March 2026 in Review: Updates on the Psychiatric Treatment Pipeline

Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

BXCL501 for Treatment of Opioid Withdrawal: Positive Phase 2 Topline Results

BioXcel Therapeutics announced positive topline results from a phase 2 investigator-sponsored trial evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper. Study data suggest that BXCL501 may be as effective as or superior to lofexidine (Lucemyra) for reducing the symptoms of opioid withdrawal during a methadone taper, while also possessing a more convenient dosing regimen and a favorable tolerability profile. In this study, BXCL501 240 µg twice daily reduced opioid withdrawal symptoms compared with placebo during a 7-day methadone taper.

New Phase 2 Signal Detection Results: HLP004 for Moderate-to-Severe Generalized Anxiety Disorder

Helus Pharma announced topline results from a phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (GAD) who remained symptomatic despite ongoing standard of care antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. As no adjunctive pharmacologic treatments for GAD have ever been approved, and the last new monotherapy was approved almost 2 decades ago, any new treatment in this area has potential to transform the GAD treatment space.

Phase 2 Clinical Study of AL001 Initiated for Bipolar Disorder Type 1

Alzamend Neuro has announced the initiation of a phase 2 clinical study of AL001 in patients diagnosed with bipolar disorder (BD) type 1. AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Investigators of the study will utilize a crossover design intended for multiple 6-subject cohorts. Following screening, participants will be randomized into 1 of 2 treatment sequences: AB (AL001 followed by lithium carbonate) or BA (lithium carbonate followed by AL001). Each treatment period consists of 14 days of 3-times daily dosing. A washout period of 14 days is planned between treatment periods. During days 14 and 15 of each treatment period, participants will undergo intensive 24-hour lithium pharmacokinetic blood sampling along with advanced magnetic resonance imaging and magnetic resonance spectroscopy neuroimaging.

BPL-003 Nasal Spray Shows Quick and Enduring Effect in Treatment-Resistant Depression

BPL-003, mebufotenin benzoate nasal spray, showed reduced depressive symptoms and sustained response rates in patients with moderate to severe treatment-resistant depression. Further cohort data from the 4-part phase 2a trial have been published showing efficacy and safety of the medication in this unique form. Recently published data were gathered from cohort 1 of the phase 2a study, which included 12 participants with treatment-resistant depression in a 12-week, open-label trial. Participants included 2 women and 10 men of ages 31 to 55, and all completed the trial. Participants were not taking any concomitant antidepressants. A 10 mg dose of intranasal BPL-003 was administered, then change in Montgomery-Asberg Depression Rating Scale (MADRS) score and remission were measured at days 2, 8, 29, 57, and 85 post-dose.

Updates on Blarcamesine and Lecanemab for Alzheimer Disease From AD/PD 2026

Anavex Life Sciences shared new data on blarcamesine and Esai presented new analysis of intravenous lecanemab at the International Conference on Alzheimer’s and Parkinson’s Diseases in Copenhagen, Denmark, March 17-21, 2026. In the the AD-004 phase 2b/3 trial, the long-term data on blarcamesine showed 77.4 weeks (nearly 18 months) time saved with oral blarcamesine treatment, compared with controls, after 144 weeks of treatment. Additionally, analysis of long-term treatment persistence with IV lecanemab in patients with early Alzheimer disease showed most patients continued the medication past 18 months. Throughout the long-term study, 78.4% of patients continued treatment at 18 months, 71.7% continued at 20 months, and 67.3% continued at 24 months. This finding is consistent with the previous phase 3 Clarity AD study, in which 94% of patients completing 18 months of lecanemab treatment chose to continue maintenance treatment in the open-label extension. Patients in the Clarity AD study who continued lecanemab showed benefits from 4 years of treatment, compared with the natural course of Alzheimer disease.

New Pivotal Phase 3 Trial: LB-102 for Treatment of Schizophrenia

LB Pharmaceuticals has initiated the pivotal phase 3 NOVA-2 trial evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia. LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors. It is the first potential benzamide in the US for the treatment of neuropsychiatric disorders.

Tazbentetol for Schizophrenia Shows Symptom Improvement in Phase 2 Trial

Interim results from a phase 2 trial of tazbentetol for treatment of schizophrenia showed trends of improving positive and negative symptoms in patients via synaptic regeneration. The safety profile was overall favorable, and biomarker signals indicated improvements in cortical abnormalities associated with schizophrenia. The interim analysis was presented at the Schizophrenia International Research Society 2026 Annual Congress.

First Expert Consensus Recommendations for Tardive Dyskinesia in Long-Term Care Settings

Alongside consensus recommendations focused on the screening, diagnosis, and treatment of tardive dyskinesia (TD), Neurocrine Biosciences presented a first-of-its-kind post-hoc analysis from the KINECT‑PRO study at the Society for Post-Acute and Long-Term Care Medical Association PALTC26 Annual Conference. Valbenazine (Ingrezza) capsules demonstrated meaningful improvements in patient‑reported TD impact among adults aged 65 years and older. In adults aged 65 and older, once-daily Ingrezza was associated with robust patient-reported improvements in TD symptoms, quality of life and functional impairment at week 24. Patient-reported outcomes also demonstrated reduced social and emotional burden, with improvements in total TDIS scores exceeding the established threshold for clinically meaningful change.

Phase 2 Trial of LB-102 for Schizophrenia Shows Positive Impact on Cognitive Performance

LB Pharmaceuticals presented a phase 2 post hoc analysis of the NOVA-1 clinical trial investigating LB-102 for the treatment of schizophrenia at the 2026 Schizophrenia International Research Society meeting in Florence, Italy. The analysis confirmed that cognitive performance improvement was statistically significant and directly related to LB-102. Based on measurement of the Global Cognition composite score, analysis showed improved cognitive performance was a direct effect of LB-102. Generally, the phase 2 trial showed statistically significant effects of LB-102 compared with placebo at all doses tested.

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