Drug Watch

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.

Alkermes’ phase 2 Vibrance-2 shows alixorexton significantly boosts wakefulness and reduces daytime sleepiness in narcolepsy type 2, with benefits sustained.

New SLEEP 2026 data show orexin agonist oveporexton boosts cognition, daily function, and reduces microsleeps in narcolepsy type 1.

Check out new phase 2 dose-ranging study data evaluating alixorexton in patients with narcolepsy type 2.

New phase 3 data show oveporexton (TAK-861) boosts functioning and cognition, eases NT1 symptoms, and improves sleep

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!

The ASCp meeting spotlights a fast-acting psychedelic for postpartum depression, vasopressin-targeting drugs, and ketamine’s promise for Parkinson symptoms.

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!

Auvelity is now approved for the treatment of Alzheimer disease agitation. Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP, weighs in.

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

FDA approves Axsome’s AXS-05 for Alzheimer’s agitation, backed by multiple trials.

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.

DT120, a pharmaceutical-grade formulation of LSD, shows rapid, lasting anxiety relief—single dose, no therapy—with 48% remission at 12 weeks.

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.