Drug Watch

PleoPharma secures $6.5M NIDA grant to advance phase 3 PP-01 trial, aiming to ease cannabis withdrawal and address untreated cannabis use disorder.

FDA signals clear IND path for PT00114, a first-in-class neuropeptide aiming to reset stress responses in patients with generalized anxiety disorder.

Real‑world inpatient use of xanomeline/trospium shows rapid awakening from negative symptoms in schizophrenia, with response predictors and striking case insights.

KINECT-PRO shows Ingrezza eases tardive dyskinesia movements and boosts daily function and quality of life, even across psychiatric diagnoses.

DT120 (lysergide) hits all endpoints in phase 3 GAD trial, cutting anxiety scores with a single dose.

FDA approves Takeda’s Orzeyful, first orexin agonist, improving wakefulness and reducing cataplexy in adults with narcolepsy type 1 in pivotal trials.

Check out the pipeline updates from July!

PMN310 shows strong 6‑month safety in early Alzheimer disease, with zero ARIA‑E and encouraging tau biomarker shifts before 2027 data.

New analysis shows COMP360 psilocybin sessions for PTSD stay mostly silent, with nondirective support boosting safety and autonomy.

Phase 2 ZEPHYR finds oral betovumeline combo reduces PANSS and improves cognition in acute schizophrenia, with generally mild side effects.

FDA clears Simtriyo, a first-in-class NDSRI and central nervous system stimulant for ADHD, offering new symptom and executive-function gains.

Review centanafadine ahead of the upcoming FDA decision on July 24.

FDA grants Fast Track to Acadia’s remlifanserin for Alzheimer disease psychosis, targeting hallucinations and delusions as RADIANT trial advances toward 2026 data.

Oral THC/CBD combo rapidly eases severe dementia agitation in phase 2 trial, with sustained 12-week benefit and similar safety to placebo.

FDA accepts AXS-12 NDA for cataplexy in narcolepsy after phase 3 shows fewer attacks, better wakefulness, and cognition; decision due May 2027.

New primate data show IV tau-silencing gene therapy cuts brain tau up to 75% with liver-sparing safety, clearing path for 2026 trial.

Phase 3 data show COMP360 psilocybin delivers rapid, lasting relief in treatment-resistant depression; FDA filing advances toward 2027 launch.

Open-label phase 2 trial tests IV Briumvi alongside antipsychotics for treatment-resistant schizophrenia, targeting B-cell depletion to improve symptoms and assess safety.

Phase 3b trial shows centanafadine eases adult ADHD and anxiety symptoms fast, with expected safety profile, as FDA review nears.

Track latest neuropsychiatry breakthroughs: phase 3 narcolepsy study launches, new depression and PTSD therapies advance, and FDA approvals reshape care.

Check out the pipeline updates from June!

Phase 2 IRIS finds ML-004 misses social communication goals in autism, but notably reduces irritability in teens.

FDA issues CRL for cytisinicline, citing manufacturing issues.

Phase 3 results show single-dose DT120 lysergide ODT delivers rapid, lasting relief in major depressive disorder with mild, transient adverse effects.

AbbVie’s short-acting psychedelic bretisilocin shows rapid MADRS drops in phase 2a MDD trials, hinting at scalable, supervised depression care.