Drug Watch

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.

Explore 2026’s fast-moving psych med pipeline: new Alzheimer agitation option, potential novel ADHD therapy, and promising psilocybin for depression.

Phase 2 trial shows elunetirom rapidly eases bipolar depression symptoms with strong response, good tolerability, and FDA Fast Track momentum.

FDA issues CRL for CTx-1301 in ADHD.

Check out the pipeline updates from May!

Synendos launches a phase 2 trial of SYT-510, a first-in-class endocannabinoid modulator, aiming to ease generalized anxiety symptoms with improved safety and adherence.

Phase 2 MINDFuL data show XPro trends toward cognitive and biomarker gains in inflammation-defined mild Alzheimer disease, with no ARIA, guiding phase 3 plans.

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.