Drug Watch

The FDA accepts Teva’s once-monthly olanzapine injection for schizophrenia, promising steadier adherence without mandatory 3-hour monitoring.

FDA feedback for CYC-126: anesthetic therapy with live EEG guidance aims to deliver precise relief for treatment-resistant depression.

IV DMT psychedelic SPL026 reduces major depression in phase 2a.

Phase 3 trial shows COMP360 psilocybin rapidly reduces treatment-resistant depression symptoms with durable effects and good safety, as Compass moves toward FDA review.

FDA reviews INmune Bio’s biomarker-enriched Phase 2b/3 plan for XPro1595.

Data and Safety Monitoring Board finds no safety issues for buntanetap at 6 months, keeping Annovis’ phase 3 early Alzheimer disease trial on track as enrollment progresses.

A new liquid stimulant option promises up to 14-hour ADHD symptom control and flexible dosing for adults and kids who struggle with capsule medication.

Denovo teams with Orygen to test DB103, a glutamate-targeting therapy, in a phase 2 youth trial for early psychosis.

FDA grants priority review to Takeda’s orexin agonist oveporexton, promising phase 3 gains in wakefulness and cataplexy for narcolepsy type 1.

Cognition extends zervimesine expanded access for Lewy body dementia, adding months of dosing and easier local monitoring.

Preclinical mGlu7 negative allosteric modulator ADX71743 disrupts fear-memory reconsolidation.

Check out the pipeline updates from January!

The FDA has accepted for priority review an NDA for Otsuka's centanafadine, a novel ADHD treatment.

Neurocrine Biosciences launches a phase 2 trial for NBI-1065890.

LB Pharmaceuticals initiates a phase 2 trial for LB-102, a promising treatment for bipolar depression, aiming to address unmet needs in mood disorders.

LPCN 1154 shows promise as a rapid, at-home treatment for postpartum depression, with favorable safety results in ongoing phase 3 trials.

BioXcel Therapeutics submits an sNDA to the FDA for Igalmi to treat agitation in bipolar disorder and schizophrenia at home.

Seltorexant shows promise as a safe adjunctive treatment for patients with major depressive disorder and insomnia symptoms, with fewer weight changes than quetiapine XR.

New data reveals Caplyta significantly improves remission rates in adults with major depressive disorder, offering hope for lasting relief from symptoms.

Centanafadine demonstrates promising effects on ADHD symptoms, enhancing key neurotransmitters without increasing psychomotor activity, according to poster data.

Axsome Therapeutics begins a pivotal trial for AXS-14, aiming to improve fibromyalgia management and address significant patient needs.

New data reveals valbenazine (Ingrezza) shows significantly higher VMAT2 target occupancy than deutetrabenazine (Austedo XR).

Scienture's Rezenopy, the highest-dose naloxone nasal spray approved by the FDA, gains patent protection.

FDA removes suicidal ideation warnings from GLP-1 RA medications, highlighting their potential benefits in weight loss and mental health treatment.