Medincell’s Phase 3 trial for long-acting injectable olanzapine in schizophrenia reaches completion

Medincell has announced the successful completion of the pivotal Phase 3 SOLARIS clinical trial for its long-acting injectable olanzapine (LAI), developed in partnership with Teva Pharmaceuticals. This milestone marks a significant advancement in the treatment of schizophrenia, with the potential to reshape therapeutic approaches for patients requiring consistent, long-term symptom management. As part of the agreement between Medincell and Teva, the trial’s completion triggers a $5 million milestone payment to Medincell, underscoring the progress made in bringing this innovative therapy closer to market.

A potential breakthrough in schizophrenia treatment

The SOLARIS trial represents a critical step in addressing the long-standing challenges associated with schizophrenia treatment, particularly concerning medication adherence and relapse prevention. Schizophrenia is a chronic mental health condition characterised by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Current treatment regimens often rely on daily oral antipsychotic medications, which can be difficult for patients to maintain consistently, leading to an increased risk of relapse and hospitalisation.

Medincell’s long-acting injectable olanzapine aims to mitigate these issues by offering a once-monthly, subcutaneous injection that provides steady medication levels, reducing the need for daily dosing. This formulation is designed to improve patient compliance, support better long-term outcomes, and potentially decrease the overall healthcare burden associated with schizophrenia management.

Clinical trial results highlight strong efficacy and safety profile

The SOLARIS study, conducted in two distinct phases, was designed to evaluate both the efficacy and safety of the long-acting injectable olanzapine. In the first phase, an eight-week, randomised, double-blind, placebo-controlled trial assessed the drug’s effectiveness in patients diagnosed with schizophrenia. The results were promising, with the investigational treatment, identified as TEV-‘749 (also known as mdc-TJK), meeting its primary efficacy endpoint across all three dosing groups.

Patients receiving TEV-‘749 demonstrated statistically significant improvements in their Positive and Negative Syndrome Scale (PANSS) scores from baseline to week eight. The PANSS score is a widely used tool for measuring symptom severity in schizophrenia, with lower scores indicating reduced symptomatology. The observed improvements were consistent across dosing groups, with p-values below 0.0001, indicating that the likelihood of these results occurring by chance was extremely low.

In addition to its efficacy, the safety profile of TEV-‘749 remained consistent with that of existing oral olanzapine formulations, with no new safety concerns identified. Notably, the study reported no cases of Post-Injection Delirium/Sedation Syndrome (PDSS), a rare but serious complication associated with other long-acting injectable olanzapine products. This outcome suggests that Medincell’s proprietary drug delivery technology may offer a safer alternative to current treatments, potentially eliminating the need for intensive post-injection monitoring.

Regulatory submission process underway

With the successful completion of the SOLARIS trial, Teva Pharmaceuticals is preparing for regulatory submission to the United States Food and Drug Administration (FDA). This submission will include comprehensive data from the trial, encompassing both efficacy and long-term safety results. The full safety data is expected to be released in the second quarter of 2025, with a New Drug Application (NDA) submission anticipated in the second half of the year.

The regulatory submission process is a critical step in bringing new therapies to market. It involves a thorough review of clinical trial data to ensure the drug’s safety, efficacy, and manufacturing quality meet stringent standards. If approved, Medincell’s long-acting injectable olanzapine could offer a new option for patients with schizophrenia, particularly those who struggle with daily medication adherence.

How Medincell’s technology is reshaping drug delivery

At the core of this innovation is Medincell’s proprietary co-polymer technology, licensed to Teva under the name SteadyTeq™. This technology enables a controlled, steady release of medication over an extended period, maintaining therapeutic drug levels with just a single monthly injection. TEV-‘749 is the second drug developed through the Medincell-Teva partnership, following the FDA approval of UZEDY® in April 2023.

The potential benefits of long-acting injectable olanzapine extend beyond improved adherence. By providing consistent drug exposure, the formulation may reduce the risk of symptom fluctuations, improve overall patient stability, and decrease the likelihood of hospital readmissions. Additionally, eliminating the risk of PDSS could enhance patient safety and reduce the need for resource-intensive monitoring protocols.

Medincell’s partnership with Teva also includes provisions for commercialisation, with Teva leading the regulatory process and managing market distribution. Medincell will receive royalties on net sales in addition to development and commercial milestone payments, positioning the company for continued growth as its innovative drug delivery technologies gain wider adoption.

The future of schizophrenia treatment

The successful completion of the SOLARIS trial signals a promising future for patients living with schizophrenia. Long-acting injectable olanzapine represents more than just an incremental improvement in antipsychotic therapy—it reflects a shift towards patient-centric treatment models that prioritise convenience, safety, and long-term health outcomes.

As Teva prepares for regulatory submission and potential FDA approval, the pharmaceutical industry will closely watch the progress of this groundbreaking therapy. If approved, it could redefine the standard of care for schizophrenia, offering new hope to patients and healthcare providers alike.

Medincell’s continued focus on innovative drug delivery solutions underscores its commitment to improving global health outcomes. By addressing critical gaps in current treatment paradigms, the company is poised to make a lasting impact on the lives of individuals affected by complex medical conditions like schizophrenia.