Medincell Partner Teva Presents New Data on Investigational Olanzapine LAI and UZEDY at Psych Congress 2026
Medincell’s partner Teva Pharmaceuticals presented new clinical and real-world data on two long-acting injectable (LAI) antipsychotic treatments incorporating Medincell’s proprietary BEPO® drug delivery technology, licensed to Teva under the SteadyTeq™ platform. The findings were presented at Psych Congress 2026, held September 15–19 in New Orleans, Louisiana, highlighting ongoing efforts to improve treatment continuity and long-term disease management for people living with serious mental health conditions.
The presentations covered Teva’s investigational once-monthly subcutaneous olanzapine LAI for schizophrenia as well as UZEDY®, an approved long-acting injectable treatment. The new analyses provide additional information on treatment stabilization, relapse, remission and potential treatment-switching strategies for olanzapine LAI, while real-world studies involving UZEDY examined treatment continuity, healthcare resource utilization and outcomes among people with schizophrenia and bipolar I disorder.
Together, the findings highlight the potential role of long-acting injectable therapies in addressing challenges associated with adherence and treatment continuity in chronic psychiatric disorders.
New Phase 3 Findings for Investigational Olanzapine LAI
One of the key presentations at Psych Congress 2026 involved new post hoc analyses from the Phase 3 SOLARIS study evaluating Teva’s investigational once-monthly subcutaneous olanzapine LAI in adults with schizophrenia.
Schizophrenia is a chronic psychiatric disorder that often requires long-term treatment. Although oral antipsychotic medicines can be effective, maintaining consistent treatment over time can be challenging for some patients. Long-acting injectable formulations are designed to provide sustained medication exposure and may offer an alternative approach for patients and healthcare professionals seeking longer-duration treatment options.
The SOLARIS analyses focused on outcomes during the long-term treatment period and examined stabilization, relapse and remission among participants receiving the investigational olanzapine LAI.
According to the data presented by Teva, 56% of participants achieved stabilization during the long-term treatment period. Among those who achieved stabilization, only 4% subsequently experienced a relapse. In addition, 21% of participants who received treatment for at least six months met the study criteria for remission.
These findings provide additional insight into the durability of clinical response among patients who remained on treatment during the longer-term phase of the study.
Stabilization and Relapse Remain Important Treatment Goals
For people living with schizophrenia, achieving stabilization is an important part of long-term disease management. Stabilization generally involves control of acute symptoms followed by maintenance of clinical improvement.
Preventing relapse is another major objective because recurrent episodes can affect functioning, quality of life and the continuity of treatment. Relapses may also require additional clinical intervention or changes to medication.
The SOLARIS post hoc analyses showed that among participants who achieved stabilization, a relatively small proportion subsequently met the study definition for relapse during the long-term treatment period.
The remission findings provide another perspective on treatment outcomes. Among participants who had received treatment for at least six months, 21% met the study criteria for remission. While remission represents a stringent treatment outcome, the finding adds to the broader assessment of how patients responded during continued treatment.
Because the analyses were post hoc, the findings should be interpreted within the context of the overall SOLARIS clinical development program rather than as evidence from a prospectively designed primary endpoint.
Potential Treatment-Switching Strategies
Teva also presented additional analyses examining potential approaches for switching patients to the investigational once-monthly olanzapine LAI from existing olanzapine treatment regimens.
The analyses included patients transitioning from oral olanzapine and those receiving short-acting injectable olanzapine.
Treatment switching can be an important consideration in psychiatric care because patients may move between formulations based on clinical response, tolerability, treatment preferences or other practical factors. Understanding how patients can transition between treatment modalities may help inform future clinical use if an investigational therapy receives regulatory approval.
The additional SOLARIS analyses therefore provide information on potential treatment pathways involving the investigational LAI formulation.
However, the olanzapine LAI remains investigational. It has not been approved by any regulatory authority, and the data presented at Psych Congress do not constitute regulatory authorization.
FDA Decision Expected Later in 2026
Teva is continuing the regulatory process for the investigational olanzapine LAI in the United States. A decision from the U.S. Food and Drug Administration (FDA) is expected in the fourth quarter of 2026 under the Prescription Drug User Fee Act (PDUFA) timeline.
If approved, the once-monthly subcutaneous formulation could provide another long-acting treatment option for adults with schizophrenia.
The potential product also represents an application of Medincell’s BEPO technology, which is designed to enable controlled and sustained delivery of medicines following subcutaneous administration.
The technology has been licensed to Teva as SteadyTeq, forming part of the companies’ collaboration around long-acting injectable treatments.
Real-World Evidence for UZEDY
In addition to the investigational olanzapine program, Teva presented new real-world evidence concerning UZEDY.
