February 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.

Data Supports Potential of Negative Allosteric Modulators for Anxiety and Fear-Related Disorders

Newly published data shows negative allosteric modulator targeting metabotropic glutamate receptor 7 (mGlu7) may be transformative in treating anxiety and fear-related disorders such as posttraumatic stress disorder. Preclinical data from Addex suggests mGlu7 modulation with ADX71743 can alter reconsolidation of fear memories, a potential intervention point in anxiety and trauma-related disorders. ADX71743 disrupted fear memory reconsolidation in rats, requiring recall and a defined post-recall window, and produced conditioned stimulus–specific weakening with reduced fear reinstatement.

Extension of Expanded Access Program for Zervimesine to Treat Dementia With Lewy Bodies

An extension has been announced for the expanded access program of zervimesine to treat dementia with Lewy bodies. The original expanded access program was planned for 12 months, and the extension will now add several more months of treatment for patients. Zervimesine (CT1812) is a sigma-2 receptor modulator that blocks binding and displaces A-beta and alpha-synuclein oligomers from receptor sites to preserve neuronal synapses and normalize neural functioning. In previous preclinical studies, zervimesine was shown to antagonize binding of A-beta oligomers to neuronal synapses, protect neuronal synapses, and restore membrane trafficking deficits cause by A-beta oligomers.

NDA Accepted and Priority Review Granted: Oveporexton for Narcolepsy Type 1

The FDA has accepted Takeda’s New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2-selective agonist specifically designed to address orexin deficiency, an underlying issue that causes NT1, by restoring orexin signaling. If successful, this would be the first approved orexin agonist treatment to individuals living with NT1.

Denovo Biopharma Partners With Orygen for Phase 2 Study of Pomaglumetad Methionil in Treating Psychosis

Denovo Biopharma is partnering with Orygen and plans to initiate a phase 2 investigator-initiated-trial studying pomaglumetad methionil (DB103) for first-episode psychosis (FEP) or clinical high risk (CHR) of psychosis. Orygen is Australia’s leading nonprofit youth mental health organization. Pomaglumetad methionil, a first-in-class psychiatric drug that selectively acts on the glutamic acid mGlu2/3 receptor, has no cross-reaction with other receptors in the central nervous system and therefore can avoid some usual adverse effects of currently-available psychiatric drugs.

Lisdexamfetamine Dimesylate Oral Solution for ADHD to Be Available Mid-2026

Azurity Pharmaceuticals has announced that lisdexamfetamine dimesylate (Arynta) oral solution will be available mid-2026 for treating attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. Arynta gained US Food and Drug Administration approval back on June 16, 2025, for the treatment of ADHD in adults and pediatric patients 6 years and older, and moderate to severe binge eating disorder in adults.

Buntanetap for Neurodegenerative Diseases: Positive Recommendation From Data and Safety Monitoring Board

An independent Data and Safety Monitoring Board (DSMB) issued a positive recommendation regarding the safety of Annovis Bio’s buntanetap—an investigational oral therapy for neurodegenerative diseases such as Alzheimer disease (AD) and Parkinson disease—at 6 months. This supports the continuation of the ongoing buntanetap pivotal phase 3 AD clinical trial (NCT06709014) without any modification.

Strategy Confirmed With FDA for Phase 2b/3 Study of XPro1595 to Treat Early Alzheimer Disease

INmune Bio confirmed receipt of notes from the FDA on continuing the proposed integrated phase 2b/3 clinical development of XPro1595 for early Alzheimer disease. The company aligned regulatory strategy with FDA recommendations and will continue its drug development strategy. The phase 2b study will include an integrated design, with approximately 300 participants over a 9-month evaluation period to validate efficacy and biomarkers assumptions before the phase 3 element continues. The complete phase 3 program is expected to enroll over 1000 participants, evaluating over 18 months. For a primary efficacy endpoint, the study will use the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). Patients will be enrolled based on 2 or more biomarkers associated with peripheral inflammation and immune-mediated disease risk (high sensitivity C-reactive protein, erythrocyte sedimentation rate, hemoglobin A1c, and apolipoprotein E4), which are known to be linked with soluble TNF signaling.

COMP360 Psilocybin for Treatment-Resistant Depression Achieves Primary Endpoint in Phase 3 Trial

Compass Pathways recently announced the successful achievement of the primary endpoint in the ongoing phase 3 COMP006 trial evaluating 2 fixed doses of COMP360—a synthetic, proprietary formulation of psilocybin for managing treatment-resistant depression. The primary endpoint was the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale scores between the 25 mg and 1 mg groups at week 6. Two fixed doses—administered 3 weeks apart—of COMP360 25 mg vs 1 mg demonstrated a highly statistically significant reduction in symptom severity (P<0.001) and a clinically meaningful difference of -3.8 points in change at the primary endpoint.

Phase 2a Trial Meets Endpoints for Psychedelic SPL026 to Treat Major Depressive Disorder

Helus Pharma’s SPL026 met its primary endpoint in a phase 2a trial, showing clinically significant reduction in depression symptoms. The drug, a form of intravenous dimethyltryptamine psychedelic, showed antidepressant effects within a week of treatment, and sustained effects for up to 3 months. Helus Pharma does not plan to advance the drug in its current form, but stated that the mechanistic and clinical insights from the trial will continue to inform the company’s drug development programs.

Phase 2 Study of CYC-126 for Treatment Resistant Depression Receives FDA Feedback, Will Proceed

Cyclerion Therapeutics, developers of CYC-126, received positive feedback from the FDA on the drug’s phase 2 study and path forward to potential regulatory approval. The investigational drug is an anesthetic-based therapy incorporating live electroencephalogram feedback to address treatment-resistant depression. The intended study is a randomized, double-blind, 2-part clinical study evaluating the drug in adults with treatment resistant depression who are also candidates for monitored anesthesia. The trial will use FDA-accepted clinical endpoints, including the Montgomery-Asberg Depression Rating Scale, and will assign participants randomly to treatment or placebo groups. Assessments of safety, efficacy, and durability of response will be the main focus.

NDA Accepted: Olanzapine Extended-Release Injectable Suspension for Treatment of Schizophrenia

Teva Pharmaceuticals recently announced that the FDA accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of adults with schizophrenia. The NDA was submitted to the FDA in December 2025. TEV-'749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) of the second-generation atypical antipsychotic olanzapine. The NDA for TEV-'749 is based on results from the phase 3 SOLARIS trial, including week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.

FDA Approves Bysanti for Treatment of Bipolar 1 Disorder and Schizophrenia

The FDA has approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) for treatment of acute bipolar disorder and schizophrenia. Bysanti is a new chemical entity in the atypical antipsychotic class, providing a novel therapeutic option. Bysanti is expected to be available in the US for schizophrenia and bipolar 1 disorder later in 2026.

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