December in Review: Updates on the Psychiatric Treatment Pipeline

Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

Delay on Cobenfy Alzheimer Disease Psychosis Data Following Phase 3 Study “Irregularities,” New Patients Enrolled

Bristol Myers Squibb announced that it will enroll additional patients in the ADEPT-2 study—a phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of xanomeline/trospium (Cobenfy) in participants with psychosis associated with Alzheimer disease dementia. Following a thorough blinded review of the ADEPT-2 study data, BMS identified irregularities due to clinical trial execution at a limited number of study sites. After reviewing these findings and before a database lock, BMS decided to exclude the patient data from those select sites from the primary analysis. Following this analysis, the DMC recommended the study should continue and enroll additional patients to the original target study population. Based on this recommendation, BMS will continue patient enrollment and advance the program as advised by the DMC, while remaining blinded to study data.

Psychedelic PSX-001 for Generalized Anxiety Disorder: A Conversation With Lou Barbato, MD

Earlier this year, Incannex Healthcare shared positive data from a phase 2 clinical trial of PSX-001 (formerly known as Psi-GAD), a psilocybin-assisted psychotherapy treatment for generalized anxiety disorder (GAD). Investigators found statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing PSX-001’s potential as a potential therapy for patients with moderate to severe GAD. Psychiatric Times sat down with Lou Barbato, MD, the chief medical officer of Incannex, to discuss this news and the overall potential of psychedelics in treating mental health disorders.

Favorable Profile Data On MK-2214 for Treatment of Alzheimer Disease

Merck pharmaceutical company shared new data on MK-2214 for treatment of Alzheimer disease at the 2025 Clinical Trials on Alzheimer’s Disease conference, December 1-4 in San Diego, California. Phase 1 trials on the drug showed a favorable profile to slow the progression of Alzheimer disease.

Evenamide for Treatment-Resistant Schizophrenia: Initiation of ENIGMA-TRS 2 Phase 3 Clinical Study

Newron Pharmaceuticals today announced the initiation of its ENIGMA-TRS 2 phase 3 clinical study in the US, following approvals from the US Food and Drug Administration and the Institutional Review Board. The first site to initiate the study will be the Semel Translational Research Center for Neuropsychiatry, University of California, Los Angeles. ENIGMA-TRS 2 is a phase 3, global, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared with placebo, in patients with treatment-resistant schizophrenia.

NDA Submission: Olanzapine Extended-Release Injectable Suspension for Treatment of Schizophrenia

Teva Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of adults with schizophrenia. The NDA for olanzapine long-acting injectable is based on results from the phase 3 SOLARIS trial, including week 56 results studying its efficacy, safety, and tolerability in participants aged 18 to 64 with schizophrenia.

FDA Accepts NDA for TRN-257 for Treatment of Narcolepsy and Idiopathic Hypersomnia

Tris Pharma today announced that the US Food and Drug Administration has accepted the New Drug Application for TRN-257—a controlled-release, low-sodium oxybate product—for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy and the treatment of idiopathic hypersomnia in adults. When compared with other oxybate treatment options, TRN-257 is the lowest sodium (80 mg sodium for 9 g dose), once-nightly treatment currently in development for adults with narcolepsy and idiopathic hypersomnia.

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