UZEDY is a long-acting injectable antipsychotic treatment, and the new analyses evaluated its performance in routine clinical practice rather than exclusively within the controlled environment of randomized clinical trials.
One analysis examined treatment continuity among adults with schizophrenia and compared UZEDY with several other long-acting injectable antipsychotic therapies.
The findings showed favorable treatment continuity for UZEDY compared with the evaluated LAI antipsychotics. Treatment continuity is an important consideration in schizophrenia because maintaining a consistent therapeutic regimen can be challenging over the course of a chronic illness.
Real-world evidence can provide additional context around how treatments are used outside clinical trials, where patients may have different characteristics, comorbidities, treatment histories and healthcare needs.
Healthcare Resource Utilization Findings
Another real-world analysis presented at Psych Congress evaluated healthcare resource utilization among adults receiving UZEDY.
According to the findings presented by Teva, treatment with UZEDY was associated with lower healthcare resource utilization compared with once-monthly paliperidone palmitate.
Healthcare resource utilization can include factors such as hospitalizations, emergency department visits and other healthcare services. Such measures can provide an additional perspective on the broader impact of treatment beyond symptom control.
However, as with other observational analyses, real-world comparisons can be influenced by differences in patient populations, treatment selection and other factors that may not be fully controlled in routine clinical datasets.
The results nevertheless add to the growing body of real-world evidence surrounding long-acting injectable antipsychotic treatment.
Data in Bipolar I Disorder
Teva also presented analyses involving adults with bipolar I disorder who switched from oral antipsychotic treatment to UZEDY.
Bipolar I disorder is characterized by episodes of mania that may occur alongside depressive episodes and requires long-term management for many patients. Antipsychotic medicines can play an important role in treatment, while maintaining continuity of therapy can be an important part of disease management.
The UZEDY analysis evaluated outcomes among adults who transitioned from oral antipsychotics to the long-acting injectable treatment.
These findings contribute to understanding how LAI treatment may be incorporated into treatment pathways for patients with bipolar I disorder. They also reflect the broader interest in long-acting formulations as an approach to supporting sustained treatment delivery.
BEPO Technology Underpins Collaboration
The data presented at Psych Congress also underscore the role of Medincell’s proprietary BEPO technology in its collaboration with Teva.
BEPO is a long-acting drug delivery platform designed to provide controlled release of medicines over extended periods following administration. Under its licensing arrangement with Teva, the technology is known as SteadyTeq.
Long-acting drug delivery technologies are being explored across several therapeutic areas because they can potentially reduce the frequency of administration compared with daily oral medicines.
For psychiatric disorders, where long-term treatment continuity can be challenging, extended-release injectable formulations may offer an alternative that reduces the need for frequent medication administration.
The investigational once-monthly olanzapine formulation represents one application of this approach, while UZEDY provides an existing example of a long-acting injectable treatment using the technology.
Broader Importance of Long-Acting Psychiatric Treatments
The presentations at Psych Congress 2026 reflect continued interest in developing treatment options that address not only efficacy but also practical challenges associated with long-term psychiatric care.
Schizophrenia and bipolar I disorder can require ongoing management, and treatment decisions may involve considerations such as symptom control, relapse prevention, treatment continuity, tolerability and patient preferences.
Long-acting injectable therapies can provide sustained medication delivery and may reduce the need for daily dosing. They may also allow healthcare providers to identify treatment administration more reliably than with oral medication alone, although the suitability of an LAI varies among individual patients.
The real-world findings for UZEDY and the longer-term SOLARIS analyses for investigational olanzapine LAI add different types of evidence to this field.
The new data presented by Teva at Psych Congress 2026 expand the clinical and real-world evidence surrounding treatments incorporating Medincell’s BEPO technology.
For the investigational olanzapine LAI, the SOLARIS analyses showed that 56% of participants achieved stabilization during the long-term treatment period, while 4% of stabilized participants subsequently relapsed. Among participants treated for at least six months, 21% met study criteria for remission. Additional analyses explored potential transitions from oral and short-acting injectable olanzapine to the once-monthly formulation.
Meanwhile, real-world analyses of UZEDY provided evidence on treatment continuity among adults with schizophrenia, healthcare resource utilization compared with once-monthly paliperidone palmitate, and treatment outcomes among adults with bipolar I disorder switching from oral antipsychotics.
The investigational olanzapine LAI remains under regulatory review, with a U.S. FDA PDUFA decision expected in the fourth quarter of 2026. Until a regulatory decision is issued, its safety and efficacy remain subject to the ongoing regulatory evaluation.
The latest findings nevertheless represent an additional step in the development of long-acting treatment approaches in psychiatry and demonstrate the continued collaboration between Teva and Medincell around sustained-release drug delivery technologies.
About Medincell
Medincell is a clinical- and commercial-stage innovation-driven biopharmaceutical company developing and licensing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.