Alar Pharmaceuticals Announces First Patient Dosing in a Study of ALA-3000 (Extended-Release Ketamine Injection) for Treatment-Resistant Depression (TRD)

TAICHUNG, May 14, 2025 /PRNewswire/ -- Alar Pharmaceuticals Inc. (Alar, TPEx:6785), a clinical-stage pharmaceutical company dedicated to the development of long-acting injectables to treat CNS disorders, today announced the dosing of the first patient in the multiple ascending study of subcutaneous extended-release Ketamine (ALA-3000) for Treatment-Resistant Depression (TRD) in the US. This phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose study is planning to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of ALA-3000 Injection in addition to standard of care in TRD patients.

ALA-3000, developed by Alar Pharmaceuticals, is the first formulation of ketamine lasting over one week in the blood following single dose. It has been demonstrated in the animal model for more than one month of antidepressant effects. This innovative formulation aims to alleviate symptoms of TRD by delivering a stable, low level of ketamine. By doing so, it seeks to reduce common side effects associated with rapid-acting ketamine formulations, such as sedation, dissociation, dizziness, and anxiety.

Designed with patient safety, compliance, and convenience in mind, ALA-3000 is expected to minimize the need for frequent clinic visits and prolonged on-site monitoring. This approach not only enhances the safety and durability of treatment but also aims to diminish the overall healthcare burden.

"This first-in-human clinical trial of ALA-3000 marks a significant milestone in its development." said Yung-Shun Wen Ph.D., CEO of Alar. "This represents a novel treatment pattern, where prolonged exposure to low-level ketamine may further extend its antidepressant effects, providing patients with a more stable and longer-lasting therapeutic option."

"Beyond offering patients a new treatment option, the development of ALA-3000 sustained-release injection also holds promise in mitigating the global trend of increasing off-label ketamine abuse." said Charles Lin, Founder and Chairman of Alar.

For more information, please visit Alar's website at https://alarpharm.com/ and ClinicalTrials.gov for additional information. https://clinicaltrials.gov/study/NCT06965569

SOURCE Alar Pharmaceuticals Inc.