- By reducing dissociation and sedation risk, ALA-3000 may eliminate the =2-hour post-dose monitoring requirement, reducing clinic operating costs, improving patient throughput, and supporting a more cost-effective and reimbursement-aligned treatment model.
TAICHUNG, April 6, 2026 /PRNewswire/ -- Alar Pharmaceuticals Inc. (Alar, TPEx:6785), a clinical-stage biopharmaceutical company focused on developing long-acting injectables (LAIs), today announced the positive results from its phase 1 clinical study of ALA-3000, a proprietary long-acting, sustained-release ketamine injection for treatment-resistant depression (TRD). This randomized, double-blind, placebo-controlled, multiple-dose first-in-human study evaluated the subcutaneous (SC) administration of ALA-3000 in combination with a standard-of-care oral antidepressant in patients with TRD.
ALA-3000 met its primary endpoint, demonstrating a favorable safety and tolerability profile. The study further characterized a sustained-release pharmacokinetic profile of ketamine following SC administrations of ALA-3000 and showed clinically meaningful improvements across exploratory efficacy endpoints supporting continued clinical development.
In the study, patients received two SC injections of ALA-3000 (150 mg or 250 mg) or placebo administered one week apart, alongside a daily oral antidepressant. Treatment-related adverse events (AEs) were mild to moderate in severity. The most commonly related AEs observed across both active and placebo groups included injection site reactions, headache, and diarrhea, all of which were transient and resolvable. Notably, no subjects discontinued or withdrew from the study due to AEs or any other reasons. No clinically meaningful safety concerns were identified, including no blood pressure elevations or signals related to abuse potential or urinary AEs. Crucially, no dissociation, sedation, or psychosis-like symptoms, key limitations of conventional ketamine therapies, were observed. Mean total scores on the Clinician-Administered Dissociative States Scale (CADSS; range: 0-92) remained negligible (=0.7) and comparable to placebo, with no dissociation-related AEs reported. In addition, all subjects remained fully alert throughout the study, indicating a complete absence of sedative effects.
Pharmacokinetic results demonstrated that ALA-3000 delivers sustained ketamine exposure over several weeks following two administrations. Plasma concentrations of ketamine increased gradually, without the pronounced peak levels typically associated with the immediate-release formulation of ketamine. No dose dumping was observed, and ketamine exposure remained steady throughout the study period, highlighting the potential for improved tolerability and differentiated clinical performance.
In exploratory efficacy endpoints, ALA-3000 in combination with an oral antidepressant demonstrated rapid and sustained antidepressant effects, with early onset observed at 24 hours post-dose and separation from placebo from Day 9 onward, as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).
Key findings include:
- Early onset: MADRS total scores decreased as early as 24 hours post-dose
- Sustained improvement: From Day 9 to Day 36, ALA-3000 demonstrated ~3 to 6 points (150 mg) and ~2 to 4 points (250 mg) greater reduction vs. placebo
- Robust response rates: From Day 11 to Day 36, response rates reached =60% (150 mg) and 54% to 69% (250 mg) vs. 36% to 45% for placebo
- Encouraging remission rates: From Day 22 to Day 36, remission rates reached 50% (150 mg) and 23% to 31% (250 mg) vs. 18% for placebo
Collectively, these results highlight the early onset, durable efficacy, and clinically meaningful antidepressant benefit of ALA-3000 in TRD.
Importantly, the long-acting, sustained-release profile of ALA-3000 may offer meaningful clinical advantages, including durable antidepressant effects with reduced burden of frequent dosing and clinical visits. By avoiding rapid peak plasma levels associated with acute ketamine treatment, ALA-3000 mitigates AEs such as dissociation and sedation. This profile has the potential to eliminate the need for mandatory prolonged post-dose clinical on-site monitoring required by current ketamine therapies, significantly enhancing treatment convenience. Furthermore, ALA-3000 may also reduce reliance on psychedelic-assisted psychotherapy, expanding accessibility to a broader patient population.
"ALA-3000 is supported by a robust global intellectual property portfolio, including composition of matter, polymorph, and formulation patents granted across major markets," said Yung-Shun Wen, CEO of Alar Pharmaceuticals. "The clinical results validate our differentiated product and position ALA-3000 as a compelling candidate for global development and licensing partnerships."
"While ketamine has shown robust clinical efficacy in TRD and holds promise in other indications such as post-traumatic stress disorder, fibromyalgia, and Parkinson's disease, its clinical utility has been constrained by pharmacokinetic limitations and psychiatric safety concerns," added Charles Lin, Founder and Chairman of Alar Pharmaceuticals. "ALA-3000 is designed to overcome these barriers, enabling broader adoption and maximizing its therapeutic and commercial value."
For more information, please visit Alar's website at https://alarpharm.com/ and ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06965569
NOTICE: This news release contains specific forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the Company's product development plans, study outcomes, potential therapeutic benefits, regulatory approval processes, and commercial strategy. All forward-looking statements are based on management's current expectations and beliefs only as of the date of this news release and, in addition to the assumptions specifically mentioned in the above paragraphs, there are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Alar disclaims any intention or obligation to update publicly or revise such statements, whether as a result of new information, future events or otherwise.
SOURCE Alar Pharmaceuticals Inc.
