Teva completes registration for schizophrenia drug trial

MONTPELIER, France – Teva Pharmaceutical Industries Ltd. announced the completion of patient enrollment in a Phase 3 trial of mdc-TJK, a potential new treatment for schizophrenia. The trial has enrolled 640 participants in the EU and the United States, with results expected in the second half of 2024.

The drug, mdc-TJK (TEV-44749), is a once-monthly subcutaneous injection that represents a formulation of the atypical antipsychotic olanzapine. It is being developed as a long-acting option and may well be the first of its kind to offer good safety profiles. This development is an important step, especially considering that olanzapine long-acting injection (LAI) currently carries the FDA’s boxed warning for post-injection delirium/sedation syndrome (PDSS), which has expired.

Teva is leading the development of the olanzapine LAI and will be responsible for its global commercialization. MedinCell, a biopharmaceutical company specializing in long-acting injectable drugs, will receive up to $117 million in development and commercial milestones for mdc-TJK, as well as pure sales royalties.

MedinCell’s proprietary BEPO® technology enables controlled long-term drug delivery, followed by the FDA’s approval of UZEDY™, a schizophrenia treatment, in April 2023. UZEDY™ is marketed in the United States through Teva under the license name SteadyTeq™.

The partnership between Teva and MedinCell underscores our commitment to advancing treatment options for schizophrenia, a chronic brain disease that affects approximately 1% of the world’s population. Completion of enrollment in the mdc-TJK trial marks an important milestone in their joint effort to improve treatment efficacy and patient compliance.

This report is based on a press release.

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