Drug Watch

FDA accelerates psychedelic drug development to advance agents for TRD, PTSD, and AUD.

Definium’s CMO says FDA talks stay aligned with their plans for advancing DT120 ODT for the treatment of depression, anxiety, and now PTSD.

AXS-05 for Alzheimer disease agitation nears FDA decision date.

Two-dose oral R‑MDMA, EMP-01, cuts social anxiety symptoms and real‑world avoidance in phase 2a study, with strong responder rates and good tolerability.

Vibrance-1 phase 2 results show alixorexton improves narcolepsy type 1 severity, cognition, and fatigue for 13 weeks with good tolerability.

Data suggest PBFT02 therapy boosts progranulin and slows neurodegeneration markers in early FTD.

A new US-based grant program seeks to create training content for health care providers who want to be able to deliver investigational COMP360 psilocybin treatment.

BPL-003 phase 2a part 2 results show reductions in depression symptoms.

A new US Department of War backed phase 2a study will test BXCL501's efficacy in easing acute stress reactions and preventing PTSD.

Experts share how roluperidone provides a new opportunity in the schizophrenia treatment landscape.

Early MRS data show AL001 delivers lithium effects across the brain while sparing glutamate, hinting at better tolerability than lithium carbonate.

A novel form of agomelatine shows positive initial results.

Phase 2 trial of oveporexton for narcolepsy type 1 finds improvement on measures of cognition, in addition to previously demonstrated improved hallmark symptom of nighttime wakefulness.

Lipocine's oral brexanolone (LPCN 1154) for the treatment of postpartum depression failed to meet the primary endpoint in a phase 3 placebo-controlled trial.

New initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 and type 2.

Q1 psychiatric pipeline shifts: wins, setbacks, and standout trials in depression, schizophrenia, Alzheimer disease, and narcolepsy—what to watch next.

Check out the pipeline updates from March!

Further data shared on LB-102 for schizophrenia.

A panel of experts presented new consensus recommendations focused on the screening, diagnosis, and treatment of tardive dyskinesia among older adults in long-term care settings.

Tazbentetol interim results show improvement in schizophrenia symptoms.

LB Pharmaceuticals has initiated the pivotal phase 3 NOVA-2 trial evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia.

AD/PD 2026 highlights oral blarcamesine preserving brain volume and IV lecanemab sustaining use while clearing amyloid-beta.

Intranasal BPL-003 shows rapid, sustained depression relief in treatment-resistant patients.

Phase 2 study tests AL001 brain-targeted lithium in bipolar I, aiming to cut toxicity and monitoring via advanced MRI/MRS imaging.