Drug Watch

The FDA has cleared the IND application for MIRA Pharmaceuticals' Ketamir-2, a promising oral treatment for neuropathic pain, which has shown superior efficacy and safety in preclinical studies.

Cognition Therapeutics reveals promising phase 2 results for zervimesine in treating dementia with Lewy bodies and Alzheimer disease at AAIC 2025.

Cingulate secures a $4.3 million FDA fee waiver for its innovative ADHD treatment, CTx-1301, enhancing patient care with extended efficacy.

Roche unveils promising Alzheimer disease treatments and diagnostic tools, including trontinemab and the Elecsys pTau217 blood test, at the AAIC conference.

Apnimed reveals promising results for AD109, a groundbreaking oral treatment for obstructive sleep apnea.

Positive phase 2 results show that treatment with alixorexton led to statistically significant and dose-dependent improvements in sleep latency among patients with narcolepsy type 1.

BioXcel Therapeutics has submitted an pre-sNDA meeting package for Igalmi's outpatient use, aiming to enhance treatment options for agitation in bipolar disorders and schizophrenia.

The FDA advisory committee votes against brexpiprazole plus sertraline for PTSD, citing insufficient efficacy despite some positive trial results.

Seaport Therapeutics initiates a pivotal study for GlyphAllo, a potential breakthrough treatment for major depressive disorder, with or without anxious stress.

FDA reviewers raise concerns over Rexulti's efficacy for PTSD, highlighting discordant study results ahead of the advisory committee meeting.

The FDA advisory committee will review brexpiprazole for PTSD treatment, which could offer new hope after years without new options.

Transcend Therapeutic announces breakthrough therapy designation for TSND-201 for treating PTSD.

Johnson & Johnson has submitted an sNDA for Caplyta, showcasing significant relapse prevention in schizophrenia.

What disease states are most prominently featured in recent research? Learn more in this exclusive article.

New clinical trial results reveal BPL-003's rapid and durable antidepressant effects, paving the way for innovative treatments in treatment-resistant depression.

The FDA will update ADHD medication labels, warning of weight loss risks in children under 6, urging careful monitoring by health care professionals.

Check out the pipeline updates from June!

Alto Neuroscience's ALTO-203 trial reveals mixed results, highlighting potential biomarkers for targeted depression treatment despite missing primary efficacy goals.

Compass Pathways reports significant progress in psilocybin research, showing promise for treatment-resistant depression in a pivotal phase 3 trial.

NRx Pharmaceuticals advances NRX-100, a preservative-free ketamine, through a fast-tracked FDA review for treating suicidal depression and PTSD.

Ecopipam shows promise as a safe, effective treatment for Tourette syndrome in children and adolescents, significantly reducing tic severity and improving quality of life.

The FDA's removal of clozapine REMS enhances access to treatment, while new educational initiatives empower clinicians to improve patient care.

Check out the pipeline updates from May!

Cariprazine shows promise as a long-term adjunctive treatment for anhedonia in major depressive disorder, according to new poster data presented at the ASCP Annual Meeting.

Neurocrine Biosciences reveals promising phase 2 results for NBI-1117568, a novel treatment for schizophrenia, showing significant symptom improvement over placebo.

Promising results from a phase 2 study of CPL'36, a novel PDE10A inhibitor, for acute schizophrenia exacerbation was presented at the APA annual meeting.

New analyses reveal valbenazine (Ingrezza) significantly enhances quality of life and functional outcomes for patients with tardive dyskinesia, supporting its long-term efficacy.

Newron Pharmaceuticals launches pivotal ENIGMA-TRS trials for evenamide, targeting treatment-resistant schizophrenia with promising efficacy and safety outcomes.

Adial Pharmaceuticals advances its treatment for alcohol use disorder, AD04, with FDA meetings and promising genetic insights for targeted therapy.

NRx Pharmaceuticals secures FDA fee waiver for NRX-100, a preservative-free ketamine aimed at treating suicidal depression, enhancing accessibility for patients.