Drug Watch

FDA clears MIND1 trial testing NRX-101 plus robotic TMS to curb suicidality in treatment-resistant depression, with military-focused sites.

New analysis ranks lumateperone top for adjunctive MDD symptom relief, with minimal weight gain vs other atypical antipsychotics.

Check out the pipeline updates from April!

The FDA has approved Auvelity, an oral NMDA/sigma-1 therapy, offering a new option to curb Alzheimer disease agitation and ease caregiver burden.

New US patent backs Denovo’s ANK3 biomarker guiding DB104 for treatment‑resistant depression, highlighting promising efficacy in selected patients.

Adial seeks FDA priority voucher to speed AD04 review, a biomarker-guided therapy aiming to curb heavy drinking in alcohol use disorder.

FDA expands Caplyta label to prevent schizophrenia relapse, cutting risk 63% and showing weight-neutral tolerability for sustained long-term stability.

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

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.