Drug Watch

Early trial shows investigational orexin-2 agonist ALKS 7290 improves adult ADHD symptoms in 14 days, with tolerable safety, paving way for phase 2.

Open-label extension data show fasedienol appears well tolerated and steadily improves social anxiety scores with as-needed intranasal use, as Vistagen plans FDA discussions.

Helus Pharma advances oral deuterated psilocin HLP003 for MDD, detailing new efficacy and safety analyses plus ongoing phase 3 PARADIGM trial updates.

Caplyta phase 3 data show rapid, significant mania symptom relief in bipolar I by day 3, sustained to week 3, with tolerable adverse effects.

Medicare claims show pimavanserin in Parkinson psychosis nursing homes links to fewer falls and recurrent falls than quetiapine or other antipsychotics.

New real-world studies show Vraylar boosts depression relief, functioning, and quality of life in MDD and bipolar I patients beyond clinical trials.

Phase 3 BLOOM tests 48-hour at-home oral brexanolone for rapid postpartum depression relief, with tighter monitoring after prior trial issues.

Phase 2 MOONLIGHT-1 shows JNJ-5120/PIPE-307 misses day‑5 MADRS improvement in MDD, yet remains well tolerated as J&J reviews next steps.

Single-dose DT120 ODT delivers rapid, sustained anxiety relief in phase 3 GAD trial, supporting FDA breakthrough path and NDA plans.

Phase 3 NEJM data show oveporexton improves wakefulness, reduces cataplexy, and boosts quality of life in narcolepsy type 1, with manageable adverse effects.

Phase 1 driving simulation finds bedtime GlyphAllo for major depressive disorder shows no next-morning driving impairment, while advancing allopregnanolone-based oral treatment development.

Psychedelic psilocybin therapy shows year-long relief in treatment-resistant depression, with strong response rates and stable safety.

FDA boosts DT120 lysergide ODT after phase 3 shows lasting depression relief; psychedelic tablet also advances for anxiety and other brain disorders.

A target trial emulation of more than 1.5 million matched adults ties GLP-1 RA initiation to lower mortality and cardiovascular events in serious mental illness.

BioVie completes treatment visits in a phase 2 long COVID trial of bezisterim targeting brain fog and fatigue, with topline results expected September 2026.

Check out our pipeline updates from August!

Axsome launches SUMMIT phase 3 testing AXS-05 to help adults quit smoking, comparing it with bupropion and placebo over 12 weeks.

Clearmind patents MDMA plus PEA combo aiming to boost PTSD, anxiety and eating-disorder therapy as FDA issues new psychedelic trial guidance.

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!