Drug Watch

Study results suggest the potential for a scalable, single-dose treatment approach.

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints of a new phase 3 study.

Learn more about the latest data on KarXT, which is posed to be the first new pharmacological treatment for schizophrenia.

A supplemental new drug application was submitted for the combination of brexpiprazole and sertraline in the treatment of PTSD in adults.

Lykos Therapeutics recently received priority review of MDMA-assisted therapy for patients with PTSD. Check out the latest research update here!

This alters the course of developer Eisai's regulatory submission plans for lecanemab in the treatment of early Alzheimer disease.

“The selectivity of NBI-1070770 for the NMDA NR2B receptor may benefit patients with moderate to severe depression.”

New phase 2 study initiated to determine the potential of ALTO-203 as an antidepressant in patients with major depressive disorder and anhedonia.

The atypical antipsychotic was approved for the acute treatment of schizophrenia in 2009.

The FDA has cleared the first prescription digital therapeutic for major depressive disorder, Rejoyn.

Vistagen has enrolled the first participant in the PALISADE-3 phase 3 trial of fasedienol for the treatment of social anxiety disorder.

This treatment is now the first and only TMS treatment that is FDA-cleared for this patient population.

The short-acting psychedelic, BPL-003, resulted in rapid, durable depression symptom reduction in patients with TRD.

The treatment significantly reduced the frequency of cataplexy attacks in patients with narcolepsy compared with placebo.

The trial aims to investigate the positive, negative, and cognitive domains of schizophrenia.

Pimavanserin failed to achieve the primary efficacy endpoint of control of negative symptoms in patients with schizophrenia in the ADVANCE-2 trial. Acadia Pharmaceuticals will not pursue further research.

New research on transcranial direct current stimulation effectiveness in treating major depressive disorder.

Alzheimer disease treatment donanemab will be delayed as the FDA plans to convene a committee meeting to evaluate the phase 3 Trailblazer-Alz 2 trial.

The US Food and Drug Administration has granted breakthrough designation to MindMed’s lysergide d-tartrate program (MM-120) for the treatment of generalized anxiety disorder.

The therapy is the first self-neuromodulation device for PTSD approved by the US Food and Drug Administration.

This trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of VLS-01 compared with intravenous DMT for treatment-resistant depression.

The CRL cited several areas for clinical improvement necessary for future approval of the treatment.

Elena Koundourakis, the head of the Orexin Franchise Development and Portfolio Strategy at Takeda, shares her thoughts on the recent positive topline results from a phase 2 trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.

AVP-786, a drug to treat agitation associated with Alzheimer disease dementia, failed to meet the primary efficacy endpoint in a phase 3 clinical trial.

The treatment's PDUFA date is set for August 11, 2024.