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Q2 2025 Recap: Psychiatry Updates—TRD Breakthroughs, FDA News, Latest Podcast Episodes
This Q2 psychiatry recaps promising data of COMP360 for treatment-resistant depression, the expansion of clozapine access, and experts weighing in on new data and ethical debates.
Before Q2, HCPLive spoke with Steve Levine, MD, from Compass Pathways, for a Q1 recap and a look ahead at what was to come in psychiatry. Now that the quarter has wrapped, we’re revisiting those expectations.
Back in April, Levine highlighted 2 key studies to watch: Compass Pathways’ topline results for COMP360 psilocybin and Beckley Psychtech’s intranasal 5-MeO-DMT (BPL-003), both for TRD. Compass delivered on June 23, publishing phase 3 data from COMP005. A single 25 mg dose of COMP360 led to a significant reduction in depression severity at 6 weeks.
Beckley followed with their phase 2b data on July 1. BPL-003 met its primary and secondary endpoints, showing rapid, robust antidepressant effects after a single dose.1 Patients on 8 mg and 12 mg had meaningful symptom reduction by week 8, and most were ready for discharge within 90 minutes, fitting well within the 2-hour in-clinic model.
Along with the promising COMP360 data, this recap spotlights the unsuccessful phase 3 ARISE trial for xanomeline-trospium (Cobenfy) as an adjunctive schizophrenia treatment, an interview with John Kane, MD, on promising LB-102 data, and new podcast episodes of Medical Ethics Unpacked and the Gus Alva Perspective.
FDA Updates
FDA Officially Eliminates Clozapine REMS
On June 13, 2025, the US Food and Drug Administration (FDA) officially eliminated the clozapine REMS program to improve access to this effective treatment for schizophrenia. Although monitoring for severe neutropenia remains recommended, prescribers now have sole responsibility for determining clozapine’s use. In response, the Schizophrenia & Psychosis Action Alliance and American Association of Psychiatric Pharmacists are launching A New Era in Clozapine Management this fall to support safe, stigma-free prescribing.
What's Moving in the Pipeline
Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial
Compass Pathways announced positive topline results from its pivotal phase 3 COMP005 trial on June 23. A single 25 mg dose of COMP360 led to significant reductions in depression severity at 6 weeks among patients with TRD, meeting the primary endpoint. No major safety concerns were reported. The company plans to share 26-week follow-up data once its companion trial (COMP006) progresses.
Cobenfy Falls Short in Phase 3 ARISE Trial as Adjunctive Schizophrenia Therapy
In the phase 3 ARISE trial, xanomeline and trospium chloride (Cobenfy) did not achieve a statistically significant benefit as an adjunctive schizophrenia treatment. The 6-week study showed only a modest 2-point PANSS score difference versus placebo. However, subgroup analysis suggested Cobenfy may be more effective when paired with non-risperidone antipsychotics. Despite the missed endpoint, the safety profile remained favorable, and further research is encouraged.
Interview With John Kane, MD, on LB-102
LB-102 Significantly Improves Disease Severity in Acute Schizophrenia, with John Kane, MD
LB-102, a novel oral benzamide antipsychotic, demonstrated significant improvement in disease severity in the phase 2 NOVA trial. Doses of 50–100 mg led to meaningful CGI-S score reductions and positive effects on PANSS scores, with minimal weight gain and extrapyramidal symptoms. Lead investigator John Kane, MD, noted its potential to address unmet needs, particularly for negative symptoms and maintenance therapy.
Gus Alva Perspective
Launched May 16, 2025, The Gus Alva Perspective is a clinician-focused podcast hosted by psychiatrist Gus Alva, MD, medical director of ATP Research. With new episodes twice monthly, the show offers expert commentary on treatment advances and exclusive coverage leading up to the Southern California Psychiatry Meeting.
Featured Episodes:
The Gus Alva Perspective: SoCal Psych Preview—Schizophrenia Updates, with Jonathan Meyer, MD
The Gus Alva Perspective: SoCal Psych Preview—Tardive Dyskinesia, with Jonathan Meyer, MD
Medical Ethics Unpacked
Medical Ethics Unpacked: Shifting Vaccine Regulation and Policy, with Jason Schwartz, PhD
Jason Schwartz, PhD, of Yale, joins hosts Dominic Sisti, PhD, and Steve Levine, MD, to discuss the ethics of vaccine regulation. They examine how COVID-19 reshaped vaccine trust, amplified political divisions, and exposed vulnerabilities in public health infrastructure. The conversation addresses tensions between individual rights and collective health, misinformation’s impact, and the controversial replacement of ACIP members by HHS Secretary Robert F. Kennedy Jr.
Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies
Amy McGuire, JD, PhD, from Baylor College of Medicine, joins Sisti and Levine to explore the unique ethical issues in psychedelic therapy, particularly informed consent, cultural integration, and altered states of consciousness. The FDA’s recent rejection of MDMA-assisted therapy for PTSD has heightened debate over how to responsibly introduce these treatments into Western clinical practice.
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