s success has positioned J&J as a leader in rapid-acting antidepressants, though its high cost and administration requirements (in-clinic dosing) have raised questions about accessibility.
The company is also advancing other depression-related therapies, including Pimavanserin, which is an investigational drug for depressive symptoms in Alzheimer’s disease.
Strategic moves in neuroscience
With 21 million U.S. adults experiencing MDD annually—and 30% resistant to existing treatments—the need for innovative therapies remains critical. While aticaprant’s MDD journey ends, its safety profile may offer a pathway for conditions like chronic pain or substance use disorders, areas where kappa opioid mechanisms are being explored.
J&J recently announced plans to acquire Intra-Cellular Therapies for 462 million in 2023. Analysts view the acquisition as a bid to diversify J&J’s neuroscience portfolio amid patent cliffs for legacy drugs like schizophrenia treatment Invega.
Financial outlook
Despite the aticaprant setback, J&J reaffirmed its commitment to deliver 5-7% compound annual growth (CAGR) in its Innovative Medicine division through 2025. The company aims to become the global leader in neuroscience, competing with rivals such as AbbVie and Roche. However, the depression drug trial halt reflects broader industry struggles; over 60% of late-stage CNS drug candidates fail due to efficacy challenges.
